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

NCT ID: NCT04781621

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-12
• Study Completion Date: 2024-03-08

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Robotic Gait Training

Patients in the Robotic Gait Training (RGT) group will receive 90 minutes per week of RGT once patients are deemed clinically appropriate as defined by being able to tolerate standing for 15 minutes without orthostatic intolerance. The duration of treatment will span the patient's length of stay in inpatient rehabilitation. The Ekso Bionics Ekso GT™ robotic exoskeleton will be used for RGT.

Group Type: EXPERIMENTAL

Robotic Gait Training

Intervention Type: DEVICE

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.

Usual Care Gait Training

Usual Care (UC) gait training including body weight-supported treadmill training (BWSTT) and conventional overground walking.

Group Type: ACTIVE_COMPARATOR

Usual Care Gait Training

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Other Intervention Names

EksoGT™ robotic exoskeleton; Standard of Care Gait Training; body-weight support treadmill training (BWSTT); Overground gait training with braces,

Eligibility Criteria

Inclusion Criteria

• 16 - 85 Years of Age
• All types of incomplete Spinal Cord Injury (SCI) (traumatic and non-traumatic)
• Acute/Subacute phase of recovery
• Medically stable as deemed by physician
• Undergoing medical care and inpatient rehabilitation at BSW
• 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

• Moderate to Severe Traumatic Brain Injury (TBI)
• Degenerative diagnoses
• Wound located in proximity to the exoskeleton frame
• Severe osteoporosis/-penia as shown with dual energy x-ray absorptiometry (DXA)
• Pre-morbid developmental disability, significant psychological diagnosis, or other cognitive impairment

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Disability, Independent Living, and Rehabilitation Research

FED

Sponsor Role: collaborator

Baylor Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Chad Swank

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chad D Swank, PhD

Role: PRINCIPAL_INVESTIGATOR

Baylor Research Institute

Locations

Baylor Scott & White Institute for Rehabilitation

Dallas, Texas, United States

Countries

United States

References

Swank C, Holden A, McDonald L, Driver S, Callender L, Bennett M, Sikka S. Foundational ingredients of robotic gait training for people with incomplete spinal cord injury during inpatient rehabilitation (FIRST): A randomized controlled trial protocol. PLoS One. 2022 May 10;17(5):e0267013. doi: 10.1371/journal.pone.0267013. eCollection 2022.

Reference Type: BACKGROUND

PMID: 35536844 (View on PubMed)

Other Identifiers

BSWRI IRB 020-483

Identifier Type: -

Identifier Source: org_study_id