Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Additional Neurodynamic Intervention in Patients With Chronic Ankle Instability

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05090423
Recruitment Status : Not yet recruiting
First Posted : October 22, 2021
Last Update Posted : October 22, 2021
Sponsor:
Information provided by (Responsible Party):
Yi-Fen Shih, National Yang Ming University

Brief Summary:

Approximately 40% of acute ankle sprain would develop into chronic ankle instability (CAI). Chronic ankle instability is characterized by pain, repeated sprains and giving way. Recently, the pathomechanical impairment, sensory-perceptual impairment and motor-behavioral impairment have been documented in the chronic ankle instability model. Previous research revealed that compared to the control subjects, people with CAI had lower pressure pain threshold (PPT). This increased mechanosensitivity of the neural tissues around the ankle might account for pain and dysfunction in people with CAI. Also, the other study indicated that in subjects following ankle inversion sprain there is greater restriction of knee extension on the injured side compared to non-injured side in the slump test with the ankle plantar flexion and inversion, which may suggest the restriction in mobility of the common peroneal tract. However, the effects of neurodynamic intervention, which addresses the mechanosensitivity problems, in people with CAI are still unclear.

Therefore, the aim of the study is to investigate the effect of additional neurodynamic intervention on the ankle range of motion, mechanosensitivity, balance performance and self-reported function.


Condition or disease Intervention/treatment Phase
Ankle Sprains Other: balance training alone Other: balance training and neurodynamic intervention for the common peroneal nerve Not Applicable

Detailed Description:

Approximately 40% of acute ankle sprain would develop into chronic ankle instability (CAI). Chronic ankle instability is characterized by pain, repeated sprains and giving way. Recently, the pathomechanical impairment, sensory-perceptual impairment and motor-behavioral impairment have been documented in the chronic ankle instability model. Previous research revealed that compared to the control subjects, people with CAI had lower pressure pain threshold (PPT). This increased mechanosensitivity of the neural tissues around the ankle might account for pain and dysfunction in people with CAI. Also, the other study indicated that in subjects following ankle inversion sprain there is greater restriction of knee extension on the injured side compared to non-injured side in the slump test with the ankle plantar flexion and inversion, which may suggest the restriction in mobility of the common peroneal tract. However, the effects of neurodynamic intervention, which addresses the mechanosensitivity problems, in people with CAI are still unclear.

Therefore, the aim of the study is to investigate the effect of additional neurodynamic intervention on the ankle range of motion, mechanosensitivity, balance performance and self-reported function.

The investigators will recruit 40 patients with chronic ankle instability and compare the effect of two intervention groups (balance training alone, combined balance training and neurodynamic intervention for the common peroneal nerve) on ankle range of motion (ROM), active knee ROM, pressure pain threshold , Y balance test and Foot and ankle ability measure (FAAM).

Independent test and Chi-square test are used to examine demographic data of the groups differences.

Two-way repeated measures ANOVA is used to examine the intervention effect with the alpha level set at 0.05

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effect of Additional Neurodynamic Intervention in Patients With Chronic Ankle Instability
Estimated Study Start Date : November 1, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Arm Intervention/treatment
Experimental: Experimental: balance training alone
The subjects will receive the balance training twice a week for 6 weeks.
Other: balance training alone

The subjects will warm up to stretch the lower extremity for 5 minutes.

The physical therapist will instruct the patient how to use the foot tripod within 5 minutes. And then, giving him or her balance training.

At the first, the patient double legs stand on the ground to throw and catch a ball for 30 seconds, and then one leg stand on the ground to throw and catch a ball for 30 seconds. When finished, the patient can take 1 minutes rest.

Second, the patient will finish the prescribed the task stand on different materials, which included the exercise mat, dynair, bosu and foam roller.


Experimental: Experimental: balance training and neurodynamic intervention for the common peroneal nerve
The subjects will receive the balance training and neurodynamic intervention for the common peroneal nerve twice a week for 6 weeks.
Other: balance training and neurodynamic intervention for the common peroneal nerve

The physical therapist will give the patient neurodynamic intervention for the common peroneal nerve, which is performed slider the nerve 2 seconds.

The slider technique is repeated 30 seconds for 4 times, each time can be take a rest 1 minutes.

The physical therapist will instruct the patient how to use the foot tripod within 5 minutes. And then, giving him or her balance training.

At the first, the patient double legs stand on the ground to throw and catch a ball for 30 seconds, and then one leg stand on the ground to throw and catch a ball for 30 seconds. When finished, the patient can take 1 minutes rest.

Second, the patient will finish the prescribed the task stand on different materials, which included the exercise mat, dynair, bosu and foam roller.





Primary Outcome Measures :
  1. Ankle range of motion [ Time Frame: pre-intervention ]

    Ask the person to face the wall and the tested foot in front, then the second toe and heel in the line is perpendicular to the wall. The contralateral limb is positioned behind the testing limb in a comfortable position and hands are placed on the wall in front to maintain stability. The gravity inclinometer is placed at the tibial tuberosity to measure the angle. The subjects will lunge forward trying to touch a vertical line on the wall with their knee, at the same time keeping heel contact with ground.

    Participants will perform three practice trials followed by 3 test trials and average the 3 tests.


  2. Ankle range of motion [ Time Frame: post 6 weeks intervention ]

    Ask the person to face the wall and the tested foot in front, then the second toe and heel in the line is perpendicular to the wall. The contralateral limb is positioned behind the testing limb in a comfortable position and hands are placed on the wall in front to maintain stability. The gravity inclinometer is placed at the tibial tuberosity to measure the angle. The subjects will lunge forward trying to touch a vertical line on the wall with their knee, at the same time keeping heel contact with ground.

    Participants will perform three practice trials followed by 3 test trials and average the 3 tests.


  3. Mechanosensitivity: Pain pressure threshold [ Time Frame: pre-intervention ]
    Using the plastic universal goniometer to measure the pain pressure threshold (PPT) of the anterior talofibular ligament, calcaneofibular ligament, peroneal nerve, peroneal longus muscle and peroneal brevis muscle. Measure a total of three times, and take a 30 seconds rest interval each time. In the end, the investigators will take average of the 3 tests.

  4. Mechanosensitivity: Pain pressure threshold [ Time Frame: post 6 weeks intervention ]
    Using the plastic universal goniometer to measure the pain pressure threshold (PPT) of the anterior talofibular ligament, calcaneofibular ligament, peroneal nerve, peroneal longus muscle and peroneal brevis muscle. Measure a total of three times, and take a 30 seconds rest interval each time. In the end, the investigators will take average of the 3 tests.

  5. Mechanosensitivity: Slump test with ankle plantar flexion and inversion to measure active knee range of motion [ Time Frame: pre-intervention ]

    The subjects sit on the edge of the bed without touching ground with their feet.

    The physical therapist assists the subjects to maintain the neutral pelvis position. First, ask the subjects flex the neck, trunk, and finally flex the lumbar to tighten the back. Second, while the subjects plantar and invert the ankle, participants will do the knee extension movement and record the angle of knee motion. Participants will perform three practice trials followed by 3 test trials and average the 3 tests.


  6. Mechanosensitivity: Slump test with ankle plantar flexion and inversion to measure active knee range of motion [ Time Frame: post 6 weeks intervention ]

    The subjects sit on the edge of the bed without touching ground with their feet.

    The physical therapist assists the subjects to maintain the neutral pelvis position. First, ask the subjects flex the neck, trunk, and finally flex the lumbar to tighten the back. Second, while the subjects plantar and invert the ankle, participants will do the knee extension movement and record the angle of knee motion. Participants will perform three practice trials followed by 3 test trials and average the 3 tests.


  7. Balance performance [ Time Frame: pre-intervention ]
    The subjects will stand on Y-balance kit and reach their legs alternatively to anterior, posterolateral and posteromedial direction with dominant leg first, in sequence. The subjects will practice 6 times first to familiarize the test procedure, then the final three measurements were collected and normalized with subject's lower limb length for statistical analysis.

  8. Balance performance [ Time Frame: post 6 weeks intervention ]
    The subjects will stand on Y-balance kit and reach their legs alternatively to anterior, posterolateral and posteromedial direction with dominant leg first, in sequence. The subjects will practice 6 times first to familiarize the test procedure, then the final three measurements were collected and normalized with subject's lower limb length for statistical analysis.

  9. Self-reported function: The Foot and Ankle Ability Measures (FAAM) [ Time Frame: pre-intervention ]
    The Foot and Ankle Ability Measures (FAAM) is a self-report measure that evaluate physical function of lower extremities musculoskeletal disorders. The measurement includes two parts, activities of daily living subscale of 21 items and sports subscale of 8 items. For each question, the subjects will chose the appropriate answer that most clearly describes their condition within the past week. It is based on the 4-0 scale. (4: no difficulty, 3: slight difficulty, 2: moderate difficulty, 1: extreme difficulty, 0: unable to do) If an activity in question is limited by something other than their foot or ankle, the patient is asked to record N/A. The sum of the scores in the two parts is less than ninety points, indicating that there is ankle instability

  10. Self-reported function: The Foot and Ankle Ability Measures (FAAM) [ Time Frame: post 6 weeks intervention ]
    The Foot and Ankle Ability Measures (FAAM) is a self-report measure that evaluate physical function of lower extremities musculoskeletal disorders. The measurement includes two parts, activities of daily living subscale of 21 items and sports subscale of 8 items. For each question, the subjects will chose the appropriate answer that most clearly describes their condition within the past week. It is based on the 4-0 scale. (4: no difficulty, 3: slight difficulty, 2: moderate difficulty, 1: extreme difficulty, 0: unable to do) If an activity in question is limited by something other than their foot or ankle, the patient is asked to record N/A. The sum of the scores in the two parts is less than ninety points, indicating that there is ankle instability



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. History of at least two ankle sprains in the same leg, of which the first sprain is more than one year
  2. Leading to at least one interrupted day of desired physical activity
  3. The Cumberland Ankle Instability Tool (CAIT) ≦ 24
  4. Slump test in ankle plantar flexion with inversion: positive

Exclusion Criteria:

  1. Pregnancy
  2. Surgical treatments
  3. Previous fractures in either lower extremity
  4. Any concomitant lower extremity pathology, for example, vascular disease, osteoarthritis and rheumatoid arthritis
  5. Significant pain or injury to the lumbar or cervical spine
  6. Regular use of medication: anti-inflammatory drugs, painkiller, steroid or muscle relaxants
  7. Previous manual therapy or exercise interventions received on the lower extremity within the previous 3 months
Layout table for additonal information
Responsible Party: Yi-Fen Shih, Professor, National Yang Ming University
ClinicalTrials.gov Identifier: NCT05090423    
Other Study ID Numbers: YM110112F
First Posted: October 22, 2021    Key Record Dates
Last Update Posted: October 22, 2021
Last Verified: October 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yi-Fen Shih, National Yang Ming University:
Chronic ankle instability
Neurodynamics
Mechanosensitivity
Additional relevant MeSH terms:
Layout table for MeSH terms
Ankle Injuries
Leg Injuries
Wounds and Injuries