Impacts of Application of Virtual Reality on Gait and Balance for Stroke Patients

January 30, 2023 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital

Effects of Virtual Reality Training on the Balance, Gait, and Quality of Life Improvements of Patients With Stroke in the Subacute and Chronic Stages.

The goal of this clinical trial is to learn about effects of virtual reality combined with conventional therapy on the balance, gait, and quality of life in stroke patients in the subacute and chronic stages. The main questions it aims to answer are:

• Virtual reality combined conventional therapy interventions can improve the gait, balance and functional status of stroke patients or not?

Participants will asked to do about 3 tasks in virtual reality intervention

  • Walk in the flat ground
  • Cross the obstacle on the ground
  • Cross to moving obstacles

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators referred to the scenes designed by previous studies to develop the three virtual environments employed in this study and made slight modifications according to Taiwan's conditions. Google Earth Virtual Reality (Google Inc., Mountain View, California, U.S., 2017) was uesd for the first and second task and Street Champ Virtual Reality (Zynk Software Srl , Cluj, Romania, 2016) was used for the third task.

Time constraints, terrain changes, and moving obstacles were set to increase the difficulty of the walking task. The speed obtained by the 10-m walking pretest was used as the training benchmark. The participants had to complete a task three times to proceed to the next level.

For Patient Registries: on-site audit.The subjects were referred from the rehabilitation Clinic of Kaohsiung Municipal Ta-Tung Hospital

Study Type

Interventional

Enrollment (Actual)

17

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 Locations

  • Taiwan
      • Kaohsiung, Taiwan, 801
        • Kaohsiung Municipal Ta-Tung Hospital (operation under entrustment with Kaohsiung Medical University Hospital)

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

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1. Clinical diagnosis of Stroke. 2. Must be able to ambulation with or without devices. 3. Were able to communicate and follow instructions. 4. Were rehabilitated at Kaohsiung Municipal Ta-Tung Hospital.

Exclusion Criteria:

  • 1. Limb apraxia. 2. Any vision impairments. 3. Any hearing impairments. 4. Any vestibular impairments. 5. Any comorbidities that affected movements.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Virtual Reality training group
Virtual Reality training group: Three virtual environments employed in this study,time constraints,terrain changes, and moving obstacles were set to increase the difficulty of the walking task.The participants had to complete a task three times to proceed to the next level.
Other: Virtual reality training
Virtual reality Training for 12 sessions, two to three times for one week, one training session last for 20 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Walking pace
Time Frame: Measure changes from baseline walking pace tested before the intervention to one week after completion of all interventions.
Use the 10 meters walking test to show the outcomes that presents in m/s.
Measure changes from baseline walking pace tested before the intervention to one week after completion of all interventions.
Walking endurance
Time Frame: Measure changes from baseline walking distance tested before the intervention to one week after completion of all interventions.
Use the 6 minutes walking test to show the outcomes that calculate the distance in meters.
Measure changes from baseline walking distance tested before the intervention to one week after completion of all interventions.
Balance test
Time Frame: Measure changes from baseline Berg Balance Scale score tested before the intervention to one week after completion of all interventions.
Use the Berg Balance Scale to show the balance outcomes. It consists of 14 items scored 0 to 4 for a total of 56 points. A higher score means lower fall risk.
Measure changes from baseline Berg Balance Scale score tested before the intervention to one week after completion of all interventions.
Activities-specific balance confidence scale
Time Frame: Measure changes from baseline score of Chinese version of the activities-specific balance confidence scale tested before the intervention to one week after completion of all interventions.
Use the Chinese version of the activities-specific balance confidence scale to show the outcomes.It consists of 15 items every item score on 0 to 100. 0 means no confidence to perform the tasks, 100 means fully confidence to finish tasks.
Measure changes from baseline score of Chinese version of the activities-specific balance confidence scale tested before the intervention to one week after completion of all interventions.

Collaborators and Investigators

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

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

  • Principal Investigator: Yi-Chueh Tsai, BS, Kaohsiung Municipal Ta-Tung Hospital (Operation under entrustment with KMUH )

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 1, 2020

Primary Completion (ACTUAL)

October 7, 2020

Study Completion (ACTUAL)

October 7, 2020

Study Registration Dates

First Submitted

January 11, 2023

First Submitted That Met QC Criteria

January 30, 2023

First Posted (ACTUAL)

February 2, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 2, 2023

Last Update Submitted That Met QC Criteria

January 30, 2023

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMUHIRB-F(I)-20190135

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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