Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Spinal Cord Injuries
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized Control Trial. Patients are randomized into one of two groups: robotic exoskeleton gait training and usual care gait training.Masking: Single (Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 70 years
Gender
Both males and females

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 ...

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.

Tracking Information

NCT #
NCT04781621
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research
Investigators
Principal Investigator: Chad D Swank, PhD BSWRI Study Director: Katherine Froehlich-Grobe, PhD BSWRI