NCT06478680

Comparing Effects of Conventional Neurorehabilitation With Exoskeleton With High-intensity Gait Training

Comparing Effects of Conventional Neurorehabilitation With Exoskeleton With High-intensity Gait Training on Gait, Balance, and Depression Following Stroke and the Impact of Social Determinants of Health and Depression on Patients' Adherence to Physical Therapy

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Alvernia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research is to compare improvements between the rehab intervention with walking practice using the robotic exoskeleton versus walking practice that is vigorous enough to keep participants' heart rate over a certain target level during physical therapy sessions. Investigators want to compare improvements in your walking function and mental health that occur after 20 interventions. The study also aims to evaluate if participants' mental health, social support, and health literacy affect attendance at physical therapy sessions.

Conditions

• Stroke
• Gait, Hemiplegic

Interventions

Type	Name	Description
BEHAVIORAL	Exoskeleton mediated gait training	1 session of Forward Walking with EksoGT per week 1 session of conventional neurorehabilitation intervention per week * Transfer training * Gait training * Balance (sitting/standing; static/dynamic) * Strength * Neuromuscular re-education * Orthotics * Positioning * Caregiver education * Assistive device * Wheelchair assessment and mobility * Endurance training
BEHAVIORAL	High intensity gait training	2 sessions of High-Intensity Gait Training at a target heart rate of 60-80% of the maximum heart rate or target RPE of 15-18 * Forward stepping practice * Backwards stepping practices * Sidestepping * Stairs * Balance and compliant surface training while walking * Propulsion * Lateral balance training * Stability training * Stance control training * Limb advancement

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-05-30
• Completion: 2025-05-30
• First posted: 2024-06-27
• Last updated: 2025-07-11

Locations

1 site across 1 country: United States