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

Primary Purpose

Stroke Sequelae

Status

Recruiting

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Robotic exoskeleton-assisted gait rehabilitation

Conventional rehabilitation

About this trial

This is an interventional treatment trial for Stroke Sequelae focused on measuring robotic rehabilitation, stroke, quality of life, walking speed

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Taichung Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robotic group

Control group

Arm Description

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

This group receives conventional rehabilitation alone.

Outcomes

Primary Outcome Measures

Change from baseline distance walked in 6 minute walk test after entire rehabilitation program (4 weeks)

Change from baseline time needed to complete Timed-Up-and-Go test after entire rehabilitation program (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

Change from baseline Isokinetic strength after entire rehabilitation program (4 weeks)

tested by isokinetic dynamometer

Secondary Outcome Measures

Full Information

NCT ID

NCT05825144

First Posted

March 19, 2023

Last Updated

April 11, 2023

Sponsor

Taichung Veterans General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05825144

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2022 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Taichung Veterans General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke Sequelae

Keywords

robotic rehabilitation, stroke, quality of life, walking speed

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Robotic group

Arm Type

Experimental

Arm Description

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

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

This group receives conventional rehabilitation alone.

Intervention Type

Device

Intervention Name(s)

Robotic exoskeleton-assisted gait rehabilitation

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Conventional rehabilitation

Intervention Description

Regular post-stroke rehabilitation

Primary Outcome Measure Information:

Title

Change from baseline distance walked in 6 minute walk test after entire rehabilitation program (4 weeks)

Time Frame

4 weeks

Title

Change from baseline time needed to complete Timed-Up-and-Go test after entire rehabilitation program (4 weeks)

Time Frame

4 weeks

Title

Change from baseline scores in 12-item short form survey after entire rehabilitation program (4 weeks)

Description

12-item short form survey (SF-12): scores range from 0 to 100, with higher scores indicating better physical and mental health functioning

Time Frame

4 weeks

Title

Change from baseline Isokinetic strength after entire rehabilitation program (4 weeks)

Description

tested by isokinetic dynamometer

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yuan-Yang Cheng, Dr.

Phone

+886-4-2359-2525

Ext

3500

yycheng@vghtc.gov.tw

Facility Information:

Facility Name

Taichung Veterans General Hospital

City

Taichung

ZIP/Postal Code

407

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yuan-Yang Cheng, Dr.

Phone

+886-4-2359-2525

Ext

3500

yycheng@vghtc.gov.tw

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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