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

Last updated: February 4, 2025
Sponsor: Baylor Research Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Spinal Cord Injuries

Treatment

Usual Care (UC) Gait Training

Robotic Gait Training

Clinical Study ID

NCT05218447
BSWRI IRB 021-205
  • Ages 16-85
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 forRehabilitation

  • 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

Exclusion Criteria:

  • Concurrent moderate to severe traumatic brain injury (TBI)

  • Degenerative diagnoses

  • Pre-morbid developmental disability, significant psychological diagnosis, or othercognitive impairment

  • Pregnancy

Study Design

Total Participants: 144
Treatment Group(s): 2
Primary Treatment: Usual Care (UC) Gait Training
Phase:
Study Start date:
May 20, 2022
Estimated Completion Date:
September 14, 2025

Study 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.

Connect with a study center

  • Baylor Scott & White Institute for Rehabilitation

    Dallas, Texas 75246
    United States

    Active - Recruiting

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