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Multimodal Exercises to Improve Leg Function After Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT01740128
Recruitment Status : Completed
First Posted : December 4, 2012
Results First Posted : February 26, 2018
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE November 30, 2012
First Posted Date  ICMJE December 4, 2012
Results First Submitted Date  ICMJE November 16, 2017
Results First Posted Date  ICMJE February 26, 2018
Last Update Posted Date February 26, 2018
Actual Study Start Date  ICMJE January 1, 2013
Actual Primary Completion Date November 30, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2018)
Change in Motor Evoked Potential (MEP) Amplitude in the Tibialis Anterior Muscle at the End of Training. [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months) ]
Change between baseline and Evaluation #2 in motor evoked potential area in the tibialis anterior muscle.
Original Primary Outcome Measures  ICMJE
 (submitted: November 30, 2012)
Change in motor evoked potential (MEP) area in the tibialis anterior muscle at the end of training. [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions); Eval #3 at 6-week follow-up ]
Change between baseline and Evaluation #2 in motor evoked potential area in the tibialis anterior muscle.
Change History Complete list of historical versions of study NCT01740128 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2018)
  • Change From Baseline in ISNCSCI Lower Extremity Motor Score. [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months) ]
    Change between baseline and Evaluation #2 in lower extremity motor score derived from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI). Range of scores 0-50, higher is better.
  • Change From Baseline in Berg Balance Scale Sitting With Back Unsupported Score. [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months) ]
    Change between baseline and Evaluation #2 in Berg sitting unsupported subscore. Range 0-4, higher better.
  • Change in Leg Spasticity on Modified Ashworth Scale [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months) ]
    Change between baseline and Evaluation #2 in modified Ashworth Scale. 0-4 score, lower is better.
  • Change in Gait Speed on 10-meter Walk Test. [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months) ]
    Change between baseline and Evaluation #2 in gait speed during 10-meter walk test.
  • Change From Baseline in Walking Index for Spinal Cord Injury II (WISCI II) Scale. [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months) ]
    Change between baseline and Evaluation #2 in WISCI II score. Scores range 0-20, higher is better.
  • Change From Baseline in Total Number of Steps Taken by Both Feet During Seated 10-second Step Test. [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months) ]
    Change between baseline and Evaluation #2 in steps taken during 10-second step test.
  • Change in Subjective Pain as Determined by McGill Pain Questionnaire (Short Form). [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months) ]
    Change between baseline and Evaluation #2 in McGill Pain Questionnaire (Subjective Domain). Total scale 0-45, lower is better.
  • Change From Baseline in Endpoint Excursion and Directional Control Parameters Achieved During Seated Limits of Stability Testing. [ Time Frame: Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months) ]
    Seated posturography performed using the "Limits of Stability" module of the Smart EquiTest apparatus (Neurocom) while seated. Directional Control measure.
  • Change From Baseline in Soleus H-reflex Facilitation. [ Time Frame: Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months) ]
    Change between baseline and Evaluation #2 in soleus H-reflex facilitation by transcranial magnetic stimulation (TMS). Short-interval 0-20ms.
  • Changes From Baseline in Survey: Spinal Cord Injury - Spasticity Evaluation Tool (SCI-SET) [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months) ]
    Change between baseline and Evaluation #2 in SCI-SET score. Range of scores -105 to +105. Higher is better.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2012)
  • Change from baseline in ASIA Impairment Scale (AIS) sensory scores. [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions); Eval #3 at 6-week follow-up ]
  • Change from baseline in AIS lower extremity motor score. [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions); Eval #3 at 6-week follow-up ]
  • Change From Baseline in Berg Balance Scale Sitting With Back Unsupported Score. [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions); Eval #3 at 6-week follow-up ]
  • Change in Leg Spasticity on Modified Ashworth Scale [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions); Eval #3 at 6-week follow-up ]
  • Change in Gait Speed on 10-meter Walk Test. [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions); Eval #3 at 6-week follow-up ]
  • Change From Baseline in Walking Index for Spinal Cord Injury II (WISCI II) Scale. [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions); Eval #3 at 6-week follow-up ]
  • Change From Baseline in Total Number of Steps Taken by Both Feet During Seated 10-second Step Test. [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions); Eval #3 at 6-week follow-up ]
  • Change in Subjective Pain as Determined by McGill Pain Questionnaire (Short Form). [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions); Eval #3 at 6-week follow-up ]
  • Change From Baseline in Endpoint Excursion and Directional Control Parameters Achieved During Seated Limits of Stability Testing. [ Time Frame: Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions); Eval #3 at 6-week follow-up ]
    Seated posturography performed using Smart EquiTest apparatus (Neurocom).
  • Change From Baseline in Soleus H-reflex Facilitation. [ Time Frame: Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions); Eval #3 at 6-week follow-up ]
  • Change from baseline in the Voluntary Response Index (VRI) for key leg muscles as detected by surface electromyography (Lee et al., 2004). [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions); Eval #3 at 6-week follow-up ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multimodal Exercises to Improve Leg Function After Spinal Cord Injury
Official Title  ICMJE A Hebbian Approach to Regaining Control of Spared Circuits in Spinal Cord Injury
Brief Summary

Many people with spinal cord injury (SCI) retain at least some movement below their injury, but their muscles often have a 'mind of their own'. Typical exercise programs focus on keeping muscles strong and flexible, but don't usually focus on helping patients control their muscles. The investigators' exercise research study will compare two different programs with the specific goal of improving conscious control of patients' muscles below the injury. This study focuses on those with 'chronic' SCI - the injury occurred at least one year prior to enrolling.

This is a single center study taking place in the Bronx, NY.

The first phase of the study will be observational - the investigators will analyze which nerve connections might remain partially intact through the injury (even if the nerves aren't consciously controlled). Participants with all severity of SCI may participate in this first phase.

The second phase of the study will involve people who retain at least slight ability to move their legs and the ability to move the arms against gravity. Each person will undergo two different exercise rehabilitation strategies: weight-supported treadmill training; and balance training combined with skilled arm or hand exercises.

The investigators will compare the effects of these exercise programs on a variety of outcomes, including gait speed, balance, strength, and muscle activation in response to brain stimulation.

The investigators hypothesize that participants with chronic SCI undergoing combined balance/arm/hand training will show improved outcomes when compared to traditional gait or balance training.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Spinal Cord Injuries
  • Paraplegia
  • Paraparesis
Intervention  ICMJE
  • Device: Robotic body weight supported treadmill training
    30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.
    Other Name: Lokomat
  • Other: Harness-supported multimodal balance training
    30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.
    Other Name: balance exercises, skilled hand exercises
Study Arms  ICMJE
  • Experimental: Multimodal then Treadmill training
    Participants will undergo harness-supported multimodal balance training exercises while simultaneously performing skilled hand exercises. Following a washout period of at least 6 weeks, Participants will undergo body weight supported treadmill training using the Lokomat apparatus.
    Interventions:
    • Device: Robotic body weight supported treadmill training
    • Other: Harness-supported multimodal balance training
  • Active Comparator: Treadmill then Multimodal training
    Robotic body weight supported treadmill training will be applied using the Lokomat apparatus. Following a washout period of at least 6 weeks, Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.
    Interventions:
    • Device: Robotic body weight supported treadmill training
    • Other: Harness-supported multimodal balance training
Publications *

*   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 26, 2018)
21
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2012)
75
Actual Study Completion Date  ICMJE October 23, 2017
Actual Primary Completion Date November 30, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males or females age 21-65 years;
  • SCI duration > 12 months;
  • SCI level C2-T12;
  • All SCI severity eligible for baseline testing;
  • For exercise protocol, must have severity of Grade C or D on American Spinal Injury Association (ASIA) Impairment Scale, or volitional strength of at least 1/5 in two or more key lower extremity muscles, as well as at least 3/5 in both shoulder and elbow muscles;
  • Able to tolerate upright position with support;
  • Morphologically capable of fitting a weight-support harness and robotic treadmill system;
  • Ability to give informed consent.

Exclusion Criteria:

  • Unsuitable cognitive capacity as judged by the study physician;
  • Diagnosis of neurological injury other than SCI, such as stroke, traumatic brain injury, or other neurological condition that the study physician considers to be exclusionary;
  • Multiple spinal cord lesions;
  • History of frequent autonomic dysreflexia;
  • History of seizures;
  • Use of medications that significantly lower seizure threshold, such as anti-psychotics, tricyclic antidepressants, amphetamines, and bupropion;
  • History of implanted brain/spine/nerve stimulators, aneurysm clips, or cardiac pacemaker/defibrillator;
  • Deep vein thrombosis in lower extremities of less than 6 months duration;
  • Pregnancy;
  • (Interventional phase only): Lack of detectable tibialis anterior motor evoked potential (MEP) at baseline even with active facilitation;
  • (Interventional phase only): Pressure ulcers greater than stage 1 severity on the foot, ankle, knee and/or pelvic girdle;
  • (Interventional phase only): Bone mineral density of the hip (proximal femur) T-score <3.5 standard deviations from age- and gender-matched normative data;
  • (Interventional phase only): Any spasticity, contractures, or heterotopic ossification that result in inadequate range of motion of the shoulder, elbow, wrist, fingers, hip, knee, or ankle joints in the judgment of the study physician;
  • (Interventional phase only): Inability to cooperate with instructions or unwilling to commit to daily training sessions for 3-4 days per week over 12-16 weeks;
  • (Interventional phase only): A diagnosis of coronary artery disease that precludes moderate to intense exercise.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older 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 NCT01740128
Other Study ID Numbers  ICMJE B0881-W
IK2RX000881-03 ( U.S. NIH Grant/Contract )" onClick="openNewWindow('https://projectreporter.nih.gov/reporterapi.cfm?PROJECTNUM=5IK2RX000881-03&Fy=all'); return false">5IK2RX000881-03 ( U.S. NIH Grant/Contract )
01407 ( Other Identifier: Bronx VA Medical Center )
SPU-11-077 ( Other Identifier: Bronx VA Medical Center )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: A Limited Dataset (LDS) will be shared in electronic format pursuant to a VA-approved Data Use Agreement. Individually Identifiable Data will be shared pursuant to valid HIPAA Authorization, Informed Consent, and an appropriate written agreement limiting use of the data to the conditions as described in the authorization and consent, and a written assurance from the recipient that the information will be maintained in accordance with the security requirements of 38 CFR Part 1.466.
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Noam Y Harel, MD PhD James J. Peters Veterans Affairs Medical Center
PRS Account VA Office of Research and Development
Verification Date January 2018

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