Dosing of Overground Robotic Gait Training with Functional Outcomes and Neuroplasticity After Spinal Cord Injury (DOOR SCI)

Baylor Scott and White Health (BSWH)

Status: Enrolling

Conditions: Spinal Cord Injuries

Treatments: Other: Usual Care (UC) Gait Training; Device: Robotic Gait Training

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05218447

BSWRI IRB 021-205

Details and patient eligibility

About

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

Full 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.

Enrollment: 144 estimated patients

Sex: All

Ages: 16 to 85 years old

Volunteers: No Healthy Volunteers

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
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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144 participants in 4 patient groups

Low Frequency

Experimental group

Description:

Subjects will receive 2 sessions of robotic gait training (RGT) per week for 12 weeks

Treatment:

Device: Robotic Gait Training

Moderate Frequency

Experimental group

Description:

Subjects will receive 3 sessions of robotic gait training (RGT) per week for 8 weeks

Treatment:

Device: Robotic Gait Training

High Frequency

Experimental group

Description:

Subjects will receive 4 sessions of robotic gait training (RGT) per week for 6 weeks

Treatment:

Device: Robotic Gait Training

Control Group

Active Comparator group

Description:

Subjects will receive usual care gait training without robotic gait training

Treatment:

Other: Usual Care (UC) Gait Training