Spinal Cord InjuriesNCT01740128
Multimodal Exercises to Improve Leg Function After Spinal Cord Injury
A study testing Robotic body weight supported treadmill training and Harness-supported multimodal balance training in people with Spinal Cord Injuries and Paraplegia, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Spinal Cord Injuries, Paraplegia, Paraparesis
- What is being tested?
- Robotic body weight supported treadmill training and Harness-supported multimodal balance training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2013to 23 Oct 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, 10468
About this study
Official title: A Hebbian Approach to Regaining Control of Spared Circuits in Spinal Cord Injury
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.
Read more
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
- Spinal Cord Injuries, Paraplegia, Paraparesis
- Being tested
- Robotic body weight supported treadmill training, Harness-supported multimodal balance training
- Keywords
- spinal cord injuries, paraplegia, postural balance, locomotor activity, exercise therapy, electromyography, transcranial magnetic stimulation, single pulse
- Medical subject headings
- Spinal Cord Injuries, Paraplegia, Paraparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic body weight supported treadmill trainingDevice
Also called Lokomat
30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.
Harness-supported multimodal balance trainingOther
Also called balance exercises, skilled hand exercises
30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal then Treadmill training | Experimental | 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. Receives: Device: Robotic body weight supported treadmill training; Other: Harness-supported multimodal balance training |
| Treadmill then Multimodal training | Active comparator | 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. Receives: Device: Robotic body weight supported treadmill training; Other: Harness-supported multimodal balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study start1 Jan 2013
- Primary completion30 Nov 2016
- Study completion23 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Noam Y Harel, MD PhD, Principal investigator, James J. Peters Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01740128
- Sponsor's protocol ID
- B0881-W
- Other IDs
- 5IK2RX000881-03, 01407, SPU-11-077
- Status last verified
- Jan 2018
- First submitted
- 30 Nov 2012
- Last updated
- 26 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
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 23809527Harel 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Hebbian Approach to Regaining Control of Spared Circuits in Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT01740128
- Acronym / sponsor ID
- B0881-W
- Conditions
- Spinal Cord Injuries, Paraplegia, Paraparesis
- Keywords
- spinal cord injuries, paraplegia, postural balance, locomotor activity, exercise therapy, electromyography, transcranial magnetic stimulation, single pulse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 23 Oct 2017 (actual)
- First posted
- 4 Dec 2012 (estimated)
- Results
- Posted 26 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal then Treadmill training | Experimental | Device: Robotic body weight supported treadmill training, Other: Harness-supported multimodal balance trainingParticipants 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. |
| Treadmill then Multimodal training | Active comparator | Device: Robotic body weight supported treadmill training, Other: Harness-supported multimodal balance trainingRobotic 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic body weight supported treadmill trainingAlso: Lokomat30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks. | Device | Multimodal then Treadmill training, Treadmill then Multimodal training |
| Harness-supported multimodal balance trainingAlso: balance exercises, skilled hand exercises30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks. | Other | Multimodal then Treadmill training, Treadmill then Multimodal training |
Primary outcome
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.
10 secondary outcomes
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 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 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 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 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 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 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 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)
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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23809527Harel 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.
- Background: PubMed 25771437Harel 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noam Y Harel, MD PhD principal investigator
James J. Peters Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic body weight supported treadmill training and Harness-supported multimodal balance training in people with Spinal Cord Injuries and Paraplegia, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01740128, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2018.