Therapeutic Effects of Robotic Exoskeleton-Assisted Gait Re-habilitation and Predictive Factors of Significant Improvements in Stroke Patients

Not Applicable

Recruiting

• Conditions: Stroke Sequelae
• Interventions: Other: Conventional rehabilitation; Device: Robotic exoskeleton-assisted gait rehabilitation

• Registration Number: NCT05825144
• Lead Sponsor: Taichung Veterans General Hospital

Brief Summary

Investigators aimed to examine the effectiveness of robotic exoskeleton-assisted gait training in stroke rehabilitation, and to determine predicting factors of significant improvements in post-stroke patients. Investigators hypothesized that robotic assisted gait training brings better strength recovery and functional improvement.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2023-03
• Study First Submitted: 2023-03-19
• Study First Submitted QC: 2023-04-11
• Last Update Submitted: 2023-04-11
• Study First Posted: 2023-04-24
• Last Update Posted: 2023-04-24
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• patients aged from 30 to 80 years
• hemiparesis due to ischemic or hemorrhagic stroke in the last 6 months

Exclusion Criteria

• with a significant history of pain or injury of lower limbs that affected their walking ability,
• with cardiopulmonary diseases that prohibited exercise training
• with impaired cognitive function
• unable to complete the timed up-and-go test
• able to complete the timed up-and-go test in <20 seconds using walking device

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Conventional rehabilitation	This group receives conventional rehabilitation alone.
Robotic group	Robotic exoskeleton-assisted gait rehabilitation	This group receives conventional rehabilitation plus robotic exoskeleton-assisted gait rehabilitation.

Primary Outcome Measures

Name	Time	Method
Change from baseline time needed to complete Timed-Up-and-Go test after entire rehabilitation program (4 weeks)	4 weeks
Change from baseline distance walked in 6 minute walk test after entire rehabilitation program (4 weeks)	4 weeks
Change from baseline scores in 12-item short form survey after entire rehabilitation program (4 weeks)	4 weeks	12-item short form survey (SF-12): scores range from 0 to 100, with higher scores indicating better physical and mental health functioning
Change from baseline Isokinetic strength after entire rehabilitation program (4 weeks)	4 weeks	tested by isokinetic dynamometer

Trial Locations

Locations (1)

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan