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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04750746
• Other study ID #: REC/Lhr/20/2032 Yamna Mazhar
• Status: Completed
• Phase: N/A
• Start date: March 27, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: May 2021
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Stroke
• Cerebrovascular Accident
• Myocardial Infarction
• Stroke

Intervention

Other:
• Control group
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
• Experimental Group
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

Locations

Country	Name	City	State
Pakistan	Iram Shafee	Lahore	Panjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (7)

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). pii: E5144. doi: 10.3390/ijerph16245144. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 months
Primary	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.	4months