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Effects of Virtual Reality Game on Upper Extremity Function for Stroke

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04296032
Enrollment
37
Registered
2020-03-05
Start date
2020-05-02
Completion date
2021-07-25
Last updated
2021-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

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.

Interventions

BEHAVIORALvirtual reality game traning

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

BEHAVIORALstandard treatment

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

Sponsors

Taipei Medical University Shuang Ho Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Fugl-Meyer Assessment-upper extremityChange from Baseline at 9 weeksThe 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

MeasureTime frameDescription
DynanometerChange from Baseline at 9 weeksThe 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.
Active range of motion of shoulder and elbowChange from Baseline at 9 weeksThe active range of motion of shoulder and elbow were measured through pablo system.
Box and block testChange from Baseline at 9 weeksThe Box and block test (BBT) measures unilateral gross manual dexterity. The BBT score denotes the number of blocks transferred within 60 s.
Modified Physical Activity Enjoyment ScaleEvery training session during 18 sessions, total sessions continued to 9 weeksIt 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 weeksTo record the adverse effect times during the therapy.
Stroke Impact ScaleChange from Baseline at 9 weeksThe 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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026