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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05673421
Other study ID # Hafsa Rashid
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 10, 2023
Est. completion date June 2023

Study information

Verified date February 2023
Source Riphah International University
Contact Misbah Ghous, MSNMPT
Phone 03345695456
Email misbah.ghous@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date June 2023
Est. primary completion date June 2023
Accepts healthy volunteers No
Gender All
Age group 40 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exergaming Training
VR game-assisted intervention will perform for 30-45 min, 5 sessions per week for a duration of 8 weeks
Visual Feedback Training
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.

Locations

Country Name City State
Pakistan Hafsa Rawalpindi Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
2 months
Primary 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
2 months
Primary 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
2 months
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