NCT03980457

Effects of Exoskeleton-Assisted Gait Training on Functional Rehabilitation Outcomes in Patients With Stroke

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to determine the efficacy of electromechanical exoskeleton-assisted gait training on rehabilitation functional outcomes in patients with stroke undergoing therapy in an in-patient rehabilitation facility.

Detailed description

Abstract Objective: The goal of this study is to determine the efficacy of electromechanical exoskeleton-assisted gait training on rehabilitation functional outcomes in patients with stroke undergoing therapy in an in-patient rehabilitation facility. Background: Method: The investigators will study 50 patients with stroke consecutively admitted to a designated stroke rehabilitation unit in the Oklahoma City VA Medical Center. All patients will receive their daily 3-hours conventional therapy, plus an hour of either exoskeleton or over-ground gait training 3 times per week for 60 minutes. Patients were assigned to either the experimental (exoskeleton) or the control (over-ground) groups by computer-generated randomization. This is an open-label pragmatic trial, where neither the patients nor the clinicians could be masked to the intervention. Institution review board (IRB) approval will be obtained for the protocol. The demographic data to be collected includes: age, gender, race/ethnicity, stroke onset to admission, stroke types (ischemic/hemorrhagic), and stroke severity (on the National Institute of Health Stroke Severity \[NIHSS\] scale. Admission and discharge total Functional Independence Measure (FIM), spasticity and depression scores, ambulation velocity over 2-minutes (2-MWT) in feet/minute, and discharge disposition. The intervention is Indego® exoskeleton. The primary outcome measures were: changes in the FIM, depression and spasticity scores. The secondary outcome measure was discharge disposition. Continuous variables were analyzed using Students t-test, ordinal variables were analyzed using Mann-Whitney, and the nominal variables were analyzed using Chi-square analyses.

Conditions

• Stroke
• Weakness of Extremities as Sequela of Stroke

Interventions

Type	Name	Description
DEVICE	Indego Exoskeleton	Powered generated orthosis
OTHER	Standard Rehabilitation	Standard Rehabilitation

Timeline

• Start date: 2021-09-01
• Primary completion: 2026-09-01
• Completion: 2028-09-01
• First posted: 2019-06-10
• Last updated: 2026-04-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study