Effects of Virtual Reality Game on Upper Extremity Function for Stroke

NCT ID: NCT04296032

Last Updated: 2021-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-02

Study Completion Date

2021-07-25

Brief Summary

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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

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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virtual reality group

Standard treatment 30 minutes plus virtual reality game 30 minutes, twice a week for 9 weeks.

Group Type EXPERIMENTAL

virtual reality game traning

Intervention Type BEHAVIORAL

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

standard treatment

Intervention Type BEHAVIORAL

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

standard treatment group

Standard treatment 60 minutes, twice a week for 9 weeks.

Group Type ACTIVE_COMPARATOR

standard treatment

Intervention Type BEHAVIORAL

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

Interventions

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virtual reality game traning

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

Intervention Type BEHAVIORAL

standard treatment

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Medical University Shuang Ho Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hsinchieh Lee

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University, Taiwan, R.O.C.

Locations

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Taipei Medical University Shuang Ho Hospital

New Taipei City, , Taiwan

Site Status

Countries

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Taiwan

References

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Hatano S. Experience from a multicentre stroke register: a preliminary report. Bull World Health Organ. 1976;54(5):541-53.

Reference Type BACKGROUND
PMID: 1088404 (View on PubMed)

Carod-Artal J, Egido JA, Gonzalez JL, Varela de Seijas E. Quality of life among stroke survivors evaluated 1 year after stroke: experience of a stroke unit. Stroke. 2000 Dec;31(12):2995-3000. doi: 10.1161/01.str.31.12.2995.

Reference Type BACKGROUND
PMID: 11108762 (View on PubMed)

Chiu L, Shyu WC, Liu YH. Comparisons of the cost-effectiveness among hospital chronic care, nursing home placement, home nursing care and family care for severe stroke patients. J Adv Nurs. 2001 Feb;33(3):380-6. doi: 10.1046/j.1365-2648.2001.01703.x.

Reference Type BACKGROUND
PMID: 11251725 (View on PubMed)

Nordin N, Xie SQ, Wunsche B. Assessment of movement quality in robot- assisted upper limb rehabilitation after stroke: a review. J Neuroeng Rehabil. 2014 Sep 12;11:137. doi: 10.1186/1743-0003-11-137.

Reference Type BACKGROUND
PMID: 25217124 (View on PubMed)

Jang SH. The recovery of walking in stroke patients: a review. Int J Rehabil Res. 2010 Dec;33(4):285-9. doi: 10.1097/MRR.0b013e32833f0500.

Reference Type BACKGROUND
PMID: 20805757 (View on PubMed)

Kopp B, Kunkel A, Muhlnickel W, Villringer K, Taub E, Flor H. Plasticity in the motor system related to therapy-induced improvement of movement after stroke. Neuroreport. 1999 Mar 17;10(4):807-10. doi: 10.1097/00001756-199903170-00026.

Reference Type BACKGROUND
PMID: 10208552 (View on PubMed)

Basteris A, Nijenhuis SM, Stienen AH, Buurke JH, Prange GB, Amirabdollahian F. Training modalities in robot-mediated upper limb rehabilitation in stroke: a framework for classification based on a systematic review. J Neuroeng Rehabil. 2014 Jul 10;11:111. doi: 10.1186/1743-0003-11-111.

Reference Type BACKGROUND
PMID: 25012864 (View on PubMed)

Correction to: Guidelines for Adult Stroke Rehabilitation and Recovery: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2017 Dec;48(12):e369. doi: 10.1161/STR.0000000000000156. No abstract available.

Reference Type BACKGROUND
PMID: 29180589 (View on PubMed)

Susanto EA, Tong RK, Ockenfeld C, Ho NS. Efficacy of robot-assisted fingers training in chronic stroke survivors: a pilot randomized-controlled trial. J Neuroeng Rehabil. 2015 Apr 25;12:42. doi: 10.1186/s12984-015-0033-5.

Reference Type BACKGROUND
PMID: 25906983 (View on PubMed)

Laver KE, George S, Thomas S, Deutsch JE, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2015 Feb 12;2015(2):CD008349. doi: 10.1002/14651858.CD008349.pub3.

Reference Type BACKGROUND
PMID: 25927099 (View on PubMed)

Smith, C., et al., Can non-immersive virtual reality improve physical outcomes of rehabilitation? Physical Therapy Reviews, 2012. 17(1): p. 1-15.

Reference Type BACKGROUND

Peters DM, McPherson AK, Fletcher B, McClenaghan BA, Fritz SL. Counting repetitions: an observational study of video game play in people with chronic poststroke hemiparesis. J Neurol Phys Ther. 2013 Sep;37(3):105-11. doi: 10.1097/NPT.0b013e31829ee9bc.

Reference Type BACKGROUND
PMID: 23872681 (View on PubMed)

Laver, K.E., et al., Virtual reality for stroke rehabilitation. Stroke, 2018. 49(4): p. e160-e161.

Reference Type BACKGROUND

Lin LF, Lin YJ, Lin ZH, Chuang LY, Hsu WC, Lin YH. Feasibility and efficacy of wearable devices for upper limb rehabilitation in patients with chronic stroke: a randomized controlled pilot study. Eur J Phys Rehabil Med. 2018 Jun;54(3):388-396. doi: 10.23736/S1973-9087.17.04691-3. Epub 2017 Jun 19.

Reference Type BACKGROUND
PMID: 28627862 (View on PubMed)

Chen HM, Chen CC, Hsueh IP, Huang SL, Hsieh CL. Test-retest reproducibility and smallest real difference of 5 hand function tests in patients with stroke. Neurorehabil Neural Repair. 2009 Jun;23(5):435-40. doi: 10.1177/1545968308331146. Epub 2009 Mar 4.

Reference Type BACKGROUND
PMID: 19261767 (View on PubMed)

Kuo FL, Lee HC, Kuo TY, Wu YS, Lee YS, Lin JC, Huang SW. Effects of a wearable sensor-based virtual reality game on upper-extremity function in patients with stroke. Clin Biomech (Bristol). 2023 Apr;104:105944. doi: 10.1016/j.clinbiomech.2023.105944. Epub 2023 Mar 11.

Reference Type DERIVED
PMID: 36963203 (View on PubMed)

Other Identifiers

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TMU-JIRB N201912049

Identifier Type: -

Identifier Source: org_study_id

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