Clinical trial NCT05709587: Impacts of Application of Virtual Reality on Gait and Balance for Stroke Patients
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
balance
virtual reality
walking pace
gait
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 17
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The subjects that received virtual reality functional gait training for 12 sessions. During the virtual reality intervention, they also received routine conventional rehabilitation therapy for twice a week, and training lasted for one hour. The 6-minute walking test (6MWT), 10-meter walk test (10MWT), Berg balance scale (BBS) and Chinese version of the Activities specific Balance Confidence scale were assessed pre- and post-intervention.
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Walking pace
timeFrame: Measure changes from baseline walking pace tested before the intervention to one week after completion of all interventions.
measure: Walking endurance
timeFrame: Measure changes from baseline walking distance tested before the intervention to one week after completion of all interventions.
measure: Balance test
timeFrame: Measure changes from baseline Berg Balance Scale score tested before the intervention to one week after completion of all interventions.
measure: Activities-specific balance confidence scale
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Municipal Ta-Tung Hospital (operation under entrustment with Kaohsiung Medical University Hospital)
Study officials:
affiliation: Kaohsiung Municipal Ta-Tung Hospital (Operation under entrustment with KMUH )
name: Yi-Chueh Tsai, BS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.