Clinical trial NCT05218447: Dosing of Overground Robotic Gait Training with Functional Outcomes and Neuroplasticity After Spinal Cord Injury
Official title: Dosing of Overground Robotic Gait Training with Functional Outcomes and Neuroplasticity After Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Exoskeleton
Wearable assistive technology
Transcranial magnetic stimulation
Robotic gait training
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: Texas Woman&#39;s University
First posted: 2022-02-01
Enrollment: 144
Sex: ALL
Minimum age (years): 16
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief summary: 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: 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 compared to usual care only.

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.

Eligibility criteria: 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 \&amp; 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
* Pregnancy

Primary outcomes:
measure: Change in Walking Index for Spinal Cord Injury - II (WISCI-II) from baseline
timeFrame: 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 outcomes:
measure: Change in 10-Meter Walk Test (10MWT)
timeFrame: 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
measure: Change in Spinal Cord Independence Measure (SCIM)
timeFrame: 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
measure: Change in Numerical Pain Rating Scale (NPRS)
timeFrame: 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
measure: Change in Fatigue Severity Scale (FSS)
timeFrame: 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
measure: Change in Penn Spasm Frequency Scale (PSFS)
timeFrame: 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
measure: Change in Patient Health Questionnaire - 9 (PHQ-9)
timeFrame: 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
measure: Change in Life Satisfaction Questionnaire (LISAT)
timeFrame: 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
measure: Change in Physical Activity by GT9x Actigraph accelerometer
timeFrame: 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
measure: Change in Neurophysiologic biomarkers by single pulse transcranial magnetic stimulation (TMS)
timeFrame: 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
Other outcomes:
measure: Rate of adverse events
timeFrame: Through study completion, an average of 9 months
measure: Self-reported tolerance of treatment
timeFrame: Through study completion, an average of 9 months
measure: Rate of treatment completion
timeFrame: Through study completion, an average of 9 months
Locations:
city: Dallas
country: United States
facility: Baylor Scott & White Institute for Rehabilitation
state: Texas
Study officials:
affiliation: Baylor Research Institute
name: Chad Swank, PhD, PT, NCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Swank C, Trammell M, Bennett M, Ochoa C, Callender L, Sikka S, Driver S. The utilization of an overground robotic exoskeleton for gait training during inpatient rehabilitation-single-center retrospective findings. Int J Rehabil Res. 2020 Sep;43(3):206-213. doi: 10.1097/MRR.0000000000000409.
citation: Swank C, Sikka S, Driver S, Bennett M, Callender L. Feasibility of integrating robotic exoskeleton gait training in inpatient rehabilitation. Disabil Rehabil Assist Technol. 2020 May;15(4):409-417. doi: 10.1080/17483107.2019.1587014. Epub 2019 Mar 19.
citation: DiPasquale J, Trammell M, Clark K, Fowler H, Callender L, Bennett M, Swank C. Intensity of usual care physical therapy during inpatient rehabilitation for people with neurologic diagnoses. PM R. 2022 Jan;14(1):46-57. doi: 10.1002/pmrj.12577. Epub 2021 Apr 15.
citation: Swank C, Galvan C, DiPasquale J, Callender L, Sikka S, & Driver D. Lessons Learned with Robotic Exoskeleton Use During Rehabilitation - therapeutic and medical severity considerations. Technology & Disability. 2020; 32(2): 103-110.