AzTrials
AzTrials

StrokeNCT04750746

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

A study testing Experimental Group in people with Stroke and Cardiovascular Stroke, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 45 to 65 years
What is being tested?
Experimental Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 sitePakistan
Study dates
27 Mar 2020to 30 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Iram Shafee

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

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

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.

Being tested
Control group, Experimental Group
Medical subject headings
Stroke, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Control groupOther

    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 GroupOther

    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

Study groups in NCT04750746
Study groupRoleWhat they receive
Control GroupActive comparatorControl group will get conventional treatment.
Receives: Other: Control group
Experimental GroupExperimentalThis group will get base line treatment with exer gaming.
Receives: Other: Experimental Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 4 months

  2. 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.

    Measured: 4months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2021
  2. Study start27 Mar 2020
  3. Primary completion30 Dec 2020
  4. Study completion30 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04750746
Sponsor's protocol ID
REC/Lhr/20/2032 Yamna Mazhar
Status last verified
May 2021
First submitted
10 Feb 2021
Last updated
6 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31204204

  • 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.

    PubMed 30568325

  • 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.

    PubMed 28946996

  • 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.

    PubMed 29529895

  • 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.

    PubMed 24051993

  • 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.

    PubMed 31888293

  • 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.

    PubMed 29644897

Questions about this trial

What is this clinical trial studying?

A study testing Experimental Group in people with Stroke and Cardiovascular Stroke, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

upper extremity function (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04750746, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in