Effects of Virtual Reality Game on Upper Extremity Function for Stroke

NCT04296032 | Completed

• 1 other identifier: TMU-JIRB N201912049
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment-upper extremity

  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.

  Change from Baseline at 9 weeks

Secondary Outcomes (6)

• Box and block test

  Change from Baseline at 9 weeks

• Dynanometer

  Change from Baseline at 9 weeks

• Active range of motion of shoulder and elbow

  Change from Baseline at 9 weeks

• Stroke Impact Scale

  Change from Baseline at 9 weeks

• Modified Physical Activity Enjoyment Scale

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

Study Arms (2)

virtual reality group

EXPERIMENTAL

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

Behavioral: virtual reality game traning; Behavioral: standard treatment

standard treatment group

ACTIVE COMPARATOR

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

Behavioral: standard treatment

Interventions

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.

virtual reality group

standard treatment BEHAVIORAL

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

standard treatment group; virtual reality group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (1)

Taipei Medical University Shuang Ho Hospital

New Taipei City, Taiwan

Location

Related Publications (16)

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

  PMID: 1088404 BACKGROUND

• 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.

  PMID: 11108762 BACKGROUND

• 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.

  PMID: 11251725 BACKGROUND

• 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.

  PMID: 25217124 BACKGROUND

• 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.

  PMID: 20805757 BACKGROUND

• 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.

  PMID: 10208552 BACKGROUND

• 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.

  PMID: 25012864 BACKGROUND

• 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.

  PMID: 29180589 BACKGROUND

• 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.

  PMID: 25906983 BACKGROUND

• 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.

  PMID: 25927099 BACKGROUND

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

  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.

  PMID: 23872681 BACKGROUND

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

  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.

  PMID: 28627862 BACKGROUND

• 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.

  PMID: 19261767 BACKGROUND

• 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.

  PMID: 36963203 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Hsinchieh Lee

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 5, 2020
• Study Start: May 2, 2020
• Primary Completion: June 25, 2021
• Study Completion: July 25, 2021
• Last Updated: September 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)