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Foundational Ingredients of Robotic Gait Training for People With Spinal Cord Injury During Inpatient Therapy

NCT04781621 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2026-05-05

No results posted yet for this study

Summary

The FIRST project compares the dose of robotic gait training (RGT) with usual care gait training for patients with spinal cord injury (SCI) undergoing rehabilitation at Baylor Scott \& White Institute for Rehabilitation (BSWIR).

Conditions

  • Spinal Cord Injuries

Interventions

DEVICE

Robotic Gait Training

Participants will wear an exoskeleton suit and receive robotic gait training with a physical therapist for 90 minutes each week. Robot gait training will include standing and walking activities while wearing the The Ekso Bionics Ekso GT™ robotic exoskeleton. Participants will be asked to complete questionnaires about walking and function. They will also be asked to wear a watch measuring their heart rate monitor.

OTHER

Usual Care Gait Training

Participants receive usual care gait training with a physical therapist for 90 minutes each week. Usual care gait training includes standard gait training involving standing and walking activities such as conventional overground walking, body weight-supported treadmill training (BWSTT), overground body weight-supported overground system, and various assistive devices (e.g., BWSTT, overground with braces, walker, etc.). Participants will be asked to complete questionnaires about walking and function. They will also be asked to wear a watch measuring their heart rate monitor and number of steps.

Sponsors & Collaborators

  • National Institute on Disability, Independent Living, and Rehabilitation Research

    collaborator FED

  • Baylor Research Institute

    lead OTHER

Principal Investigators

  • Seema Sikka, MD · Baylor Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-12
Primary Completion
2024-03-08
Completion
2024-03-08
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04781621 on ClinicalTrials.gov