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Completed

NCT Number: NCT04296032

Effects of Virtual Reality Game on Upper Extremity Function for Stroke

Virtual reality training had already been used in stroke rehabilitation, and previous studies supported that it could improve upper extremity ability and increase motivation and pleasure than conventional methods. Pablo is a new VR game combined with motion sensor system which can detect subject's activities. Unlike commercial camera systems such as Kinect or XBOX, the systems require a continuous sightline or enough active range of motion which may increase risk of compensatory movement. Few of studies had investigated the rehabilitation effects on upper extremity with Pablo for patients with stroke.The purpose of this study is to investigate the effects of virtual reality upper extremity training through Pablo system in patients with chronic stroke.

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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

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University Shuang Ho Hospital

New Taipei City, Taiwan

About this study

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

METHODS:Patients with mild to moderate motor deficits were recruited and randomly assigned to "VR plus standard rehabilitation group"(n=19), and "standard rehabilitation group" (n=19). After 12 training sessions (60 minutes a time, 2 times a week), the performance was assessed by a blinded assessor. The outcome measures included Fugl-Meyer Assessment-Upper Limb section(FMAUE), Box and block test(BBT), Dynanometer, active range of motion of shoulder and elbow,and Stroke Impact Scale.Modified Physical Activity Enjoyment Scale and adverse effect were recorded after each sessions.Collected data will be analyzed with sample T test by SPSS version 20.0, and alpha level was set at 0.05.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • First stroke with hemiplegia,
  • Chronicity of >6 months
  • Could understand instructions
  • Brunnstrom stage of UE ≥IV.

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 were excluded.

Treatment and study plan

virtual reality game traning

Behavioral

The controllers were attached to upper extremity to control the game. The game could train the shoulder, elbow, and wrist control.

Standard treatment

Behavioral

The program included bilateral hand, grasp/release, and pinch activities.

Primary outcomes

  1. Fugl-Meyer Assessment-upper extremity

    Time frame: Change from Baseline at 9 weeks

    The Fugl-Meyer Assessment-upper extremity (FMA-UE) measures motor impairment in the upper extremity. The assessment consists of 33 items, including movement, reflex, grasp, and coordination, and a total score of 66.

Secondary outcomes

  1. Box and block test

    Time frame: Change from Baseline at 9 weeks

    The Box and block test (BBT) measures unilateral gross manual dexterity. The BBT score denotes the number of blocks transferred within 60 s.

  2. Dynanometer

    Time frame: Change from Baseline at 9 weeks

    The grip dynamometer was used to measure the maximum isometric strength of the hand and forearm muscles. The mean score of 3 trials was calculated. For this measurement, the elbow was placed at 90° and the forearm was placed in mid-position.

  3. Active range of motion of shoulder and elbow

    Time frame: Change from Baseline at 9 weeks

    The active range of motion of shoulder and elbow were measured through pablo system.

  4. Stroke Impact Scale

    Time frame: Change from Baseline at 9 weeks

    The Stroke Impact Scale (SIS) is a quality of life measure designed specifically for patients with stroke. The instrument is a self-report questionnaire assessing eight domains: strength, hand function, activities of daily living (ADL)/instrumental ADL (IADL), mobility, communication, emotion, memory and thinking, and social participation.

  5. Modified Physical Activity Enjoyment Scale

    Time frame: Every training session during 18 sessions, total sessions continued to 9 weeks

    It is an scale that assesses enjoyment for physical activity by asking participants to rate "how you feel at the moment about the physical activity you have been doing" using a 7-point bipolar Likert scale, from 1 (I enjoy it) to 7 (I hate it).

  6. Adverse effect times

    Time frame: Every training session during 18 sessions, total sessions continued to 9 weeks

    To record the adverse effect times during the therapy.

Sponsors and collaborators

Lead sponsor

Taipei Medical University Shuang Ho Hospital

Other

Registry information

Official study title

Effects of Wearable Sensor Based Virtual Reality Game on Upper Extremity Function for Patients With Stroke

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 5, 2020
Registry last updated
Sep 24, 2021

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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