Clinical trial NCT04781621: Foundational Ingredients of Robotic Gait Training for People with Spinal Cord Injury During Inpatient Therapy
Official title: Foundational Ingredients of Robotic Gait Training for People with Spinal Cord Injury During Inpatient Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Gait Training
Exoskeleton
Physical Therapy
Physical Rehabilitation and Medicine
Inpatient Rehabilitation
Robotic Gait Training
Randomized Control Trial
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2021-03-04
Enrollment: 115
Sex: ALL
Minimum age (years): 16
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial. Patients are randomized into one of two groups: robotic exoskeleton gait training and usual care gait training.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Walking Index for Spinal Cord Injury - II (WISCI-II)
timeFrame: Within one week before discharge
Secondary outcomes:
measure: Gait speed via 10-Meter Walk Test (10MWT)
timeFrame: Within one week of admission before start of treatment; Within one week before discharge
measure: Spinal Cord Independence Measure (SCIM)
timeFrame: Within one week of admission before start of treatment; Within one week before discharge
measure: Numerical Pain Rating Scale (NPRS)
timeFrame: Within one week of admission before start of treatment; Within one week before discharge
measure: Fatigue Severity Scale (FSS)
timeFrame: Within one week of admission before start of treatment; Within one week before discharge
measure: Penn Spasm Frequency Scale (PSFS)
timeFrame: Within one week of admission before start of treatment; Within one week before discharge
measure: Patient Health Questionnaire - 9 (PHQ-9)
timeFrame: Within one week of admission before start of treatment; Within one week before discharge
measure: General Anxiety Disorder (GAD-7)
timeFrame: Within one week of admission before start of treatment; Within one week before discharge
measure: International Spinal Cord Injury Quality of Life Basic Data Set
timeFrame: Within one week of admission before start of treatment; Within one week before discharge
measure: Heart Rate (HR)
timeFrame: Immediately following every treatment until discharge, an average of 28 days
measure: Ratings of Perceived Exertion (RPE)
timeFrame: Immediately following every treatment session until discharge, an average of 28 days
measure: Number of Steps
timeFrame: Immediately following every treatment session until discharge, an average of 28 days
measure: Patient Perceptual Survey
timeFrame: Within one week before discharge
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor Scott & White Institute for Rehabilitation
state: Texas
Study officials:
affiliation: Baylor Research Institute
name: Chad D Swank, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.