Effects of Wearable Sensor Based Virtual Reality Game on Balance for Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
virtual reality treatment
standard treatment
balance training
Sponsored by

About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
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.
Sites / Locations
- Taipei Medical University Shuang Ho Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
virtual reality group
standard treatment group
Arm Description
18 sessions of standard treatment plus virtual reality treatment.
18 sessions of standard treatment plus balance training.
Outcomes
Primary Outcome Measures
Berg Balance Scale
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.
Secondary Outcome Measures
Functional reach test
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.
Time up and go-cognition
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.
Activities-specific Balance Confidence scale
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.
Stroke Impact Scale-physical domain
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.
Modified Physical Activity Enjoyment Scale
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
Adverse event times
It is used to measure adverse event times, such as dizzy, pain, fall.
Full Information
NCT ID
NCT04297774
First Posted
March 2, 2020
Last Updated
September 23, 2021
Sponsor
Taipei Medical University Shuang Ho Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04297774
Brief Title
Effects of Wearable Sensor Based Virtual Reality Game on Balance for Stroke
Official Title
Effects of Wearable Sensor Based Virtual Reality Game on Balance for Patients With Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 2, 2020 (Actual)
Primary Completion Date
May 30, 2021 (Actual)
Study Completion Date
July 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University Shuang Ho Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
virtual reality group
Arm Type
Experimental
Arm Description
18 sessions of standard treatment plus virtual reality treatment.
Arm Title
standard treatment group
Arm Type
Active Comparator
Arm Description
18 sessions of standard treatment plus balance training.
Intervention Type
Behavioral
Intervention Name(s)
virtual reality treatment
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
standard treatment
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
balance training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Berg Balance Scale
Description
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.
Time Frame
Change from Baseline to 9 weeks follow up
Secondary Outcome Measure Information:
Title
Functional reach test
Description
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.
Time Frame
Change from Baseline to 9 weeks follow up
Title
Time up and go-cognition
Description
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.
Time Frame
Change from Baseline to 9 weeks follow up
Title
Activities-specific Balance Confidence scale
Description
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.
Time Frame
Change from Baseline to 9 weeks follow up
Title
Stroke Impact Scale-physical domain
Description
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.
Time Frame
Change from Baseline to 9 weeks follow up
Title
Modified Physical Activity Enjoyment Scale
Description
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
Time Frame
Every training session during 18 sessions, total sessions continued to 9 weeks
Title
Adverse event times
Description
It is used to measure adverse event times, such as dizzy, pain, fall.
Time Frame
Every training session during 18 sessions, total sessions continued to 9 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsinchieh Lee, master
Organizational Affiliation
Taipei Medical University, Taiwan, R.O.C.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical University Shuang Ho Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Wearable Sensor Based Virtual Reality Game on Balance for Stroke
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