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Effects of Virtual Reality Game on Upper Extremity Function for Stroke

Not Applicable
Completed
Conditions
Stroke
Interventions
Behavioral: virtual reality game traning
Behavioral: standard treatment
Registration Number
NCT04296032
Lead Sponsor
Taipei Medical University Shuang Ho Hospital
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
37
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
virtual reality groupvirtual reality game traningStandard treatment 30 minutes plus virtual reality game 30 minutes, twice a week for 9 weeks.
virtual reality groupstandard treatmentStandard treatment 30 minutes plus virtual reality game 30 minutes, twice a week for 9 weeks.
standard treatment groupstandard treatmentStandard treatment 60 minutes, twice a week for 9 weeks.
Primary Outcome Measures
NameTimeMethod
Fugl-Meyer Assessment-upper extremityChange 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 Outcome Measures
NameTimeMethod
DynanometerChange 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.

Stroke Impact ScaleChange 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.

Box and block testChange 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.

Active range of motion of shoulder and elbowChange from Baseline at 9 weeks

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

Modified Physical Activity Enjoyment ScaleEvery 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).

Adverse effect timesEvery training session during 18 sessions, total sessions continued to 9 weeks

To record the adverse effect times during the therapy.

Trial Locations

Locations (1)

Taipei Medical University Shuang Ho Hospital

🇨🇳

New Taipei City, Taiwan

Taipei Medical University Shuang Ho Hospital
🇨🇳New Taipei City, Taiwan
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