Effects of PlayStation®VR on the HRQOL in Stroke Patients Undergoing Inpatient Rehabilitation

Stroke Clinical Trial

Official title:

Effects of PlayStation®VR on the Health-Related Quality of Life in Stroke Patients Undergoing Inpatient Rehabilitation: a Pilot Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04441177
• Other study ID #: 201801607A3
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 29, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: June 2020
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Compared to conventional rehabilitation therapy, the full-immersive commercial game (CG) system, in the form of available video game, could safely provide more positive effect on health-related quality of life (HRQOL) and motor function in post-stroke patients.

The study aims to perform the research from 2019/7/1 to 2021/6/30 and enrolls a total of 80 participants. Stroke participants are recruited from the rehabilitation ward of CGMH hospital.

The inclusion criteria are (a) first-time unilateral cerebral stroke, (b) stroke onset less or equal to 1 year, (c) admission to the rehabilitation ward, (d) ages 20-80 years, (e) spasticity of paretic arm ≤ grade 2 in the Modified Ashworth Scale, and (f) no active medical problems such as fever, pneumonia, or scabies. The exclusion criteria are (a) brainstem or cerebellar stroke, (b) epilepsy history, including photosensitive epilepsy, (c) previous or active heart diseases, such as myocardial infarction or angina, (d) visuospatial problems related to stroke, such as hemianopia or hemineglect, (e) paretic upper limb reaches Brunnstrom recovery stage VI, (f) severe aphasia, (g) severe cognitive impairment, and (h) poor cooperation with assessments.

All participants are randomly allocated to study group and control group. Participants in the control group receive conventional rehabilitation therapy over 50 minutes on weekdays. Participants in the study group receive conventional rehabilitation therapy over 50 minutes on weekdays and 7 sessions (flexible schedule in different day) of PlayStation®VR of 20 minutes each in the main 16-day study period. Pre-intervention, post-intervention, and 3-month follow-up HRQOL will be assessed by the Stroke Impact Scale 3.0. Motricity Index and Fugl-Meyer Assessment, Functional Independence Measure, and arm movement ratio will also be checked before intervention, after intervention, and at 3-month follow-up. The safety outcome, intervention-related adverse events or any serious adverse events, during study period will be recorded.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• first-time unilateral cerebral stroke

• stroke onset less or equal to 1 year

• admission to the rehabilitation ward

• ages 20-80 years

• spasticity of paretic arm = grade 2 in the Modified Ashworth Scale

• no active medical problems such as fever, pneumonia, or scabies

Exclusion Criteria:

• brainstem or cerebellar stroke

• epilepsy history, including photosensitive epilepsy

• previous or active heart diseases, such as myocardial infarction or angina

• visuospatial problems related to stroke, such as hemianopia or hemineglect

• paretic upper limb reaches Brunnstrom recovery stage VI

• severe aphasia

• severe cognitive impairment

• poor cooperation with assessments

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• PlayStation®VR training
Participants in the study group receive conventional rehabilitation therapy over 50 minutes on weekdays and 7 sessions (flexible schedule in different day) of PlayStation®VR of 20 minutes each in the main 16-day study period.

Locations

Country	Name	City	State
Taiwan	Chiayi Chang Gung Memorial Hospital	Pozi

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroke Impact Scale (SIS) 3.0 Questionnaire	Health-Related Quality of Life	Baseline (Pre-intervention at 2 days after enrollment)
Primary	Post-Intervention Change of Stroke Impact Scale (SIS) 3.0 Questionnaire	Post-intervention Health-Related Quality of Life	Change from baseline SIS scores at 18 days after enrollment
Primary	3-Month Follow-Up Change of Stroke Impact Scale (SIS) 3.0 Questionnaire	3-month follow-up Health-Related Quality of Life	Change from baseline SIS scores at 92 days after enrollment
Primary	Post-Intervention of Adverse Events or SAE	Proportion of intervention-related adverse events or SAE	16 days
Secondary	Motricity Index (MI) Upper Extremity Test	Motor impairment and function	Baseline (Pre-intervention) at 2 days after enrollment
Secondary	Post-Intervention Change of Motricity Index (MI) Upper Extremity Test	Post-intervention motor impairment and function	Change from baseline MI scores at 18 days after enrollment
Secondary	3-Month Follow-Up Change of Motricity Index (MI) Upper Extremity Test	3-month follow-up motor impairment and function	Change from baseline MI scores at 92 days after enrollment
Secondary	Fugl-Meyer Assessment for Upper Extremity (FMA-UE)	Motor impairment and function	Baseline (Pre-intervention) at 2 days after enrollment
Secondary	Post-Intervention Change of Fugl-Meyer Assessment for Upper Extremity (FMA-UE)	Post-intervention motor impairment and function	Change from baseline FMA-UE scores at 18 days after enrollment
Secondary	3-Month Follow-Up Change of Fugl-Meyer Assessment for Upper Extremity (FMA-UE)	3-month follow-up motor impairment and function	Change from baseline FMA-UE scores at 92 days after enrollment
Secondary	Self-Care in Functional Independence Measure (FIM) Instrument	The FIM is an 18-item instrument measuring a person's level of disability in terms of burden of care in six areas including self-care, continence, mobility, transfers, communication, and cognition. Each of the 18 items is graded on a scale of 1-7 based on level of independence in that item (1 = total assistance required, 7 = complete independence). Six items (eating, grooming, bathing, dressing upper body, dressing lower body, and toileting) of self care will be scored and summed in this study.	Baseline (Pre-intervention) at 2 days after enrollment
Secondary	Post-Intervention Change of Self-Care in Functional Independence Measure (FIM) Instrument	The FIM is an 18-item instrument measuring a person's level of disability in terms of burden of care in six areas including self-care, continence, mobility, transfers, communication, and cognition. Each of the 18 items is graded on a scale of 1-7 based on level of independence in that item (1 = total assistance required, 7 = complete independence). Six items (eating, grooming, bathing, dressing upper body, dressing lower body, and toileting) of self care will be scored and summed in this study.	Change from baseline self-care scores at 18 days after enrollment
Secondary	3-Month Follow-Up Change of Self-Care in Functional Independence Measure (FIM) Instrument	The FIM is an 18-item instrument measuring a person's level of disability in terms of burden of care in six areas including self-care, continence, mobility, transfers, communication, and cognition. Each of the 18 items is graded on a scale of 1-7 based on level of independence in that item (1 = total assistance required, 7 = complete independence). Six items (eating, grooming, bathing, dressing upper body, dressing lower body, and toileting) of self care will be scored and summed in this study.	Change from baseline self-care scores at 92 days after enrollment
Secondary	Arm Movement Ratio (AMR) Test	The AMR, the ratio of arm use duration between the more and less affected arm, is detected and calculated by an accelerometer. The participants are asked to wear one accelerometer (ActiGraph wGT3x-BT, ActiGraph, LLC., Pensacola, FL, USA) on each arm for 7 hours.	Baseline (Pre-intervention) at 1 day after enrollment
Secondary	Post-Intervention Change of Arm Movement Ratio (AMR) Test	The AMR, the ratio of arm use duration between the more and less affected arm, is detected and calculated by an accelerometer. The participants are asked to wear one accelerometer (ActiGraph wGT3x-BT, ActiGraph, LLC., Pensacola, FL, USA) on each arm for 7 hours.	Change from baseline AMR scores at 19 days after enrollment
Secondary	3-Month Follow-Up Change of Arm Movement Ratio (AMR) Test	The AMR, the ratio of arm use duration between the more and less affected arm, is detected and calculated by an accelerometer. The participants are asked to wear one accelerometer (ActiGraph wGT3x-BT, ActiGraph, LLC., Pensacola, FL, USA) on each arm for 7 hours.	Change from baseline AMR scores at 93 days after enrollment