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

Stroke Sequelae Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05825144
• Other study ID #: CF21277A
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: March 2023
• Source: Taichung Veterans General Hospital
• Contact: Yuan-Yang Cheng, Dr.
• Phone: +886-4-2359-2525
• Email: yycheng[@]vghtc.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Stroke Sequelae

Intervention

Device:
• Robotic exoskeleton-assisted gait rehabilitation
Use a robotic exoskeleton for gait rehabilitation in addition to conventional rehabilitation

Other:
• Conventional rehabilitation
Regular post-stroke rehabilitation

Locations

Country	Name	City	State
Taiwan	Taichung Veterans General Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline distance walked in 6 minute walk test after entire rehabilitation program (4 weeks)		4 weeks
Primary	Change from baseline time needed to complete Timed-Up-and-Go test after entire rehabilitation program (4 weeks)		4 weeks
Primary	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
Primary	Change from baseline Isokinetic strength after entire rehabilitation program (4 weeks)	tested by isokinetic dynamometer	4 weeks