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Completed

NCT Number: NCT05709587

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

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

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Key information

Conditions

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

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Kaohsiung City, 801, Taiwan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual Reality Training

Other

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

Primary outcomes

  1. Walking pace

    Time frame: 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.

  2. Walking endurance

    Time frame: 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.

  3. Balance test

    Time frame: 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.

  4. Activities-specific balance confidence scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 2, 2023
Registry last updated
Feb 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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