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

April 11, 2023 updated by: Taichung Veterans General Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taichung, Taiwan, 407
        • Recruiting
        • Taichung Veterans General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

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)
Time Frame: 4 weeks
4 weeks
Change from baseline time needed to complete Timed-Up-and-Go test after entire rehabilitation program (4 weeks)
Time Frame: 4 weeks
4 weeks
Change from baseline scores in 12-item short form survey after entire rehabilitation program (4 weeks)
Time Frame: 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)
Time Frame: 4 weeks
tested by isokinetic dynamometer
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taichung Veterans General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

March 19, 2023

First Submitted That Met QC Criteria

April 11, 2023

First Posted (Actual)

April 24, 2023

Study Record Updates

Last Update Posted (Actual)

April 24, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CF21277A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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