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

Part of paid clinical trials in Dallas, Texas.

Sponsor
Baylor Research Institute
Study ID
NCT05218447
Status
Recruiting
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Conditions

  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
16 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Robotic Gait Training — DEVICE
    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.
  • Usual Care (UC) Gait Training — OTHER
    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.

Study Details

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

Key Dates

Start date
May 20, 2022
Status verified
Sep 2024
Primary completion
Jun 14, 2025
Completion
Sep 14, 2025

Study Design

Enrollment
144 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Low Frequency
    Subjects will receive 2 sessions of robotic gait training (RGT) per week for 12 weeks
  • Experimental: Moderate Frequency
    Subjects will receive 3 sessions of robotic gait training (RGT) per week for 8 weeks
  • Experimental: High Frequency
    Subjects will receive 4 sessions of robotic gait training (RGT) per week for 6 weeks
  • Active Comparator: Control Group
    Subjects will receive usual care gait training without robotic gait training

Primary Outcome Measure

Change in Walking Index for Spinal Cord Injury - II (WISCI-II) from baseline [ Time Frame: 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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor Scott & White Institute for RehabilitationDallasTexas75246
Baylor Scott & White Institute for Rehabilitation

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Baylor Scott & White Institute for Rehabilitation· Dallas, TX

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