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Comparison of Exergaming Training With Visual Feedback Training on Upper Limb Functions in Post Stroke Patients

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Exergaming Training
Visual Feedback Training
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke focused on measuring upper limb functions

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Both genders Subacute and chronic patients of stroke (> 4 weeks). Age: 40-70 years Able to follow verbal instructions related to the visual feedback training. MMSE score >21 Modified Ashworth scale (MAS) level 1-3 Brunnstrom stages 1-4 Fugyl Meyer score limit for upper limb Exclusion Criteria: Patients with Cognitive and Visual impairments Psychological disorder History of other neurological disorders Pusher's syndrome Hemineglect Abnormal synergic pattern Rheumatoid arthritis or other hand impairments

Sites / Locations

  • HafsaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exergaming Training Group

Visual Feedback Training

Arm Description

VR game-assisted intervention will perform for 30-45 min, 5 sessions per week for a duration of 8 weeks.

During the visual feedback practices, patients will be seated or in a standing phase close to a table on which a mirror would be placed vertically. The practice would be consisted of nonparetic-side shoulder, elbow, wrist and finger flexion, extension, abduction, adduction movements, task oriented activities like, unscrewing lid of jar ,card stacking, moving coins or marbles from one box to another, Folding towels and stacking them, picking glass, while patient will look into the mirror, -watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. After watching the practices on the uninvolved side, patient will be asked to try to do the same movements with the paretic limb while they will be moving the nonparetic limb. Each activity will be performed for 4 min, with a 1 min preparation time between tasks.

Outcomes

Primary Outcome Measures

Fugyl Meyer Assessment scale
It is now widely used for clinical assessment of motor function. This is an impairment-based test with items organized by sequential recovery stages. Change from baseline and 2 months
Box and block test
The Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick, simple and inexpensive test. It can be used with a wide range of populations, including clients with stroke. Change from baseline and 2 months
wolf motor function test
The Wolf Motor Function Test (WMFT) quantifies upper extremity movement ability through timed single- or multiple-joint motions and functional tasks. Change from baseline and 2 months

Secondary Outcome Measures

Full Information

First Posted
January 4, 2023
Last Updated
February 23, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05673421
Brief Title
Comparison of Exergaming Training With Visual Feedback Training on Upper Limb Functions in Post Stroke Patients
Official Title
Comparison of Exergaming Training With Visual Feedback Training on Upper Limb Functions in Post Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2023 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

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
Yes

5. Study Description

Brief Summary
Stroke is classically characterized as a neurological deficit attributed to an acute focal injury of the central nervous system (CNS) by a vascular cause, including transient ischemic attack, cerebral infarction, intracerebral hemorrhage, and subarachnoid hemorrhage. It is a major cause of disability and death worldwide. The main purpose of this study to determine the effect of exergaming training compared to visual feedback training on improvement in upper limb function.
Detailed Description
Stroke patients have various problems such weight. The loss of motion element involved on fine functions, and the above-mentioned problems can lead to decreased muscle cooperativity of the lower limbs while walking and may also result in an asymmetric gait due to imbalance in the ability to perform exercises. Recent studies on the treatment of stroke patients reported that approaches such as more intensive and repetitive training as compared to conventional general and passive intervention, training related to reality, intervention involving motivation and active participation and forced induction exercise, visual exercise feedback, purpose-oriented training, and task-oriented training are more effective in promoting function after stroke onset. Virtual reality (VR) is frequently used in different disease groups at the clinic for rehabilitation purposes. Xbox Kinect, Nintendo Wii, Sony PlayStation, and Cyber Glove are among the most commonly used VR applications in rehabilitation. Several studies reported that VR applications improved both upper and lower extremity functions and promoted independence in performing activities of daily living. Games based on virtual reality for stroke rehabilitation are mainly focused on motor rehabilitation. Nevertheless, interest in the integration of cognitive and motor rehabilitation has grown. Research shows that the use of virtual reality-based games improves the range of motion as well as the memory and attention of stroke patients. Benefits of virtual reality games include diverse and intensive exercises, designing exercises tailored to patients' abilities, monitoring patients' progress, and boosting patients' motivation. Game-based virtual reality is an emerging technology in healthcare allowing users to interact with a dynamic 3D environment. Studies show that this technology is an effective, feasible and safe solution which makes rehabilitation more convenient. In addition, computer games increase motivation, satisfaction and involvement of patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
upper limb functions

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Exergaming training
Masking
Participant
Masking Description
Visual Feedback Training Group
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exergaming Training Group
Arm Type
Experimental
Arm Description
VR game-assisted intervention will perform for 30-45 min, 5 sessions per week for a duration of 8 weeks.
Arm Title
Visual Feedback Training
Arm Type
Active Comparator
Arm Description
During the visual feedback practices, patients will be seated or in a standing phase close to a table on which a mirror would be placed vertically. The practice would be consisted of nonparetic-side shoulder, elbow, wrist and finger flexion, extension, abduction, adduction movements, task oriented activities like, unscrewing lid of jar ,card stacking, moving coins or marbles from one box to another, Folding towels and stacking them, picking glass, while patient will look into the mirror, -watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. After watching the practices on the uninvolved side, patient will be asked to try to do the same movements with the paretic limb while they will be moving the nonparetic limb. Each activity will be performed for 4 min, with a 1 min preparation time between tasks.
Intervention Type
Other
Intervention Name(s)
Exergaming Training
Intervention Description
VR game-assisted intervention will perform for 30-45 min, 5 sessions per week for a duration of 8 weeks
Intervention Type
Other
Intervention Name(s)
Visual Feedback Training
Intervention Description
During the visual feedback practices, patients will be seated or in a standing phase close to a table on which a mirror would be placed vertically. The practice would be consisted of nonparetic-side shoulder, elbow, wrist and finger flexion, extension, abduction, adduction movements, task oriented activities like, unscrewing lid of jar ,card stacking, moving coins or marbles from one box to another, Folding towels and stacking them, picking glass, while patient will look into the mirror, -watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. After watching the practices on the uninvolved side, patient will be asked to try to do the same movements with the paretic limb while they will be moving the nonparetic limb.Each activity will be performed for 4 min, with a 1 min preparation time between tasks.
Primary Outcome Measure Information:
Title
Fugyl Meyer Assessment scale
Description
It is now widely used for clinical assessment of motor function. This is an impairment-based test with items organized by sequential recovery stages. Change from baseline and 2 months
Time Frame
2 months
Title
Box and block test
Description
The Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick, simple and inexpensive test. It can be used with a wide range of populations, including clients with stroke. Change from baseline and 2 months
Time Frame
2 months
Title
wolf motor function test
Description
The Wolf Motor Function Test (WMFT) quantifies upper extremity movement ability through timed single- or multiple-joint motions and functional tasks. Change from baseline and 2 months
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Both genders Subacute and chronic patients of stroke (> 4 weeks). Age: 40-70 years Able to follow verbal instructions related to the visual feedback training. MMSE score >21 Modified Ashworth scale (MAS) level 1-3 Brunnstrom stages 1-4 Fugyl Meyer score limit for upper limb Exclusion Criteria: Patients with Cognitive and Visual impairments Psychological disorder History of other neurological disorders Pusher's syndrome Hemineglect Abnormal synergic pattern Rheumatoid arthritis or other hand impairments
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Misbah Ghous, MSNMPT
Phone
03345695456
Email
misbah.ghous@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Hafsah Rashid, MS*
Phone
0332 7156366
Email
hafsa.rashid211@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Misbah Ghous, MSNMPT
Organizational Affiliation
Riphah International University islamabad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hafsa
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hafsa Rashid, MSNMPT*
Phone
03315165234

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of Exergaming Training With Visual Feedback Training on Upper Limb Functions in Post Stroke Patients

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