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

Sponsor

Taichung Veterans General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05825144

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Sequelae	Device: Robotic exoskeleton-assisted gait rehabilitation Other: Conventional rehabilitation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Robotic group

This group receives conventional rehabilitation plus robotic exoskeleton-assisted gait rehabilitation.

Device: Robotic exoskeleton-assisted gait rehabilitation

Use a robotic exoskeleton for gait rehabilitation in addition to conventional rehabilitation

Active Comparator: Control group

This group receives conventional rehabilitation alone.

Other: Conventional rehabilitation

Regular post-stroke rehabilitation

Outcome Measures

Primary Outcome Measures

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) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taichung Veterans General Hospital	Taichung		Taiwan	407

Sponsors and Collaborators

Taichung Veterans General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Taichung Veterans General Hospital

ClinicalTrials.gov Identifier:

NCT05825144

Other Study ID Numbers:

CF21277A

First Posted:

Apr 24, 2023

Last Update Posted:

Apr 24, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Taichung Veterans General Hospital

robotic rehabilitation

stroke

quality of life

walking speed

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Apr 24, 2023