search
Back to results

Multimodal Exercises to Improve Leg Function After Spinal Cord Injury

Primary Purpose

Spinal Cord Injuries, Paraplegia, Paraparesis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Robotic body weight supported treadmill training
Harness-supported multimodal balance training
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring spinal cord injuries, paraplegia, postural balance, locomotor activity, exercise therapy, electromyography, transcranial magnetic stimulation, single pulse

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • James J. Peters VA Medical Center, Bronx, NY

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Multimodal then Treadmill training

Treadmill then Multimodal training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Motor Evoked Potential (MEP) Amplitude in the Tibialis Anterior Muscle at the End of Training.
Change between baseline and Evaluation #2 in motor evoked potential area in the tibialis anterior muscle.

Secondary Outcome Measures

Change From Baseline in ISNCSCI Lower Extremity Motor Score.
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.
Change between baseline and Evaluation #2 in Berg sitting unsupported subscore. Range 0-4, higher better.
Change in Leg Spasticity on Modified Ashworth Scale
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.
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.
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.
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).
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.
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.
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)
Change between baseline and Evaluation #2 in SCI-SET score. Range of scores -105 to +105. Higher is better.

Full Information

First Posted
November 30, 2012
Last Updated
January 26, 2018
Sponsor
VA Office of Research and Development
search

1. Study Identification

Unique Protocol Identification Number
NCT01740128
Brief Title
Multimodal Exercises to Improve Leg Function After Spinal Cord Injury
Official Title
A Hebbian Approach to Regaining Control of Spared Circuits in Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2013 (Actual)
Primary Completion Date
November 30, 2016 (Actual)
Study Completion Date
October 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Paraplegia, Paraparesis
Keywords
spinal cord injuries, paraplegia, postural balance, locomotor activity, exercise therapy, electromyography, transcranial magnetic stimulation, single pulse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multimodal then Treadmill training
Arm Type
Experimental
Arm Description
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.
Arm Title
Treadmill then Multimodal training
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Robotic body weight supported treadmill training
Other Intervention Name(s)
Lokomat
Intervention Description
30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.
Intervention Type
Other
Intervention Name(s)
Harness-supported multimodal balance training
Other Intervention Name(s)
balance exercises, skilled hand exercises
Intervention Description
30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.
Primary Outcome Measure Information:
Title
Change in Motor Evoked Potential (MEP) Amplitude in the Tibialis Anterior Muscle at the End of Training.
Description
Change between baseline and Evaluation #2 in motor evoked potential area in the tibialis anterior muscle.
Time Frame
Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Secondary Outcome Measure Information:
Title
Change From Baseline in ISNCSCI Lower Extremity Motor Score.
Description
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.
Time Frame
Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Title
Change From Baseline in Berg Balance Scale Sitting With Back Unsupported Score.
Description
Change between baseline and Evaluation #2 in Berg sitting unsupported subscore. Range 0-4, higher better.
Time Frame
Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Title
Change in Leg Spasticity on Modified Ashworth Scale
Description
Change between baseline and Evaluation #2 in modified Ashworth Scale. 0-4 score, lower is better.
Time Frame
Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Title
Change in Gait Speed on 10-meter Walk Test.
Description
Change between baseline and Evaluation #2 in gait speed during 10-meter walk test.
Time Frame
Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Title
Change From Baseline in Walking Index for Spinal Cord Injury II (WISCI II) Scale.
Description
Change between baseline and Evaluation #2 in WISCI II score. Scores range 0-20, higher is better.
Time Frame
Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Title
Change From Baseline in Total Number of Steps Taken by Both Feet During Seated 10-second Step Test.
Description
Change between baseline and Evaluation #2 in steps taken during 10-second step test.
Time Frame
Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Title
Change in Subjective Pain as Determined by McGill Pain Questionnaire (Short Form).
Description
Change between baseline and Evaluation #2 in McGill Pain Questionnaire (Subjective Domain). Total scale 0-45, lower is better.
Time Frame
Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Title
Change From Baseline in Endpoint Excursion and Directional Control Parameters Achieved During Seated Limits of Stability Testing.
Description
Seated posturography performed using the "Limits of Stability" module of the Smart EquiTest apparatus (Neurocom) while seated. Directional Control measure.
Time Frame
Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Title
Change From Baseline in Soleus H-reflex Facilitation.
Description
Change between baseline and Evaluation #2 in soleus H-reflex facilitation by transcranial magnetic stimulation (TMS). Short-interval 0-20ms.
Time Frame
Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Title
Changes From Baseline in Survey: Spinal Cord Injury - Spasticity Evaluation Tool (SCI-SET)
Description
Change between baseline and Evaluation #2 in SCI-SET score. Range of scores -105 to +105. Higher is better.
Time Frame
Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noam Y Harel, MD PhD
Organizational Affiliation
James J. Peters Veterans Affairs Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
James J. Peters VA Medical Center, Bronx, NY
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
23809527
Citation
Harel NY, Asselin PK, Fineberg DB, Pisano TJ, Bauman WA, Spungen AM. Adaptation of computerized posturography to assess seated balance in persons with spinal cord injury. J Spinal Cord Med. 2013 Mar;36(2):127-33. doi: 10.1179/2045772312Y.0000000053.
Results Reference
background
PubMed Identifier
25771437
Citation
Harel NY, Martinez SA, Knezevic S, Asselin PK, Spungen AM. Acute changes in soleus H-reflex facilitation and central motor conduction after targeted physical exercises. J Electromyogr Kinesiol. 2015 Jun;25(3):438-43. doi: 10.1016/j.jelekin.2015.02.009. Epub 2015 Mar 2.
Results Reference
background

Learn more about this trial

Multimodal Exercises to Improve Leg Function After Spinal Cord Injury

We'll reach out to this number within 24 hrs