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Exer-gaming on Upper Extremity Function and Activities of Daily Living in Sub-acute Stroke Patient.

Primary Purpose

Stroke, Cardiovascular Stroke, Cerebrovascular Accident

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Control group
Experimental Group
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1) First stroke 2) Patient of sub-acute stroke 3) Both gender 4) Between 45 to 65 years of age 6) Total score of 19 or greater on the Mini-Mental State Examination 7) No problems with auditory or visual functioning.

Exclusion Criteria:

  • 1) Patient with global aphasia, and blindness, 2) Taking any prescribed drugs that could potentially affect physical function and balance (such as corticosteroids, antipsychotics or antidepressants) 3) Uncontrolled blood pressure (HTN) 4) Cardiac conditions 5) History of seizure 6) Any intervention other than conventional therapy 7) Refusal to use a video game.

Sites / Locations

  • Iram Shafee

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Experimental Group

Arm Description

Control group will get conventional treatment.

This group will get base line treatment with exer gaming.

Outcomes

Primary Outcome Measures

upper extremity function
The Fugl-Meyer Upper Extremity (FMUE) Scale1 is a widely used and highly recommended stroke-specific, performance-based measure of impairment. The FMUE Scale comprises 33 items, each scored on a scale of 0 to 2, where 0 = cannot perform, 1 = performs partially and 2 = performs fully.
Activities of daily living
It was measured by stroke impact scale. The purpose of this questionnaire is to evaluate how stroke has impacted the health and life. On a scale of 0 to 100, with 100 representing full recovery and 0 representing no recovery.

Secondary Outcome Measures

Full Information

First Posted
February 10, 2021
Last Updated
May 1, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04750746
Brief Title
Exer-gaming on Upper Extremity Function and Activities of Daily Living in Sub-acute Stroke Patient.
Official Title
Effects of Exer-gaming on Upper Extremity Function and Activities of Daily Living in Sub-acute Stroke Patient.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
March 27, 2020 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Stroke is one of the leading cause of death, in adult stroke causes permanent disability. Stoke impact the life of a person significantly including the quality of life of an individual and especially performing the task of daily activities independently. About 50% survival of stroke have daily life activity limitation which is affecting their quality of life. Among stroke patients, 69% experience functional motor disturbance in their upper extremity. The aim of this study is to evaluate the effect of Exer-gaming by using the Xbox Kinect game system on upper extremity motor functions and the ability to perform ADLs in sub-acute stroke. Various treatment methods are used for the rehabilitation of stroke. This study will be a randomized controlled trial, used to compare the effectiveness of Exer gaming on upper extremity function and activities of daily living in sub-acute stroke patient. Subjects with Sub-acute stroke meeting the predetermined inclusion & exclusion criteria will be divided into two groups using simple random sampling technique. Pre assessment will be done using FMA & SIS measurements. Subjects in one group will be treated with Conventional therapy and exer gaming and the other will be treated with conventional therapy and activities training session. Each subject will be received a total 18 treatment sessions, with 3 treatment sessions per week for 6 weeks. Post treatment reading for FMA and SIS will be recorded after the end of treatment session. Recorded values will be analyzed for any change using SPSS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cardiovascular Stroke, Cerebrovascular Accident

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Control group will get conventional treatment.
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
This group will get base line treatment with exer gaming.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
Conventional Therapy Passive ROM and/or AROM exercises Muscle strengthening; Therapeutics stretching of the shoulder, the elbow, the wrist, and the fingers. Activities of daily living training, including eating, grooming, dressing, toileting, and transfer
Intervention Type
Other
Intervention Name(s)
Experimental Group
Intervention Description
Interventional therapy Xbox Kinect (Xbox 360, Microsoft,) For training, programs such as Boxing and Bowling in the Kinect sports pack and Rally Ball, 20,000 Leaks, and Space Pop in the Kinect adventure pack, all of which required the use of the upper extremities, will be selected
Primary Outcome Measure Information:
Title
upper extremity function
Description
The Fugl-Meyer Upper Extremity (FMUE) Scale1 is a widely used and highly recommended stroke-specific, performance-based measure of impairment. The FMUE Scale comprises 33 items, each scored on a scale of 0 to 2, where 0 = cannot perform, 1 = performs partially and 2 = performs fully.
Time Frame
4 months
Title
Activities of daily living
Description
It was measured by stroke impact scale. The purpose of this questionnaire is to evaluate how stroke has impacted the health and life. On a scale of 0 to 100, with 100 representing full recovery and 0 representing no recovery.
Time Frame
4months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1) First stroke 2) Patient of sub-acute stroke 3) Both gender 4) Between 45 to 65 years of age 6) Total score of 19 or greater on the Mini-Mental State Examination 7) No problems with auditory or visual functioning. Exclusion Criteria: 1) Patient with global aphasia, and blindness, 2) Taking any prescribed drugs that could potentially affect physical function and balance (such as corticosteroids, antipsychotics or antidepressants) 3) Uncontrolled blood pressure (HTN) 4) Cardiac conditions 5) History of seizure 6) Any intervention other than conventional therapy 7) Refusal to use a video game.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iram Shafee, M.Phil
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Iram Shafee
City
Lahore
State/Province
Panjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31204204
Citation
Henrique PPB, Colussi EL, De Marchi ACB. Effects of Exergame on Patients' Balance and Upper Limb Motor Function after Stroke: A Randomized Controlled Trial. J Stroke Cerebrovasc Dis. 2019 Aug;28(8):2351-2357. doi: 10.1016/j.jstrokecerebrovasdis.2019.05.031. Epub 2019 Jun 13.
Results Reference
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PubMed Identifier
30568325
Citation
Kim JH. Effects of a virtual reality video game exercise program on upper extremity function and daily living activities in stroke patients. J Phys Ther Sci. 2018 Dec;30(12):1408-1411. doi: 10.1589/jpts.30.1408. Epub 2018 Nov 21.
Results Reference
background
PubMed Identifier
28946996
Citation
Trombetta M, Bazzanello Henrique PP, Brum MR, Colussi EL, De Marchi ACB, Rieder R. Motion Rehab AVE 3D: A VR-based exergame for post-stroke rehabilitation. Comput Methods Programs Biomed. 2017 Nov;151:15-20. doi: 10.1016/j.cmpb.2017.08.008. Epub 2017 Aug 12.
Results Reference
background
PubMed Identifier
29529895
Citation
Nguyen AV, Ong YA, Luo CX, Thuraisingam T, Rubino M, Levin MF, Kaizer F, Archambault PS. Virtual reality exergaming as adjunctive therapy in a sub-acute stroke rehabilitation setting: facilitators and barriers. Disabil Rehabil Assist Technol. 2019 May;14(4):317-324. doi: 10.1080/17483107.2018.1447608. Epub 2018 Mar 12.
Results Reference
background
PubMed Identifier
24051993
Citation
Sin H, Lee G. Additional virtual reality training using Xbox Kinect in stroke survivors with hemiplegia. Am J Phys Med Rehabil. 2013 Oct;92(10):871-80. doi: 10.1097/PHM.0b013e3182a38e40.
Results Reference
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PubMed Identifier
31888293
Citation
Ahmad MA, Singh DKA, Mohd Nordin NA, Hooi Nee K, Ibrahim N. Virtual Reality Games as an Adjunct in Improving Upper Limb Function and General Health among Stroke Survivors. Int J Environ Res Public Health. 2019 Dec 16;16(24):5144. doi: 10.3390/ijerph16245144.
Results Reference
background
PubMed Identifier
29644897
Citation
Warland A, Paraskevopoulos I, Tsekleves E, Ryan J, Nowicky A, Griscti J, Levings H, Kilbride C. The feasibility, acceptability and preliminary efficacy of a low-cost, virtual-reality based, upper-limb stroke rehabilitation device: a mixed methods study. Disabil Rehabil. 2019 Sep;41(18):2119-2134. doi: 10.1080/09638288.2018.1459881. Epub 2018 Apr 12.
Results Reference
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Exer-gaming on Upper Extremity Function and Activities of Daily Living in Sub-acute Stroke Patient.

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