The Effect of Virtual Reality Therapy on Balance and Knee Control in Stroke Patients

March 30, 2024 updated by: Suleyman Korkusuz, Hacettepe University

The Effect of Virtual Reality Therapy Applied in Addition to Conventional Balance Training on Balance and Knee Control in Stroke Patients

The aim of study is to determine whether the Virtual Reality training applied in addition to the exercises given inside and outside the parallel bar is effective on balance, daily living activities and knee control in stroke patients.

The hypotheses of the study are:

Hypothesis 1:

H0: Virtual reality training has no effect on balance in stroke patients. H1: Virtual reality training has an effect on balance in stroke patients.

Hypothesis 2; H0: Virtual reality training has no effect on activities of daily living in stroke patients.

H1: Virtual reality training has an effect on daily living activities in stroke patients.

Hypothesis 3; H0: Virtual reality training has no effect on knee control in stroke patients. H1: Virtual reality training has an effect on knee control in stroke patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In recent years, virtual reality systems are widely preferred technology-assisted rehabilitation methods due to the many advantages they provide in stroke rehabilitation. Virtual reality increases the quality of movement and functional capacity both by providing a sensory environment and by motor learning.

Study Type

Interventional

Enrollment (Actual)

25

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

  • Turkey
      • Ankara, Turkey
        • Hacettepe University

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:

  • Being between the ages of 18-70
  • Having a stroke for the first time
  • Patients who can stand and walk independently

Exclusion Criteria:

  • Having neglect syndrome
  • Being bilaterally affected
  • Botulinum toxin application in the last three months
  • Having additional neurological diseases such as Parkinson's, multiple sclerosis

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Conventional Rehabilitation Group
In the conventional rehabilitation program, bed exercises, mat activities, balance exercises inside or outside the parallel bar and walking training will be given to the patients every weekday.
Other: Conventional Rehabilitation
In the conventional rehabilitation program, bed exercises, mat activities, balance exercises inside or outside the parallel bar and walking training will be given to the patients every weekday.
Experimental: Virtual Reality Therapy Group
The patients in this group will be able to play balance-based games with the Virtual Reality System for 20 minutes, 3 days a week, together with the conventional rehabilitation program.
Other: Conventional Rehabilitation
In the conventional rehabilitation program, bed exercises, mat activities, balance exercises inside or outside the parallel bar and walking training will be given to the patients every weekday.
Other: Virtual Reality Therapy
Patients in this group will play balance-based games with the Virtual Reality System.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Computerized Gait Assessment System (Zebris Rehawalk)
Time Frame: Baseline
Participants will walk at a comfortable walking speed on the treadmill. During the walk, the walk will be recorded with the video camera system integrated into the device. With the help of the system, the knee hyperextension angle during walking will be calculated with the markers placed on the recorded video.
Baseline
Computerized Gait Assessment System (Zebris Rehawalk)
Time Frame: 6.week (at the end of the training)
Participants will walk at a comfortable walking speed on the treadmill. During the walk, the walk will be recorded with the video camera system integrated into the device. With the help of the system, the knee hyperextension angle during walking will be calculated with the markers placed on the recorded video.
6.week (at the end of the training)
Barthel Index
Time Frame: Baseline
This scale consists of 10 items that evaluate nutrition, bathing, self-care, dressing, defecation control, urine control, going to the toilet, ability to move from bed to wheelchair, mobility status such as walking or being dependent on a wheelchair, and stair climbing functions.
Baseline
Barthel Index
Time Frame: 6.week (at the end of the training)
This scale consists of 10 items that evaluate nutrition, bathing, self-care, dressing, defecation control, urine control, going to the toilet, ability to move from bed to wheelchair, mobility status such as walking or being dependent on a wheelchair, and stair climbing functions.
6.week (at the end of the training)
Functional Reach Test
Time Frame: Baseline
It is based on the principle of lifting the arm 90° upwards and reaching forward as far as possible while keeping the feet on the ground. 15 cm. and the risk of falling below 15 cm increases significantly, between 15 and 25 cm. indicates a moderate risk of falling. Values less than 25.4 cm indicate an increased risk of falling.
Baseline
Functional Reach Test
Time Frame: 6.week (at the end of the training)
It is based on the principle of lifting the arm 90° upwards and reaching forward as far as possible while keeping the feet on the ground. 15 cm. and the risk of falling below 15 cm increases significantly, between 15 and 25 cm. indicates a moderate risk of falling. Values less than 25.4 cm indicate an increased risk of falling.
6.week (at the end of the training)
Timed Up and Go Test
Time Frame: Baseline
It is an objective, reliable and simple measure for assessing balance and functional mobility. It can also be used for assessment of fall risk.
Baseline
Timed Up and Go Test
Time Frame: 6.week (at the end of the training)
It is an objective, reliable and simple measure for assessing balance and functional mobility. It can also be used for assessment of fall risk.
6.week (at the end of the training)

Collaborators and Investigators

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

Sponsor

Hacettepe University

Investigators

  • Study Chair: Büşra Seçkinoğulları, MSc, Hacettepe University
  • Study Chair: Özlem Yürük, Prof.Dr., Baskent University
  • Principal Investigator: Süleyman Korkusuz, MSc, Atılım University
  • Study Chair: Gülşen Taşkın, Assist.Prof, Afyonkarahisar Sağlık Bilimleri University
  • Study Chair: Melike Sümeyye Cengiz, MSc, Bandırma Onyedi Eylül University

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)

May 16, 2023

Primary Completion (Actual)

March 1, 2024

Study Completion (Actual)

March 15, 2024

Study Registration Dates

First Submitted

May 24, 2023

First Submitted That Met QC Criteria

June 7, 2023

First Posted (Actual)

June 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

March 30, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-77

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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