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

Study Overview
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Brief Summary
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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.

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

Conditions
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Stroke Sequelae

Intervention / Treatment
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* Device: Robotic exoskeleton-assisted gait rehabilitation
* Other: Conventional rehabilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic group<br>This group receives conventional rehabilitation plus robotic exoskeleton-assisted gait rehabilitation. | Device: Robotic exoskeleton-assisted gait rehabilitation<br>* Use a robotic exoskeleton for gait rehabilitation in addition to conventional rehabilitation<br>|
| Active Comparator: Control group<br>This group receives conventional rehabilitation alone. | Other: Conventional rehabilitation<br>* Regular post-stroke rehabilitation<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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robotic rehabilitation, stroke, quality of life, walking speed