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

Baylor Scott and White Health (BSWH)

Status: Completed

Conditions: Spinal Cord Injuries

Treatments: Device: Robotic Gait Training; Other: Usual Care Gait Training

Study type: Interventional

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

Identifiers

NCT04781621

BSWRI IRB 020-483

Details and patient eligibility

About

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).

Full 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.

Enrollment: 115 patients

Sex: All

Ages: 16 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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115 participants in 2 patient groups

Robotic Gait Training

Experimental group

Description:

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.

Treatment:

Device: Robotic Gait Training

Usual Care Gait Training

Active Comparator group

Description:

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

Treatment:

Other: Usual Care Gait Training