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

Spinal Cord Injuries Clinical Trial

— DOOR SCI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05218447
• Other study ID #: BSWRI IRB 021-205
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2022
• Est. completion date: September 14, 2026

Study information

• Verified date: December 2021
• Source: Baylor Research Institute
• Contact: Alexandria R Holden, MPH
• Phone: 469-531-1577
• Email: Alexandria.Holden[@]BSWHealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: September 14, 2026
• Est. primary completion date: June 14, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Device:
• Robotic Gait Training
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.

Other:
• Usual Care (UC) Gait Training
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.

Locations

Country	Name	City	State
United States	Baylor Scott & White Institute for Rehabilitation	Dallas	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Baylor Research Institute	Texas Woman's University, United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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.

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of adverse events	Number of adverse events occurring at baseline through study completion.	Through study completion, an average of 9 months
Other	Self-reported tolerance of treatment	Subjects provide feedback on their tolerance of treatment sessions via an 18-item questionnaire. The questionnaire measures tolerability on a scale 0 (Not tolerable at all to 10 (Maximally tolerable). A higher score means greater tolerability in robotic gait training.	Through study completion, an average of 9 months
Other	Rate of treatment completion	The average number of session attended divided by the number of scheduled sessions.	Through study completion, an average of 9 months
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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