CompletedNCT01740128Updated Feb 26, 2018Results posted

Multimodal Exercises to Improve Leg Function After Spinal Cord Injury

An interventional study of Robotic body weight supported treadmill training and Harness-supported multimodal balance training in Spinal Cord Injuries, Paraplegia and Paraparesis, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-02-26.

Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 21
Allocation: Randomized
Ages: 21 Years to 65 Years
Sex: All

Study 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.

Conditions studied

Spinal Cord Injuries
Paraplegia
Paraparesis

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Keywords

spinal cord injuries
paraplegia
postural balance
locomotor activity
exercise therapy
electromyography
transcranial magnetic stimulation, single pulse

In context

Spinal Cord Injuries

1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.

This study's enrollment of 21 is below the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.

Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 21 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Single (Outcomes assessor)
Enrollment: 21 participants (actual)

Study arms

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.
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.
Device: Robotic body weight supported treadmill training · Other: Harness-supported multimodal balance training

Interventions

DeviceRobotic 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.
Also known as: Lokomat
OtherHarness-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.
Also known as: balance exercises, skilled hand exercises

What researchers measure

Primary outcomes

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.
Time frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)

Secondary outcomes

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.
Time frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
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.
Time frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Change in Leg Spasticity on Modified Ashworth Scale
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)
Change in Gait Speed on 10-meter Walk Test.
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)
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.
Time frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
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.
Time frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
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.
Time frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
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.
Time frame: Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
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.
Time frame: Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
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.
Time frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)

Results

Posted Feb 26, 2018

Limitations and caveats

Smaller than expected enrollment, high dropout rate.

Participant flow

Participant flow — Overall Study
Milestone	Multimodal Then Treadmill Training	Treadmill Then Multimodal Training
Started	10	11
Completed	4	4
Not completed	6	7
Withdrew: Pregnancy	0	1
Withdrew: Protocol violation	1	2
Withdrew: Lost to follow-up	2	2
Withdrew: Withdrawal by subject	1	0
Withdrew: Insufficient protocol compliance	2	2

Outcome measures

PrimaryChange 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.

Time frame:: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Reported as:: Number · Amplitude percentage of Mmax

Change in Motor Evoked Potential (MEP) Amplitude in the Tibialis Anterior Muscle at the End of Training.
Amplitude percentage of Mmax	Multimodal Training	Treadmill Training
Change in Motor Evoked Potential (MEP) Amplitude in the Tibialis Anterior Muscle at the End of Training.	-1.75	-2.01

SecondaryChange 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.

Time frame:: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Reported as:: Mean · units on a scale

Change From Baseline in ISNCSCI Lower Extremity Motor Score.
units on a scale	Multimodal Training	Treadmill Training
Change From Baseline in ISNCSCI Lower Extremity Motor Score.	0.11 ± 4.81	-0.30 ± 4.32

SecondaryChange 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.

Time frame:: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Reported as:: Mean · units on a scale

Change From Baseline in Berg Balance Scale Sitting With Back Unsupported Score.
units on a scale	Multimodal Training	Treadmill Training
Change From Baseline in Berg Balance Scale Sitting With Back Unsupported Score.	0.10 ± 0.32	0.00 ± 0.00

SecondaryChange in Leg Spasticity on Modified Ashworth Scale

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)
Reported as:: Mean · units on a scale

Change in Leg Spasticity on Modified Ashworth Scale
units on a scale	Multimodal Training	Treadmill Training
Change in Leg Spasticity on Modified Ashworth Scale	0.13 ± 0.25	-0.39 ± 0.89

SecondaryChange in Gait Speed on 10-meter Walk Test.

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)
Reported as:: Mean · meters per second

Change in Gait Speed on 10-meter Walk Test.
meters per second	Multimodal Training	Treadmill Training
Change in Gait Speed on 10-meter Walk Test.	.04 ± 0	0.12 ± 0.132

SecondaryChange 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.

Time frame:: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)

No measurements were reported for this outcome.

SecondaryChange 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.

Time frame:: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Reported as:: Mean · steps

Change From Baseline in Total Number of Steps Taken by Both Feet During Seated 10-second Step Test.
steps	Multimodal Training	Treadmill Training
Change From Baseline in Total Number of Steps Taken by Both Feet During Seated 10-second Step Test.	2.83 ± 1.14	-1.08 ± 1.03

SecondaryChange 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.

Time frame:: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Reported as:: Mean · units on a scale

Change in Subjective Pain as Determined by McGill Pain Questionnaire (Short Form).
units on a scale	Multimodal Training	Treadmill Training
Change in Subjective Pain as Determined by McGill Pain Questionnaire (Short Form).	0.89 ± 2.76	-0.93 ± 3.00

SecondaryChange 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.

Time frame:: Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Reported as:: Mean · Percentage of perfect path to target

Change From Baseline in Endpoint Excursion and Directional Control Parameters Achieved During Seated Limits of Stability Testing.
Percentage of perfect path to target	Multimodal Training	Treadmill Training
Change From Baseline in Endpoint Excursion and Directional Control Parameters Achieved During Seated Limits of Stability Testing.	1.93 ± 3.42	8.42 ± 4.02

SecondaryChange 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.

Time frame:: Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Reported as:: Mean · percentage of control reflex size

Change From Baseline in Soleus H-reflex Facilitation.
percentage of control reflex size	Multimodal Training	Treadmill Training
Change From Baseline in Soleus H-reflex Facilitation.	6.63 ± 6.25	-5.20 ± 3.35

SecondaryChanges 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.

Time frame:: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Reported as:: Mean · units on a scale

Changes From Baseline in Survey: Spinal Cord Injury - Spasticity Evaluation Tool (SCI-SET)
units on a scale	Multimodal Training	Treadmill Training
Changes From Baseline in Survey: Spinal Cord Injury - Spasticity Evaluation Tool (SCI-SET)	2.14 ± 11.44	-0.67 ± 0.82

Adverse events

Collected over Approx. 6 months or until completion of study participation.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Multimodal Training	—	0/10 (0%)	1/10 (10%)
Treadmill Training	—	0/11 (0%)	3/11 (27.3%)

Most frequent other events

Most frequent other events
Event	Multimodal Training	Treadmill Training
skin abrasionSkin and subcutaneous tissue disorders	1/10	3/11

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Multimodal Then Treadmill Training	Treadmill Then Multimodal Training	Total
<=18 years	0	0	0
Between 18 and 65 years	10	11	21
>=65 years	0	0	0

Sex: Female, Male
Sex: Female, Male(Participants)	Multimodal Then Treadmill Training	Treadmill Then Multimodal Training	Total
Female	3	2	5
Male	7	9	16

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Multimodal Then Treadmill Training	Treadmill Then Multimodal Training	Total
American Indian or Alaska Native	0	0	0
Asian	0	1	1
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	3	6	9
White	6	3	9
More than one race	0	0	0
Unknown or Not Reported	1	1	2

Region of Enrollment
Region of Enrollment(Participants)	Multimodal Then Treadmill Training	Treadmill Then Multimodal Training	Total
United States	10	11	21

Study locations

1 site

James J. Peters VA Medical Center, Bronx, NY
Bronx, New York 10468, United States

References and documents

Publications

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. PubMed 23809527 ↗
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. PubMed 25771437 ↗

Individual participant data

Plan to share: Yes — 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.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 26, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01740128
Lead sponsor: VA Office of Research and Development
Responsible party: Sponsor
First posted: Dec 4, 2012
Start date: Jan 1, 2013
Primary completion: Nov 30, 2016
Completion: Oct 23, 2017
Results posted: Feb 26, 2018
Last update: Feb 26, 2018

Study contacts

Noam Y Harel, MD PhD

principal investigator · James J. Peters Veterans Affairs Medical Center

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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