NCT04781621

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Baylor Research Institute · Academic / Other
• Sex: All
• Age: 16 Years – 85 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Spinal cord injury (SCI) due to trauma is estimated to affect 288,000 - 500,000 Americans, with about 17,700 new cases annually. Recovery of walking is a primary rehabilitation goal for patients and encouraged by therapists due to its relationship to quality of life, impact on health, psychological profile, and social participation after SCI. Recent technological advances with exoskeleton devices specifically for gait training may yield better walking recovery outcomes compared with usual care intervention approaches, such as body-weight support treadmill training (BWSTT) and overground gait training with braces, yet limited evidence exists for those with SCI. Aim 1: Use a Community-Based Participatory Research approach to develop an robotic gait training (RGT) program that meets the unique needs of people after incomplete SCI during inpatient rehabilitation. This will be achieved by establishing and engaging an Advisory Board of key stakeholders to review evidence-based literature, advise the research team on the unique aspects and goals of inpatient rehabilitation for people with SCI, review the RGT, and make recommendations for amendments to the RGT program based on our interim and final outcomes of the study over the funding period. Aim 2: Prospectively examine the efficacy of RGT compared to usual care gait training during inpatient rehabilitation in people with incomplete SCI. Aim 3: Compare the intensity of RGT and usual care gait training during inpatient rehabilitation.

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-04-12
• Primary completion: 2024-03-08
• Completion: 2024-03-08
• First posted: 2021-03-04
• Last updated: 2025-02-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study