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| ID | Type | Description | Link |
|---|---|---|---|
| 5IK2RX000881-03 | U.S. NIH Grant/Contract | View source | |
| 01407 | Other Identifier | Bronx VA Medical Center | |
| SPU-11-077 | Other Identifier | Bronx VA Medical Center |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic body weight supported treadmill training | Device | 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Noam Y Harel, MD PhD | James J. Peters Veterans Affairs Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James J. Peters VA Medical Center, Bronx, NY | The Bronx | New York | 10468 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23809527 | Background | 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. | |
| 25771437 | Background | 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. |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks. |
| FG001 | Treadmill Then Multimodal Training | Participants will undergo body weight supported treadmill training using the Lokomat apparatus. Following a washout period of at least 6 weeks, Participants will undergo harness-supported multimodal balance training exercises while simultaneously performing skilled hand exercises. 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Only two participants in the study had consistent MEPs at baseline. | Posted | Number | Amplitude percentage of Mmax | Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months) |
|
Approx. 6 months or until completion of study participation.
No serious adverse events. Several minor skin abrasions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Multimodal Training | Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises. Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| skin abrasion | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
Smaller than expected enrollment, high dropout rate.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Noam Y. Harel, MD, PhD | James J. Peters VAMC | 718-584-9000 | 1742 | noam.harel@va.gov |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D010264 | Paraplegia |
| D020335 | Paraparesis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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|
| Harness-supported multimodal balance training | Other | 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks. |
|
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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: 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: 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. | Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months) |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Insufficient protocol compliance |
|
| BG001 | 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. Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks. 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Robotic body weight supported treadmill training will be applied using the Lokomat apparatus. 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. |
|
|
| Secondary | 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. | One subject in multimodal group failed to appear for post-intervention testing for this outcome. | Posted | Mean | Standard Deviation | units on a scale | Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months) |
|
|
|
| Secondary | 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. | Incomplete analysis due to dropouts before post-testing | Posted | Mean | Standard Deviation | units on a scale | Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months) |
|
|
|
| Secondary | Change in Leg Spasticity on Modified Ashworth Scale | Change between baseline and Evaluation #2 in modified Ashworth Scale. 0-4 score, lower is better. | Incomplete analysis due to dropouts before post-testing, and due to incomplete outcome assessment by Investigating team. | Posted | Mean | Standard Deviation | units on a scale | Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months) |
|
|
|
| Secondary | Change in Gait Speed on 10-meter Walk Test. | Change between baseline and Evaluation #2 in gait speed during 10-meter walk test. | Insufficient number of participants able to walk at baseline. | Posted | Mean | Standard Deviation | meters per second | Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months) |
|
|
|
| Secondary | 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. | Insufficient number of participants able to walk at baseline. Measure not recorded by Investigating team. | Posted | Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months) |
|
|
| Secondary | 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. | Low number of participants able to perform seated steps at baseline. | Posted | Mean | Standard Error | steps | Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months) |
|
|
|
| Secondary | 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. | Incomplete analysis due to dropouts before post-testing, and due to incomplete outcome assessment by Investigating team. | Posted | Mean | Standard Deviation | units on a scale | Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months) |
|
|
|
| Secondary | 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. | Incomplete analysis due to dropouts before post-testing. | Posted | Mean | Standard Error | Percentage of perfect path to target | Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months) |
|
|
|
| Secondary | 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. | Incomplete analysis due to dropouts before post-testing, and due to lack of soleus H-reflex in several subjects. | Posted | Mean | Standard Error | percentage of control reflex size | Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months) |
|
|
|
| Secondary | 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. | Incomplete analysis due to dropouts before post-testing, and due to incomplete outcome assessment by Investigating team. | Posted | Mean | Standard Deviation | units on a scale | Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months) |
|
|
|
| 0 |
| 10 |
| 1 |
| 10 |
| EG001 | Treadmill Training | Robotic body weight supported treadmill training will be applied using the Lokomat apparatus. 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. | 0 | 11 | 3 | 11 |
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| D014947 | Wounds and Injuries |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010291 | Paresis |