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

NCT05709587 | Completed

• 1 other identifier: KMUHIRB-F(I)-20190135
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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

Conditions

Stroke

Keywords

stroke; balance; virtual reality; walking pace; gait

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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.

• 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.

Study Arms (1)

Virtual Reality training group

EXPERIMENTAL

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.

Other: Virtual reality training

Interventions

Virtual reality training OTHER

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

Virtual Reality training group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \. Limb apraxia. 2. Any vision impairments. 3. Any hearing impairments. 4. Any vestibular impairments. 5. Any comorbidities that affected movements.

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Municipal Ta-Tung Hospital (operation under entrustment with Kaohsiung Medical University Hospital)

Kaohsiung City, 801, Taiwan

Location

Related 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.

  PMID: 16640470 BACKGROUND

• 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.

  PMID: 30275647 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yi-Chueh Tsai, BS

  Kaohsiung Municipal Ta-Tung Hospital (Operation under entrustment with KMUH )

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: February 2, 2023
• Study Start: June 1, 2020
• Primary Completion: October 7, 2020
• Study Completion: October 7, 2020
• Last Updated: February 2, 2023

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)