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

Sponsor
Riphah International University (Other)
Overall Status
Completed
CT.gov ID
NCT04750746
Collaborator
(none)
32
Enrollment
1
Location
2
Arms
9.1
Actual Duration (Months)
3.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Control group
  • Other: Experimental Group
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Exer-gaming on Upper Extremity Function and Activities of Daily Living in Sub-acute Stroke Patient.
Actual Study Start Date :
Mar 27, 2020
Actual Primary Completion Date :
Dec 30, 2020
Actual Study Completion Date :
Dec 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Control Group

Control group will get conventional treatment.

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: Experimental Group

This group will get base line treatment with exer gaming.

Other: 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

Outcome Measures

Primary Outcome Measures

  1. upper extremity function [4 months]

    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.

  2. Activities of daily living [4months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
  1. Refusal to use a video game.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Iram Shafee Lahore Panjab Pakistan 54000

Sponsors and Collaborators

  • Riphah International University

Investigators

  • Principal Investigator: Iram Shafee, M.Phil, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT04750746
Other Study ID Numbers:
  • REC/Lhr/20/2032 Yamna Mazhar
First Posted:
Feb 11, 2021
Last Update Posted:
May 6, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Stroke
Myocardial Infarction

Study Results

No Results Posted as of May 6, 2021