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Mechanisms of Manual Therapies in CAI Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03418051
Recruitment Status : Completed
First Posted : February 1, 2018
Results First Posted : August 27, 2021
Last Update Posted : August 27, 2021
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE January 24, 2018
First Posted Date  ICMJE February 1, 2018
Results First Submitted Date  ICMJE July 24, 2021
Results First Posted Date  ICMJE August 27, 2021
Last Update Posted Date August 27, 2021
Actual Study Start Date  ICMJE September 1, 2018
Actual Primary Completion Date October 9, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2021)
  • ML COP Velocity From Baseline to Post Intervention [ Time Frame: Baseline and 24-72 hours post intervention ]
    % Modulation of ML COP velocity. First, center of pressure (COP) is calculated in the mediolateral (ML) direction [side to side] with eyes open and closed. COP velocity represents the average speed at which an individual's COP moves during the 10 second single limb stance trial. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML COP Velocity that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as ML COP velocity increased when eyes were closed relative to the eyes open condition. A ML COP velocity change greater than the eyes open value would result in a value >100%. This analysis focused on baseline to the immediate post-treatment assessment.
  • ML COP Velocity From Baseline to Follow-Up [ Time Frame: Baseline and 4-week Follow-Up ]
    % Modulation of ML COP velocity. First, center of pressure (COP) is calculated in the mediolateral (ML) direction [side to side] with eyes open and closed. COP velocity represents the average speed at which an individual's COP moves during the 10 second single limb stance trial. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML COP Velocity that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as ML COP velocity increased when eyes were closed relative to the eyes open condition. A ML COP velocity change greater than the eyes open value would result in a value >100%. This analysis focused on baseline to the Follow-Up assessment.
  • AP COP Velocity From Baseline to Post Intervention [ Time Frame: Baseline and 24-72 hours post intervention ]
    % Modulation of AP COP velocity. First, center of pressure (COP) is calculated in the anterioposterior (AP) direction [front to back]. COP velocity represents the average speed at which an individual's COP moves during the 10 second single limb stance trial. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML COP Velocity that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as ML COP velocity increased when eyes were closed relative to the eyes open condition. A ML COP velocity change greater than the eyes open value would result in a value >100%. This analysis focused on baseline to the immediate post-treatment assessment.
  • AP COP Velocity From Baseline to Follow-up [ Time Frame: Baseline and 4-week Follow-Up ]
    % Modulation of AP COP velocity. First, center of pressure (COP) is calculated in the anterioposterior (AP) direction [front to back] with eyes open and closed. COP velocity represents the average speed at which an individual's COP moves during the 10 second single limb stance trial. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML COP Velocity that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as ML COP velocity increased when eyes were closed relative to the eyes open condition. A ML COP velocity change greater than the eyes open value would result in a value >100%. This analysis focused on baseline to the follow-up assessment.
  • ML TTB From Baseline to Post Intervention [ Time Frame: Baseline and 24-72 hours post intervention ]
    % Modulation of ML Time-to-Boundary. First, time-to-Boundary (TTB) is calculated in the mediolateral (ML) direction [side to side] with eyes open and closed. TTB represents the time (s) it would take for a participant's center of pressure (i.e. vertical projection of the center of mass) to reach their base of support (i.e. boundary) based on the instantaneous position and velocity of the center of pressure. The base of support is represents the length and width of an individual's foot. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML TTB that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes open balance score - eyes closed balance score) / eyes open balance score. Negative scores indicate a greater reliance on visual information as ML TTB decreased with eyes closed.
  • ML TTB From Baseline to Follow-Up [ Time Frame: Baseline and 4-week Follow-Up ]
    % Modulation of ML Time-to-Boundary. First, time-to-Boundary (TTB) is calculated in the mediolateral (ML) direction [side to side] with eyes open and closed. TTB represents the time (s) it would take for a participant's center of pressure (i.e. vertical projection of the center of mass) to reach their base of support (i.e. boundary) based on the instantaneous position and velocity of the center of pressure. The base of support is represents the length and width of an individual's foot. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in ML TTB that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes open balance score - eyes closed balance score) / eyes open balance score. Negative scores indicate a greater reliance on visual information as ML TTB decreased with eyes closed.
  • AP TTB From Baseline to Post Intervention [ Time Frame: Baseline and 24-72 hours post intervention ]
    % Modulation of AP Time-to-Boundary. First, time-to-Boundary (TTB) is calculated in the anterioposterior (AP) direction [front to back] with eyes open and closed. TTB represents the time (s) it would take for a participant's center of pressure (i.e. vertical projection of the center of mass) to reach their base of support (i.e. boundary) based on the instantaneous position and velocity of the center of pressure. The base of support is represents the length and width of an individual's foot. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in AP TTB that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes open balance score - eyes closed balance score) / eyes open balance score. Negative scores indicate a greater reliance on visual information as AP TTB decreased with eyes closed.
  • AP TTB From Baseline to Follow-Up [ Time Frame: Baseline and 4-week Follow-Up ]
    % Modulation of AP Time-to-Boundary. First, time-to-Boundary is calculated in the anterioposterior (AP) direction [front to back] with eyes open and closed. Time-to-boundary represents the time (s) it would take for a participant's center of pressure (i.e. vertical projection of the center of mass) to reach their base of support (i.e. boundary) based on the instantaneous position and velocity of the center of pressure. The base of support is represents the length and width of an individual's foot. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change in AP TTB that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes open balance score - eyes closed balance score) / eyes open balance score. Negative scores indicate a greater reliance on visual information as AP TTB decreased with eyes closed.
  • 95% Confidence Ellipse From Baseline to Post Intervention [ Time Frame: Baseline and 24-72 hours post intervention ]
    % Modulation of 95% Confidence Ellipse. First, center of pressure (COP) excursion [movement] is calculated and the magnitude of an ellipse that contains 95% of all data points is calculated with eyes open and closed. The resulting outcome is calculated from a 10 second single limb stance trial. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as the variable increased when eyes were closed relative to the eyes open condition. A change greater than the eyes open value would result in a value >100%. This analysis focused on baseline to the immediate post-treatment assessment.
  • 95% Confidence Ellipse From Baseline to Follow-Up [ Time Frame: Baseline and 4-week Follow-Up ]
    % Modulation of 95% Confidence Ellipse. First, center of pressure (COP) excursion [movement] is calculated and the magnitude of an ellipse that contains 95% of all data points is calculated with eyes open and closed. The resulting outcome is calculated from a 10 second single limb stance trial. Next, % modulation is calculated. This estimates the weight given to visual information during eyes open stance based on the magnitude of change that occurs when vision is removed relative to the eyes open condition (control condition). The following formula is used: % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score. Positive scores indicate a greater reliance on visual information as the variable increased when eyes were closed relative to the eyes open condition. A change greater than the eyes open value would result in a value >100%. This analysis focused on baseline to the immediate post-treatment assessment.
Original Primary Outcome Measures  ICMJE
 (submitted: January 24, 2018)
  • % Modulation Change Immediately Post Intervention [ Time Frame: 24-72 hours post intervention ]
    % Modulation is a measure of an individual's sensory organization strategy. This measure estimates the weight given to visual information during eyes open stance based on the magnitude of postural instability that occurs when vision is removed. % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score
  • % Modulation Change at 4-weeks Post Intervention [ Time Frame: 4-week post intervention ]
    % Modulation is a measure of an individual's sensory organization strategy. This measure estimates the weight given to visual information during eyes open stance based on the magnitude of postural instability that occurs when vision is removed. % Modulation = (eyes closed balance score - eyes open balance score) / eyes open balance score
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2021)
  • Plantar Flexion Joint Position Sense From Baseline to Post Intervention [ Time Frame: Baseline and 24-72 hours post intervention ]
    Amount of error, measured in degrees, from a target angle of plantar flexion. Participants are shown a target ankle and asked to replicate that angle (i.e. joint position) with their eyes closed. The amount of error from the target angle is recorded as the joint position sense. Larger values (i.e. greater error) indicates worse joint position sense. This analysis focused on baseline to the immediate post-treatment assessment.
  • Plantar Flexion Joint Position Sense From Baseline to Follow-Up [ Time Frame: Baseline and 4-week Follow-Up ]
    Amount of error, measured in degrees, from a target angle of plantar flexion. Participants are shown a target ankle and asked to replicate that angle (i.e. joint position) with their eyes closed. The amount of error from the target angle is recorded as the joint position sense. Larger values (i.e. greater error) indicates worse joint position sense. This analysis focused on baseline to the follow-up assessment.
  • 1st Metatarsal Light-touch Threshold From Baseline to Post Intervention [ Time Frame: Baseline and 24-72 hours post intervention ]
    Minimal amount of pressure that can be detected by an individual at the head of the 1st metatarsal. Semmes-Weinstein monofilaments, of different diameters (mm), are pressed against the skin using an established 4-2-1 stepping algorithm. Higher values (thresholds) indicate worse light touch sensation thresholds. his analysis focused on baseline to the immediate post-treatment assessment.
  • 1st Metatarsal Light-touch Threshold From Baseline to Follow-Up [ Time Frame: Baseline and 4-week Follow-Up ]
    Minimal amount of pressure that can be detected by an individual at the head of the 1st metatarsal. Semmes-Weinstein monofilaments, of different diameters (mm), are pressed against the skin using an established 4-2-1 stepping algorithm. Higher values (thresholds) indicate worse light touch sensation thresholds. This analysis focused on baseline to the follow-up assessment.
  • 5th Metatarsal Light-touch Threshold From Baseline to Post Intervention [ Time Frame: Baseline and 24-72 hours post intervention ]
    Minimal amount of pressure that can be detected by an individual at the base of the 5th metatarsal. Semmes-Weinstein monofilaments, of different diameters (mm), are pressed against the skin using an established 4-2-1 stepping algorithm. Higher values (thresholds) indicate worse light touch sensation thresholds. This analysis focused on baseline to the immediate post-treatment assessment.
  • 5th Metatarsal Light-touch Threshold From Baseline to Follow-Up [ Time Frame: Baseline and 4-week Follow Up ]
    Minimal amount of pressure that can be detected by an individual at the base of the 5th metatarsal. Semmes-Weinstein monofilaments, of different diameters (mm), are pressed against the skin using an established 4-2-1 stepping algorithm. Higher values (thresholds) indicate worse light touch sensation thresholds. This analysis focused on baseline to the follow-up assessment.
  • Soleus H:M Ratio From Baseline to Post Intervention [ Time Frame: Baseline and 24-72 hours post intervention ]
    This measure shows the percentage of excited alpha motor neurons (H) within a muscle upon electrical stimulation, relative to the total number of alpha motor neurons in the same muscle (M). Higher scores represent a greater percentage of excitability (i.e. activation) and is thought to represent better function of the spinal motor pathway. This analysis focused on baseline to the immediate post-treatment assessment. The test is performed using an electric stimulator and electromyography (EMG) to record muscle responses. Stimulation intensity is increased on sequential trials to capture both the H-wave and M-wave responses.
  • Soleus H:M Ratio From Baseline to Follow-Up [ Time Frame: Baseline and 4-week Follow-Up ]
    This measure shows the percentage of excited alpha motor neurons (H) within a muscle upon electrical stimulation, relative to the total number of alpha motor neurons in the same muscle (M). Higher scores represent a greater percentage of excitability (i.e. activation) and is thought to represent better function of the spinal motor pathway. This analysis focused on baseline to the immediate post-treatment assessment. The test is performed using an electric stimulator and electromyography (EMG) to record muscle responses. Stimulation intensity is increased on sequential trials to capture both the H-wave and M-wave responses.
  • Fibularis Longus H:M Ratio From Baseline to Post Intervention [ Time Frame: Baseline and 24-72 hours post intervention ]
    This measure shows the percentage of excited alpha motor neurons (H) within a muscle upon electrical stimulation, relative to the total number of alpha motor neurons in the same muscle (M). Higher scores represent a greater percentage of excitability (i.e. activation) and is thought to represent better function of the spinal motor pathway. This analysis focused on baseline to the immediate post-treatment assessment. The test is performed using an electric stimulator and electromyography (EMG) to record muscle responses. Stimulation intensity is increased on sequential trials to capture both the H-wave and M-wave responses.
  • Fibularis Longus H:M Ratio From Baseline to Follow-Up [ Time Frame: Baseline and 4-week Follow-Up ]
    This measure shows the percentage of excited alpha motor neurons (H) within a muscle upon electrical stimulation, relative to the total number of alpha motor neurons in the same muscle (M). Higher scores represent a greater percentage of excitability (i.e. activation) and is thought to represent better function of the spinal motor pathway. This analysis focused on baseline to the immediate post-treatment assessment. The test is performed using an electric stimulator and electromyography (EMG) to record muscle responses. Stimulation intensity is increased on sequential trials to capture both the H-wave and M-wave responses.
  • Fibularis Longus Active Motor Threshold From Baseline to Post Intervention [ Time Frame: Baseline and 24-72 hours post intervention ]
    A measure of cortical excitability using transcranial electromagnetic stimulation. A higher active motor threshold (AMT) indicates decreased excitability, as a greater stimulus intensity is required to elicit a motor evoke potential (MEP). This analysis focused on baseline to the immediate post-treatment assessment.
  • Fibularis Longus Active Motor Threshold From Baseline to Follow-Up [ Time Frame: Baseline and 4-week Follow-Up ]
    A measure of cortical excitability using transcranial electromagnetic stimulation. A higher active motor threshold (AMT) indicates decreased excitability, as a greater stimulus intensity is required to elicit a motor evoke potential (MEP). This analysis focused on baseline to the immediate post-treatment assessment.
  • Cortical Silent Period From Baseline to Post Intervention [ Time Frame: Baseline and 24-72 hours post intervention ]
    A measure of corticospinal inhibition using transcranial electromagnetic stimulation. The cortical silent period (CSP) will be measured as the distance from the end of the motor evoked potential (MEP) to a return of the mean electromyographic (EMG) signal plus two times the standard deviation of the baseline (pre-stimulus) EMG signal. A longer CSP indicates a greater corticospinal inhibition. This analysis focused on baseline to the immediate post-treatment assessment.
  • Cortical Silent Period From Baseline to Follow-Up [ Time Frame: Baseline and 4-week Follow-Up ]
    A measure of corticospinal inhibition using transcranial electromagnetic stimulation. The cortical silent period (CSP) will be measured as the distance from the end of the motor evoked potential (MEP) to a return of the mean electromyographic (EMG) signal plus two times the standard deviation of the baseline (pre-stimulus) EMG signal. A longer CSP indicates a greater corticospinal inhibition. This analysis focused on baseline to the follow-up assessment.
  • Corticomotor Map Area From Baseline to Post Intervention [ Time Frame: Baseline and 24-72 hours post intervention ]
    A measure representing the size of a muscle's cortical representation using transcranial electromagnetic stimulation. Map area is the number of stimulus positions whose stimulation evoked an average motor evoked potential ≥ the motor evoked potential threshold. An increase would suggest an expansion of the cortical representation of a selected muscle. This analysis focused on baseline to the immediate post-treatment assessment.
  • Corticomotor Map Area From Baseline to Follow-Up [ Time Frame: Baseline and 4-week Follow-Up ]
    A measure representing the size of a muscle's cortical representation using transcranial electromagnetic stimulation. Map area is the number of stimulus positions whose stimulation evoked an average motor evoked potential ≥ the motor evoked potential threshold. An increase would suggest an expansion of the cortical representation of a selected muscle. This analysis focused on baseline to the follow-up assessment.
  • Corticomotor Map Volume From Baseline to Post Intervention [ Time Frame: Baseline and 24-72 hours post intervention ]
    A measure representing the size of a muscle's cortical representation using transcranial electromagnetic stimulation. Map volume will be calculated as the sum of the mean normalized MEPs recorded with an increase suggesting greater cortical excitability. This analysis focused on baseline to the immediate post-treatment assessment.
  • Corticomotor Map Volume From Baseline to Follow-Up [ Time Frame: Baseline and 4-week Follow-Up ]
    measure representing the size of a muscle's cortical representation using transcranial electromagnetic stimulation. Map volume will be calculated as the sum of the mean normalized MEPs recorded with an increase suggesting greater cortical excitability. This analysis focused on baseline to the immediate post-treatment assessment.
  • Alpha Power Spectral Density From Baseline to Post Intervention [ Time Frame: Baseline and 24-72 hours post intervention ]
    A measure of cortical activation using electroencephalography. Power spectral density (PSD) reflects the distribution of signal power over frequency (micro Volts). Higher PSDs indicate more cortical activity within the alpha bandwidth. This analysis focused on baseline to the immediate post-treatment assessment.
  • Alpha Power Spectral Density From Baseline to Follow-Up [ Time Frame: Baseline and 4-week Follow-Up ]
    A measure of cortical activation using electroencephalography. Power spectral density (PSD) reflects the distribution of signal power over frequency (micro Volts). Higher PSDs indicate more cortical activity within the alpha bandwidth. This analysis focused on baseline to the immediate follow-up assessment.
  • Beta Power Spectral Density From Baseline to Post Intervention [ Time Frame: Baseline and 24-72 hours post intervention ]
    A measure of cortical activation using electroencephalography. Power spectral density (PSD) reflects the distribution of signal power over frequency (micro Volts). Higher PSDs indicate more cortical activity within the beta bandwidth. This analysis focused on baseline to the immediate post-treatment assessment.
  • Beta Power Spectral Density From Baseline to Follow-Up [ Time Frame: Baseline and 4-week Follow-Up ]
    A measure of cortical activation using electroencephalography. Power spectral density (PSD) reflects the distribution of signal power over frequency (micro Volts). Higher PSDs indicate more cortical activity within the beta bandwidth. This analysis focused on baseline to the follow-up assessment.
  • Gamma Power Spectral Density From Baseline to Post Intervention [ Time Frame: Baseline and 24-72 hours post intervention ]
    A measure of cortical activation using electroencephalography. Power spectral density (PSD) reflects the distribution of signal power over frequency (micro Volts). Higher PSDs indicate more cortical activity within the gamma bandwidth. This analysis focused on baseline to the immediate post-treatment assessment.
  • Gamma Power Spectral Density From Baseline to Follow-Up [ Time Frame: Baseline and 4-week Follow-Up ]
    A measure of cortical activation using electroencephalography. Power spectral density (PSD) reflects the distribution of signal power over frequency (micro Volts). Higher PSDs indicate more cortical activity within the gamma bandwidth. This analysis focused on baseline to the follow-up assessment.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2018)
  • Ankle Joint Position Sense at Baseline [ Time Frame: Baseline ]
    Ability to replicate a target angle of ankle inversion.
  • Ankle Joint Position Sense Immediately Post Intervention [ Time Frame: 24-72 hours post intervention ]
    Ability to replicate a target angle of ankle inversion.
  • Ankle Joint Position Sense at 4-weeks Post Intervention [ Time Frame: 4-weeks post intervention ]
    Ability to replicate a target angle of ankle inversion.
  • Plantar light-touch threshold at Baseline [ Time Frame: Baseline ]
    Minimal amount of pressure that can be detected by an individual at the base of the 5th metatarsal using a 4-2-1 stepping algorithm and Semmes-Weinstein monofilaments.
  • Plantar light-touch threshold Immediately Post Intervention [ Time Frame: 24-72 hours post intervention ]
    Minimal amount of pressure that can be detected by an individual at the base of the 5th metatarsal using a 4-2-1 stepping algorithm and Semmes-Weinstein monofilaments.
  • Plantar light-touch threshold at 4-weeks Post Intervention [ Time Frame: 4-weeks post intervention ]
    Minimal amount of pressure that can be detected by an individual at the base of the 5th metatarsal using a 4-2-1 stepping algorithm and Semmes-Weinstein monofilaments.
  • H:M Ratio at Baseline [ Time Frame: Baseline ]
    A measure of spinal reflexive excitability relative to maximal amount of the motor neuron pool that is available to generate a muscle contraction.
  • H:M Ratio Immediately Post Intervention [ Time Frame: 24-72 hours post intervention ]
    A measure of spinal reflexive excitability relative to maximal amount of the motor neuron pool that is available to generate a muscle contraction.
  • H:M Ratio at 4-weeks Post Intervention [ Time Frame: 4-weeks post intervention ]
    A measure of spinal reflexive excitability relative to maximal amount of the motor neuron pool that is available to generate a muscle contraction.
  • Active Motor Threshold at Baseline [ Time Frame: Baseline ]
    A measure of cortical excitability using transcranial electromagnetic stimulation
  • Active Motor Threshold Immediately Post Intervention [ Time Frame: 24-72 hours post intervention ]
    A measure of cortical excitability using transcranial electromagnetic stimulation
  • Active Motor Threshold at 4-weeks Post Intervention [ Time Frame: 4-weeks post intervention ]
    A measure of cortical excitability using transcranial electromagnetic stimulation
  • Cortical Silent Period at Baseline [ Time Frame: Baseline ]
    A measure of corticospinal inhibition using transcranial electromagnetic stimulation
  • Cortical Silent Period Immediately Post Intervention [ Time Frame: 24-72 hours post intervention ]
    A measure of corticospinal inhibition using transcranial electromagnetic stimulation
  • Cortical Silent Period at 4-weeks Post Intervention [ Time Frame: 4-weeks post intervention ]
    A measure of corticospinal inhibition using transcranial electromagnetic stimulation
  • Corticomotor Map Area at Baseline [ Time Frame: Baseline ]
    A measure representing the size of a muscle's cortical representation using transcranial electromagnetic stimulation
  • Corticomotor Map Area Immediately Post Intervention [ Time Frame: 24-72 hours post intervention ]
    A measure representing the size of a muscle's cortical representation using transcranial electromagnetic stimulation
  • Corticomotor Map Area at 4-weeks Post Intervention [ Time Frame: 4-weeks post intervention ]
    A measure representing the size of a muscle's cortical representation using transcranial electromagnetic stimulation
  • Relative Power Spectral Density at Baseline [ Time Frame: Baseline ]
    A measure of cortical activation using electroencephalography
  • Relative Power Spectral Density Immediately Post Intervention [ Time Frame: 24-72 hours post intervention ]
    A measure of cortical activation using electroencephalography
  • Relative Power Spectral Density at 4-weeks Post Intervention [ Time Frame: 4-weeks post intervention ]
    A measure of cortical activation using electroencephalography
Current Other Pre-specified Outcome Measures
 (submitted: August 25, 2021)
  • Walking Ankle Dorsiflexion at Baseline [ Time Frame: Baseline ]
    Dorsiflexion angle of the ankle at initial contact while walking.
  • Walking Ankle Dorsiflexion Immediately Post Intervention [ Time Frame: 24-72 hours post intervention ]
    Dorsiflexion angle of the ankle at initial contact while walking.
  • Walking Ankle Dorsiflexion at 4-weeks Post Intervention [ Time Frame: 4-weeks post intervention ]
    Dorsiflexion angle of the ankle at initial contact while walking.
  • Walking Loading Rate at Baseline [ Time Frame: Baseline ]
    Rate of weight acceptance while walking
  • Walking Loading Rate Immediately Post Intervention [ Time Frame: 24-72 hours post intervention ]
    Rate of weight acceptance while walking
  • Walking Loading Rate at 4-weeks Post Intervention [ Time Frame: 4-weeks post intervention ]
    Rate of weight acceptance while walking
  • Landing Ankle Dorsiflexion at Baseline [ Time Frame: Baseline ]
    Dorsiflexion angle of the ankle at initial contact while landing from a jump
  • Landing Ankle Dorsiflexion Immediately Post Intervention [ Time Frame: 24-72 hours post intervention ]
    Dorsiflexion angle of the ankle at initial contact while landing from a jump
  • Landing Ankle Dorsiflexion at 4-weeks Post Intervention [ Time Frame: 4-weeks post intervention ]
    Dorsiflexion angle of the ankle at initial contact while landing from a jump
  • Landing Loading Rate at Baseline [ Time Frame: Baseline ]
    Rate of weight acceptance while landing from a jump
  • Landing Loading Rate Immediately Post Intervention [ Time Frame: 24-72 hours post intervention ]
    Rate of weight acceptance while landing from a jump
  • Landing Loading Rate at 4-weeks Post Intervention [ Time Frame: 4-weeks post intervention ]
    Rate of weight acceptance while landing from a jump
Original Other Pre-specified Outcome Measures
 (submitted: January 24, 2018)
  • Walking Ankle dorsiflexion at Baseline [ Time Frame: Baseline ]
    Dorsiflexion angle of the ankle at initial contact while walking.
  • Walking Ankle dorsiflexion Immediately Post Intervention [ Time Frame: 24-72 hours post intervention ]
    Dorsiflexion angle of the ankle at initial contact while walking.
  • Walking Ankle dorsiflexion at 4-weeks Post Intervention [ Time Frame: 4-weeks post intervention ]
    Dorsiflexion angle of the ankle at initial contact while walking.
  • Walking Loading Rate at Baseline [ Time Frame: Baseline ]
    Rate of weight acceptance while walking
  • Walking Loading Rate Immediately Post Intervention [ Time Frame: 24-72 hours post intervention ]
    Rate of weight acceptance while walking
  • Walking Loading Rate at 4-weeks Post Intervention [ Time Frame: 4-weeks post intervention ]
    Rate of weight acceptance while walking
  • Landing Ankle dorsiflexion at Baseline [ Time Frame: Baseline ]
    Dorsiflexion angle of the ankle at initial contact while landing from a jump
  • Landing Ankle dorsiflexion Immediately Post Intervention [ Time Frame: 24-72 hours post intervention ]
    Dorsiflexion angle of the ankle at initial contact while landing from a jump
  • Landing Ankle dorsiflexion at 4-weeks Post Intervention [ Time Frame: 4-weeks post intervention ]
    Dorsiflexion angle of the ankle at initial contact while landing from a jump
  • Landing Loading Rate at Baseline [ Time Frame: Baseline ]
    Rate of weight acceptance while landing from a jump
  • Landing Loading Rate Immediately Post Intervention [ Time Frame: 24-72 hours post intervention ]
    Rate of weight acceptance while landing from a jump
  • Landing Loading Rate at 4-weeks Post Intervention [ Time Frame: 4-weeks post intervention ]
    Rate of weight acceptance while landing from a jump
 
Descriptive Information
Brief Title  ICMJE Mechanisms of Manual Therapies in CAI Patients
Official Title  ICMJE Neuromuscular Mechanisms of Manual Therapies in Chronic Ankle Instability Patients
Brief Summary

ABSTRACT:

Injury associated with sport and recreation is a leading reason for physical activity cessation, which is linked with significant long-term negative consequences. Lateral ankle sprains are the most common injuries associated with physical activity and at least 40% of individuals who sprain their ankle will go on to develop chronic ankle instability (CAI), a multifaceted condition linked with life-long residual symptoms and post-traumatic ankle osteoarthritis. Our long term goal is to develop intervention strategies to decrease disability associated with acute and chronic ankle injury and prevent posttraumatic ankle osteoarthritis. Conventional rehabilitation strategies, are only moderately successful because they ignore the full spectrum of residual symptoms associated with CAI. Manual therapies such as ankle joint mobilizations and plantar massage target sensory pathways not addressed by conventional treatments and have been shown to improve patient-reported outcomes, dorsiflexion range of motion, and postural control in CAI patients. While these early results are promising, the underlying neuromuscular mechanisms of these manual therapies remain unknown. Therefore the objective of this R21 proposal is to determine the neuromuscular mechanisms underlying the improvements observed following independent ankle joint mobilization and plantar massage interventions in CAI patients. To comprehensively evaluate the neuromuscular mechanisms of the experimental treatments, baseline assessments of peripheral (ankle joint proprioception, light-touch detection thresholds, spinal (H-Reflex of the soleus and fibularis longus), and supraspinal mechanisms (cortical activation, cortical excitability, and cortical mapping, sensory organization) will be assessed. Participants will then be randomly assigned to receive ankle joint mobilizations (n=20), plantar massage (n=20), or a control intervention (n=20) which will consist of 6, 5-minute treatments over 2-weeks. Post-intervention assessments will be completed within 48-hours of the final treatment session. Separate ANOVAs will assess the effects of treatment group (ankle joint mobilization, plantar massage, control) and time (baseline, post-treatment) on peripheral, spinal, and supraspinal neuromuscular mechanisms in CAI participants. Associations among neuromuscular mechanisms and secondary measures (biomechanics and postural control) will also be assessed. The results of this investigation will elucidate multifaceted mechanisms of novel and effective manual therapies (ankle joint mobilizations and plantar massage) in those with CAI.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Ankle Inversion Sprain
  • Chronic Instability of Joint
Intervention  ICMJE
  • Other: Joint Mobilization
    Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade II anterior to posterior ankle joint mobilizations with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
    Other Name: Ankle Joint Mobilization
  • Other: Massage
    Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
    Other Name: Plantar Massage
Study Arms  ICMJE
  • No Intervention: Control
    Control group that will receive no intervention throughout the duration of the study (2-weeks).
  • Experimental: Joint Mobilization
    Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade III anterior-to-posterior talocrural joint mobilization with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
    Intervention: Other: Joint Mobilization
  • Experimental: Massage
    Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage bouts with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
    Intervention: Other: Massage
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 24, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 9, 2020
Actual Primary Completion Date October 9, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

Individuals with Chronic Ankle Instability which will be defined as those individuals who:

  • have sustained at least two lateral ankle sprains;
  • have experienced at least one episode of giving way within the past 6-months;
  • answer 4 or more questions of "yes" on the Ankle Instability Instrument;
  • have self-assessed disability scores of ≤90% on the Foot and Ankle Ability Measure;
  • have self-assessed disability scores ≤80% on the Foot and Ankle Ability Measure-Sport.

Exclusion criteria for Chronic Ankle Instability will include:

  • known vestibular and vision problems,
  • acute lower extremities and head injuries (<6 weeks),
  • chronic musculoskeletal conditions known to affect balance (e.g., Anterior Cruciate Ligament deficiency) and
  • a history of ankle surgeries to fix internal derangement.

Participants will also be excluded if they have any of the following which are contraindications to Transcranial Magnetic Stimulation testing:

  • metal anywhere in the head (except in the mouth),
  • pacemakers,
  • implantable medical pumps,
  • ventriculo-peritoneal shunts,
  • intracardiac lines,
  • history of seizures,
  • history of stroke
  • history of serious head trauma.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03418051
Other Study ID Numbers  ICMJE 17-2655
1R21AT009704-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: The entire dataset will link the outcomes and demographics but will be devoid of patient identifying information. Upon completion of the study, this information will be available to those who request the data, meet the access criteria, and agree to a data use agreement.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: Data will be available following completion of the study for two years.
Access Criteria: Data will be made available to other investigators that contact the PI and provide written commitment (i.e. data use agreement) to: 1) only use the data for purposes currently unplanned by the principal investigators or co-investigators; 2) only use the data for research purposes and not to contact patients or potential future research subjects; 3) securing the data using appropriate computer technology; as well as 4) destroying or returning the data following completion of data analysis.
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
Principal Investigator: Erik Wikstrom, PhD University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP