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

Primary Purpose

Chronic Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Virtual Reality Therapy
Conventional Rehabilitation
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Stroke focused on measuring Virtual Reality, Stroke, Knee Hyperextension, Gait Analysis, Activities of Daily Living, Balance

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hacettepe UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Conventional Rehabilitation Group

Virtual Reality Therapy Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 24, 2023
Last Updated
June 7, 2023
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05907473
Brief Title
The Effect of Virtual Reality Therapy on Balance and Knee Control in Stroke Patients
Official Title
The Effect of Virtual Reality Therapy Applied in Addition to Conventional Balance Training on Balance and Knee Control in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 16, 2023 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stroke
Keywords
Virtual Reality, Stroke, Knee Hyperextension, Gait Analysis, Activities of Daily Living, Balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional Rehabilitation Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Virtual Reality Therapy Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Virtual Reality Therapy
Intervention Description
Patients in this group will play balance-based games with the Virtual Reality System.
Intervention Type
Other
Intervention Name(s)
Conventional Rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Computerized Gait Assessment System (Zebris Rehawalk)
Description
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.
Time Frame
Baseline
Title
Computerized Gait Assessment System (Zebris Rehawalk)
Description
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.
Time Frame
6.week (at the end of the training)
Title
Barthel Index
Description
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.
Time Frame
Baseline
Title
Barthel Index
Description
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.
Time Frame
6.week (at the end of the training)
Title
Functional Reach Test
Description
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.
Time Frame
Baseline
Title
Functional Reach Test
Description
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.
Time Frame
6.week (at the end of the training)
Title
Timed Up and Go Test
Description
It is an objective, reliable and simple measure for assessing balance and functional mobility. It can also be used for assessment of fall risk.
Time Frame
Baseline
Title
Timed Up and Go Test
Description
It is an objective, reliable and simple measure for assessing balance and functional mobility. It can also be used for assessment of fall risk.
Time Frame
6.week (at the end of the training)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Süleyman Korkusuz, MSc
Phone
05388675480
Email
suleymankorkusuz@hacettepe.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Özlem Yürük, Prof.Dr.
Organizational Affiliation
Baskent University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Süleyman Korkusuz, MSc
Organizational Affiliation
Atılım University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ayla Fil Balkan, Assoc.Prof
Organizational Affiliation
Hacettepe University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gülşen Taşkın, Assist.Prof
Organizational Affiliation
Afyonkarahisar Sağlık Bilimleri University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Melike Sümeyye Cengiz, MSc
Organizational Affiliation
Bandırma Onyedi Eylül University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Büşra Seçkinoğulları, MSc
Organizational Affiliation
Hacettepe University
Official's Role
Study Chair
Facility Information:
Facility Name
Hacettepe University
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Süleyman Korkusuz, MSc
Phone
+905388675480
Email
suleymankorkusuz@hacettepe.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26265237
Citation
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.
Results Reference
background
PubMed Identifier
28606661
Citation
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.
Results Reference
background

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

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