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

NCT05907473 | Completed

• 1 other identifier: 2023-77
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Stroke

Keywords

Virtual Reality; Stroke; Knee Hyperextension; Gait Analysis; Activities of Daily Living; Balance

Outcome Measures

Primary Outcomes (8)

• Computerized Gait Assessment System (Zebris Rehawalk)

  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)

  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

  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

  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

  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

  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

  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

  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)

Study Arms (2)

Conventional Rehabilitation Group

EXPERIMENTAL

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

Virtual Reality Therapy Group

EXPERIMENTAL

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: Virtual Reality Therapy; Other: Conventional Rehabilitation

Interventions

Virtual Reality Therapy OTHER

Patients in this group will play balance-based games with the Virtual Reality System.

Virtual Reality Therapy Group

Conventional Rehabilitation OTHER

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.

Conventional Rehabilitation Group; Virtual Reality Therapy Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

Related Publications (3)

• Palacios-Navarro G, Garcia-Magarino I, Ramos-Lorente P. A Kinect-Based System for Lower Limb Rehabilitation in Parkinson's Disease Patients: a Pilot Study. J Med Syst. 2015 Sep;39(9):103. doi: 10.1007/s10916-015-0289-0. Epub 2015 Aug 12.

  PMID: 26265237 BACKGROUND

• Park DS, Lee DG, Lee K, Lee G. Effects of Virtual Reality Training using Xbox Kinect on Motor Function in Stroke Survivors: A Preliminary Study. J Stroke Cerebrovasc Dis. 2017 Oct;26(10):2313-2319. doi: 10.1016/j.jstrokecerebrovasdis.2017.05.019. Epub 2017 Jun 9.

  PMID: 28606661 BACKGROUND

• Korkusuz S, Taskin G, Korkusuz BS, Ozen MS, Yuruk ZO. Examining the effects of non-immersive virtual reality game-based training on knee hyperextension control and balance in chronic stroke patients: a single-blind randomized controlled study. Neurol Sci. 2025 Mar;46(3):1267-1275. doi: 10.1007/s10072-024-07830-z. Epub 2024 Oct 28.

  PMID: 39466327 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Virtual Reality Exposure Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Özlem Yürük, Prof.Dr.

  Baskent University

  STUDY CHAIR

• Süleyman Korkusuz, MSc

  Atılım University

  PRINCIPAL INVESTIGATOR

• Gülşen Taşkın, Assist.Prof

  Afyonkarahisar Sağlık Bilimleri University

  STUDY CHAIR

• Melike Sümeyye Cengiz, MSc

  Bandırma Onyedi Eylül University

  STUDY CHAIR

• Büşra Seçkinoğulları, MSc

  Hacettepe University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 18, 2023
• Study Start: May 16, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 15, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)