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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05709587
• Other study ID #: KMUHIRB-F(I)-20190135
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: October 7, 2020

Study information

• Verified date: January 2020
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 7, 2020
• Est. primary completion date: October 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Virtual reality training
Virtual reality Training for 12 sessions, two to three times for one week, one training session last for 20 minutes

Locations

Country	Name	City	State
Taiwan	Kaohsiung Municipal Ta-Tung Hospital (operation under entrustment with Kaohsiung Medical University Hospital)	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

Fung J, Richards CL, Malouin F, McFadyen BJ, Lamontagne A. A treadmill and motion coupled virtual reality system for gait training post-stroke. Cyberpsychol Behav. 2006 Apr;9(2):157-62. doi: 10.1089/cpb.2006.9.157. — View Citation

Richards CL, Malouin F, Lamontagne A, McFadyen BJ, Dumas F, Comeau F, Robitaille NM, Fung J. Gait Training after Stroke on a Self-Paced Treadmill with and without Virtual Environment Scenarios: A Proof-of-Principle Study. Physiother Can. 2018 Summer;70(3):221-230. doi: 10.3138/ptc.2016-97. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Walking pace	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.
Primary	Walking endurance	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.
Primary	Balance test	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.
Primary	Activities-specific balance confidence scale	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.