Dosing of Overground Robotic Gait Training With Functional Outcomes and Neuroplasticity After Spinal Cord Injury

Study Overview
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Brief Summary
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The DOOR SCI project examines dosing effects of robotic gait training (RGT) and transcranial magnetic stimulation (TMS) initiated during inpatient rehabilitation and continued through early outpatient rehabilitation

Detailed Description
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Emerging evidence indicates that robotic exoskeleton use results in positive outcomes for those with chronic SCI, yet limited evidence exists for the acute setting. The potential benefit of RGT initiated during inpatient rehabilitation when recovery is greatest is unknown yet appears promising due to established principles of neuroplasticity and the fact that RGT incorporates the critical components of gait training. As a result of the lack of evidence, no clinical practice guidelines exist that delineate which gait retraining approach or dose during early phases of recovery results in the best outcomes for people with motor incomplete SCI. The DOOR SCI project examines dosing effects on 5 occasions over 9 months: (1) inpatient rehabilitation admission and (2) discharge, (3) after completing 24 RGT sessions, (4) 1-month post RGT, and (5) 9-months post SCI). To test the overarching goal, investigators propose three specific aims: Aim 1: Using a randomized controlled trial, prospectively examine whether the dosing frequency [24 sessions delivered as high, moderate, or low frequency, defined by number days/week (4, 3, or 2 days/week over 6, 8, 12 weeks)] of RGT therapy provided during the acute/subacute recovery phase after motor incomplete SCI impacts outcomes. Aim 2: Investigate the difference over 9 months of the neuroplastic effect of RGT dosing as measured by single pulse TMS. Aim 3: Evaluate the safety, tolerability, and feasibility of delivering different dosing frequencies of RGT from inpatient to outpatient rehabilitation settings.

Official Title
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Dosing of Overground Robotic Gait Training With Functional Outcomes and Neuroplasticity After Spinal Cord Injury

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Device: Robotic Gait Training
* Other: Usual Care (UC) Gait Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All types of motor incomplete SCI (traumatic and non-traumatic) Acute/Subacute phase of recovery Medically stable as deemed by physician Undergoing medical care and rehabilitation at Baylor Scott & White Institute for Rehabilitation Both genders and all races and ethnicities Meet the Ekso robotic exoskeleton frame limitations Continence of or a program for bladder and bowel management Exclusion Criteria: Concurrent moderate to severe traumatic brain injury (TBI) Degenerative diagnoses Pre-morbid developmental disability, significant psychological diagnosis, or other cognitive impairment Primary residence >90 miles away from Baylor Scott & White Institute for Rehabilitation Pregnancy

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be randomly assigned into one of 4 gait training groups: usual care (UC) gait training only; high frequency RGT - 4 sessions/week for 6 weeks; moderate frequency RGT - 3 sessions/week for 8 weeks; or low frequency RGT - 2 sessions/week for 12 weeks
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Frequency<br>Subjects will receive 2 sessions of robotic gait training (RGT) per week for 12 weeks | Device: Robotic Gait Training<br>* Subjects will be randomized to one of 4 gait training group. The duration of treatment will span across their inpatient rehabilitation length of stay after providing informed consent to their 9 months post-SCI visit in the outpatient rehabilitation setting. Subjects will wear an exoskeleton device and receive robotic gait training (RGT) with a physical therapist during a 45-minutes inpatient rehabilitation session. Subjects will complete 24 robotic gait training sessions over different durations during outpatient rehabilitation. Subjects will also complete a transcranial magnetic stimulation (TMS) assessment and questionnaires about walking and function. Subjects will be asked to wear an activity monitor to measure their activity.<br>* Other names: Ekso GT™ robotic exoskeleton;|
| Experimental: Moderate Frequency<br>Subjects will receive 3 sessions of robotic gait training (RGT) per week for 8 weeks | Device: Robotic Gait Training<br>* Subjects will be randomized to one of 4 gait training group. The duration of treatment will span across their inpatient rehabilitation length of stay after providing informed consent to their 9 months post-SCI visit in the outpatient rehabilitation setting. Subjects will wear an exoskeleton device and receive robotic gait training (RGT) with a physical therapist during a 45-minutes inpatient rehabilitation session. Subjects will complete 24 robotic gait training sessions over different durations during outpatient rehabilitation. Subjects will also complete a transcranial magnetic stimulation (TMS) assessment and questionnaires about walking and function. Subjects will be asked to wear an activity monitor to measure their activity.<br>* Other names: Ekso GT™ robotic exoskeleton;|
| Experimental: High Frequency<br>Subjects will receive 4 sessions of robotic gait training (RGT) per week for 6 weeks | Device: Robotic Gait Training<br>* Subjects will be randomized to one of 4 gait training group. The duration of treatment will span across their inpatient rehabilitation length of stay after providing informed consent to their 9 months post-SCI visit in the outpatient rehabilitation setting. Subjects will wear an exoskeleton device and receive robotic gait training (RGT) with a physical therapist during a 45-minutes inpatient rehabilitation session. Subjects will complete 24 robotic gait training sessions over different durations during outpatient rehabilitation. Subjects will also complete a transcranial magnetic stimulation (TMS) assessment and questionnaires about walking and function. Subjects will be asked to wear an activity monitor to measure their activity.<br>* Other names: Ekso GT™ robotic exoskeleton;|
| Active Comparator: Control Group<br>Subjects will receive usual care gait training without robotic gait training | Other: Usual Care (UC) Gait Training<br>* Subjects will be randomized to one of 4 gait training group. The duration of treatment will span across their inpatient rehabilitation length of stay after providing informed consent to their 9 months post-SCI visit in the outpatient rehabilitation setting. Subjects will complete gait training with a physical therapist during a 45-minutes inpatient rehabilitation session. Subjects will also complete a transcranial magnetic stimulation (TMS) assessment and questionnaires about walking and function. Subjects will be asked to wear an activity monitor to measure their activity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Walking Index for Spinal Cord Injury - II (WISCI-II) from baseline | The WISCI-II defines the physical limitation for gait secondary to impairment at the person level and indicates the ability of a person to walk after SCI. The WISC-II rank orders the ability a person to walk on a scale of 0-20 with 0 representing no ability to stand or participate in assisted walking and 20 representing an ability to walk 10 meters with no devices, no braces, and no physical assistance. | Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 10-Meter Walk Test (10MWT) | The 10MWT assesses gait speed (m/s) over a short duration. | Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset | 
| Change in Spinal Cord Independence Measure (SCIM) | The SCIM assesses the ability of a person with spinal cord injury (SCI) to preform specified tasks independently, with assistance, or with assistive devices. SCIM is composed of 19 items with total SCIM scores ranging from 0 (required assistance) to 100 (independence). A higher score means greater independence. | Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset | 
| Change in Numerical Pain Rating Scale (NPRS) | Pain is a significant problem in many individuals with SCI. A 0-10 Point Numerical Pain Rating Scale (NRS) is recommended as the outcome measure for pain intensity after SCI during acute and subacute phases. Pain severity can be categorized into 3 distinct groups as relates to pain interference: 1-3 (mild), 4-7 (moderate), 8-10 (severe). A higher score means greater pain severity. | Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset | 
| Change in Fatigue Severity Scale (FSS) | The Fatigue Severity Scale (FSS) is used to measure fatigue in neurologic disorders and measures the effects of fatigue on function. It is measure on the following scale: - Strongly Disagree - Disagree - Slightly Disagree - Neutral - Slightly Agree - Agree - Strongly Agree A higher score means greater fatigue. | Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset | 
| Change in Penn Spasm Frequency Scale (PSFS) | The PSFS is a self-report measure to assess a patient's perception of spasticity frequency and severity following a SCI. With excellent internal consistency (ICC = 0.90), the current version was modified from the original to include both frequency and severity. A higher score means greater magnitude in spasms. | Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset | 
| Change in Patient Health Questionnaire - 9 (PHQ-9) | The PHQ-9 is a self-report measure to assess the presence of depressive symptoms. Each items is scored on the following scale: 0 - not at all - several days - more than half the days - nearly daily Total scores are calculated by adding all the score and provides a possible depression severity score: none (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27). A higher score means greater severity in depressive symptoms. | Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset | 
| Change in Life Satisfaction Questionnaire (LISAT) | The LISAT is a nine-item quality of life questionnaire suitable for SCI populations containing a single item assessing overall life satisfaction, along with eight additional domain-specific items. Items are answered on a 6-point likert scale that ranges from 1 (very dissatisfied), to 6 (very satisfied). The total Life Satisfaction score is computed as the mean of the item scores and the results are divided into dissatisfied (1-4) and satisfied (5-6). A higher score score means greater life satisfaction. | Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset | 
| Change in Physical Activity by GT9x Actigraph accelerometer | Active energy expenditure will be measured in counts per day using a GT9x Actigraph accelerometer. Patient will be instructed to wear the watch on an unaffected wrist for one week. Higher counts represent greater physical activity. | Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset | 
| Change in Neurophysiologic biomarkers by single pulse transcranial magnetic stimulation (TMS) | Motor evoked potential (MEP) amplitudes will be measured and indexed from lower extremity muscle by single pulse transcranial magnetic stimulation (TMS). | Change in baseline, within 5 days of discharge, within 5 days post-intervention (RGT Groups) or 1-month post-discharge (UC group), 1-month post-intervention or 2-months post-discharge (UC group) (5) 9-months post-SCI onset | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exoskeleton, Wearable assistive technology, Transcranial magnetic stimulation, Robotic gait training