Effects of Wearable Sensor Based Virtual Reality Game on Balance for Stroke

September 23, 2021 updated by: Taipei Medical University Shuang Ho Hospital

Effects of Wearable Sensor Based Virtual Reality Game on Balance for Patients With Stroke

Pablo is a new virtual reality (VR) game combined with wearable motion sensor system which can targeted intervention in an interactive environment, immediate and sensitive feedback about the user's performance, a motivating effect due to game-based feature. Unlike commercial camera systems such as Kinect or force platforms, the systems require a continuous sightline or restrict the base of support which may increase risk of falling. Few of studies had investigated the rehabilitation effects on balance with Pablo for patients with stroke. The purpose of this study is to investigate the effects of virtual reality training through Pablo system in patients with chronic stroke.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pablo is a new virtual reality (VR) game combined with wearable motion sensor system which can targeted intervention in an interactive environment, immediate and sensitive feedback about the user's performance, a motivating effect due to game-based feature. Unlike commercial camera systems such as Kinect or force platforms, the systems require a continuous sightline or restrict the base of support which may increase risk of falling. Few of studies had investigated the rehabilitation effects on balance with Pablo for patients with stroke.

PURPOSE: The purpose of this study is to investigate the effects of virtual reality training through Pablo system in patients with chronic stroke.

METHODS: A prospective, randomized, controlled, blinded assessor design was used. Patients with stroke were recruited and randomly assigned to a "virtual reality(VR) group" (n = 20) and "functional balance training (FBT) group" (n = 20). After 18 training sessions (60 minutes per session, 2 sessions per week), outcome measures which included the Berg Balance Scale, the Timed Up and Go Test (cognition), a gait analysis, the Activities-Specific Balance Confidence scale, Stroke Impact Scale (SIS), Level of pleasure, and frequency of adverse events. The data were analyzed using nonparametric tests, and significance was indicated at α < 0.05.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Taipei Medical University Shuang Ho Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients were included if they had first stroke with hemiplegia.
  • Could stand for 5 minutes without support.
  • Chronicity of >6 months.
  • Could understand instructions.
  • Brunnstrom stage of LE ≥Ⅲ.

Exclusion Criteria:

  • Patients who were aged <20 years and >75 years
  • Patients with visual or auditory impairment who were unable to see or hear the feedback from the device clearly
  • Montreal Cognitive Assessment <16
  • Modified Ashworth Scale score of >2
  • Patients with other medical symptoms that can affect movement.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: virtual reality group
18 sessions of standard treatment plus virtual reality treatment.
Behavioral: virtual reality treatment
18 virtual reality training through Pablo system (30 minutes a time, 2-3 times a week). Postural transition included sit-to-stand, sit down, reaching to different directions, stepping to different directions with weight transfer, and bending the trunk forward and side to side. The controller was attached to lower extremity or trunk to control the game, such as elevator, hot air balloon, shooting cans, etc.
Behavioral: standard treatment
18 standard rehabilitation sessions (60 minutes a time, 2-3 times a week). The rehabilitative protocol focus on strengthening, endurance training, ambulation, and ADL training that included: (1) Hip flexor and knee extensor strengthening with resistance progressing used by weight bag or Thera-band. (2) Cycle ergometer riding with increase speed and resistance. (3) Gait pattern and speed correcting through treadmill and parallel bar. (4) Hand functional training and strategy teaching for feeding, dressing, and toileting.
Active Comparator: standard treatment group
18 sessions of standard treatment plus balance training.
Behavioral: standard treatment
18 standard rehabilitation sessions (60 minutes a time, 2-3 times a week). The rehabilitative protocol focus on strengthening, endurance training, ambulation, and ADL training that included: (1) Hip flexor and knee extensor strengthening with resistance progressing used by weight bag or Thera-band. (2) Cycle ergometer riding with increase speed and resistance. (3) Gait pattern and speed correcting through treadmill and parallel bar. (4) Hand functional training and strategy teaching for feeding, dressing, and toileting.
Behavioral: balance training
18 balance training sessions (30 minutes a time, 2-3 times a week) (1) Facilitated the balance reaction through weight shifting exercise with standing on even surface to uneven surface, such as tilting board.(2) Postural transition included sit-to-stand, sit down, reaching to different directions, stepping to different directions with weight transfer, and bending the trunk forward and side to side. (3) Changed the standing requirement, such as single legged stance or lunge stance. (4) Increased perception complications through cognition or upper extremity task to improve dual task attention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Berg Balance Scale
Time Frame: Change from Baseline to 9 weeks follow up
It is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.
Change from Baseline to 9 weeks follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional reach test
Time Frame: Change from Baseline to 9 weeks follow up

Functional Reach Test (FRT) is a clinical outcome measure and assessment tool for ascertaining dynamic balance in one simple task. The patient is instructed to next to, but not touching, a wall and position the arm that is closer to the wall at 90 degrees of shoulder flexion with a closed fist. The assessor records the starting position at the 3rd metacarpal head on the yardstick.

Instruct the patient to "Reach as far as you can forward without taking a step." The location of the 3rd metacarpal is recorded. Scores are determined by assessing the difference between the start and end position is the reach distance, usually measured in inches. Three trials are done and the average of the last two is noted.
Change from Baseline to 9 weeks follow up
Time up and go-cognition
Time Frame: Change from Baseline to 9 weeks follow up
In the TUG-cog, patients were asked to complete the test while counting backward by 3 from a randomly selected number between 20 and 100.
Change from Baseline to 9 weeks follow up
Activities-specific Balance Confidence scale
Time Frame: Change from Baseline to 9 weeks follow up
Activities-specific balance confidence (ABC) scale is a subjective measure of confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness. Participants estimate on a scale of 0% to 100% how confident they are that they could perform activities such as picking a slipper up off of the floor or walking on a slippery surface without losing their balance. The item scores are then summed and divided by 16 to provide an overall mean balance confidence score.Higher scores indicate higher confidence.
Change from Baseline to 9 weeks follow up
Stroke Impact Scale-physical domain
Time Frame: Change from Baseline to 9 weeks follow up
The stroke impact scale (SIS) is a stroke-specific health-related quality of life (HRQoL) instrument, which was developed by Duncan et al. (1999) at the University of Kansas Medical Center, to measure the consequences of stroke in multiple domains, including physical (strength, hand function, activities of daily living (ADL), instrumental ADL, and mobility), emotion, memory/thinking, communication, and social participation. Where the score is the domain score for a particular domain, the mean is the mean of the nonmissing item scores within that domain, with each item scored in the range of 1 to 5. Using this algorithm, each domain score has a range of 0 to 100. Higher score indicate the higher health-related quality of life.
Change from Baseline to 9 weeks follow up
Modified Physical Activity Enjoyment Scale
Time Frame: Every training session during 18 sessions, total sessions continued to 9 weeks
It is used to measure the enjoyment of physical activity. The original 18-item PACES scale was used to assess enjoyment. Respondents were asked to rate "how you feel at the moment about the physical activity you have been doing"using a 7-point bipolar rating scale. Higher PACES scores reflect greater levels of enjoyment
Every training session during 18 sessions, total sessions continued to 9 weeks
Adverse event times
Time Frame: Every training session during 18 sessions, total sessions continued to 9 weeks
It is used to measure adverse event times, such as dizzy, pain, fall.
Every training session during 18 sessions, total sessions continued to 9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University Shuang Ho Hospital

Investigators

  • Principal Investigator: Hsinchieh Lee, master, Taipei Medical University, Taiwan, R.O.C.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2020

Primary Completion (Actual)

May 30, 2021

Study Completion (Actual)

July 25, 2021

Study Registration Dates

First Submitted

March 2, 2020

First Submitted That Met QC Criteria

March 4, 2020

First Posted (Actual)

March 5, 2020

Study Record Updates

Last Update Posted (Actual)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 23, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMU-JIRB N201912048

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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