Effects of Virtual Reality Game on Upper Extremity Function for Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04296032
• Other study ID #: TMU-JIRB N201912049
• Status: Completed
• Phase: N/A
• Start date: May 2, 2020
• Est. completion date: July 25, 2021

Study information

• Verified date: February 2021
• Source: Taipei Medical University Shuang Ho Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: July 25, 2021
• Est. primary completion date: June 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• 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.
• standard treatment
The program included bilateral hand, grasp/release, and pinch activities.

Locations

Country	Name	City	State
Taiwan	Taipei Medical University Shuang Ho Hospital	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Shuang Ho Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (15)

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. Review. — View Citation

Carod-Artal J, Egido JA, González 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. Review. — View Citation

Kopp B, Kunkel A, Mühlnickel 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. — View Citation

Laver KE, George S, Thomas S, Deutsch JE, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2015 Feb 12;(2):CD008349. doi: 10.1002/14651858.CD008349.pub3. Review. Update in: Cochrane Database Syst Rev. 2017 Nov 20;11:CD008349. — View Citation

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

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. — View Citation

Nordin N, Xie SQ, Wünsche 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. Review. — View Citation

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. — View Citation

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

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Box and block test	The Box and block test (BBT) measures unilateral gross manual dexterity. The BBT score denotes the number of blocks transferred within 60 s.	Change from Baseline at 9 weeks
Secondary	Dynanometer	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.	Change from Baseline at 9 weeks
Secondary	Active range of motion of shoulder and elbow	The active range of motion of shoulder and elbow were measured through pablo system.	Change from Baseline at 9 weeks
Secondary	Stroke Impact Scale	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.	Change from Baseline at 9 weeks
Secondary	Modified Physical Activity Enjoyment Scale	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).	Every training session during 18 sessions, total sessions continued to 9 weeks
Secondary	Adverse effect times	To record the adverse effect times during the therapy.	Every training session during 18 sessions, total sessions continued to 9 weeks