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

Chronic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05907473
• Other study ID #: 2023-77
• Status: Completed
• Phase: N/A
• Start date: May 16, 2023
• Est. completion date: March 15, 2024

Study information

• Verified date: March 2024
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 15, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Stroke
• Stroke

Intervention

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

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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)