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

Spinal Cord Injuries Clinical Trial

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

Status Recruiting

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

• NCT number: NCT05218447
• Study type: Interventional
• Source: Baylor Research Institute
• Contact: Alexandria R Holden, MPH
• Phone: 469-531-1577
• Email: Alexandria.Holden@BSWHealth.org
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2022
• Completion date: September 14, 2026