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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: Virtual reality training

• Registration Number: NCT05709587
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief 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

Detailed 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

Study Timeline

• Status Verified: 2020-01
• Study Start: 2020-06-01
• Primary Completion: 2020-10-07
• Study Completion: 2020-10-07
• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-01-30
• Last Update Submitted: 2023-01-30
• Study First Posted: 2023-02-02
• Last Update Posted: 2023-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Virtual Reality training group	Virtual reality training	Virtual Reality training group: Three virtual environments employed in this study,time constraints,terrain changes, and moving obstacles were set to increase the difficulty of the walking task.The participants had to complete a task three times to proceed to the next level.

Primary Outcome Measures

Name	Time	Method
Balance test	Measure changes from baseline Berg Balance Scale score tested before the intervention to one week after completion of all interventions.	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.
Walking pace	Measure changes from baseline walking pace tested before the intervention to one week after completion of all interventions.	Use the 10 meters walking test to show the outcomes that presents in m/s.
Walking endurance	Measure changes from baseline walking distance tested before the intervention to one week after completion of all interventions.	Use the 6 minutes walking test to show the outcomes that calculate the distance in meters.
Activities-specific balance confidence scale	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.	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.

Trial Locations

Locations (1)

Kaohsiung Municipal Ta-Tung Hospital (operation under entrustment with Kaohsiung Medical University Hospital); 🇨🇳 Kaohsiung, Taiwan