Mobile Applications for Exercise Adherence and Hand Function in Chronic Stroke.

Not Applicable

Recruiting

• Conditions: Chronic Stroke Patients

• Registration Number: NCT06696885
• Lead Sponsor: Riphah International University

Brief Summary

Stroke is a clinically defined syndrome characterized by an acute, focal neurological deficit due to vascular damage in the central nervous system. It is the second leading cause of death and disability globally. Stroke is not a singular disease but results from a variety of risk factors, disease processes, and mechanisms. Following a stroke, upper limb (UL) dysfunction affects 40-50% of individuals in the chronic phase, significantly impacting their ability to perform daily tasks. The latest trend in therapy involves the use of mobile video games within rehabilitation programs. These applications leverage the multi-touch interface of mobile devices to provide accurate monitoring of a patient's health status. Many of these mobile games are specifically designed to offer therapeutic tools that enhance dexterity and improve adherence to exercise routines.

Detailed Description

A Randomized Clinical Trail (RCT) design will be employed, conducted at Johar Pain Relief center over 10 months following the synopsis approval. The anticipated sample size, accounting for a 20% attrition rate will be 32 participants in each of the study groups. Group A will recieve mobile based video games along with task based therapy for exercise adherence and hand function while Group B will recieve conventional physical therapy. The sampling technique will be non probability convenience sampling with inclusion criteria of including chronic stroke patients aged between 30 to 75 years, both male and female genders are included in the study. The data collection tools include National Institute of Health Stroke Scale (NIHSS) , Fugl Meyer Assessment -UE (FM-UE) , Game User Experience Satisfaction Scale (GUESS) , Exercise Adherence Rating Scale (Ears) and Box and Block test was applied. The analysis will be conducted using SPSS for windows software version 25. Training session will last for 6 weeks which will be conducted 6 days a week. Mobile based video games and task based training will focus on exercise adherence and hand function, mainly focusing on hand dexterity.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2023-01-12
• Status Verified: 2024-11
• Primary Completion: 2024-11
• Study Completion: 2024-11
• Study First Submitted: 2024-11-18
• Study First Submitted QC: 2024-11-18
• Last Update Submitted: 2024-11-18
• Study First Posted: 2024-11-20
• Last Update Posted: 2024-11-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Male and female patients age 30 to 75 years were included.
• Chronic stroke patients ranging from 6 months to 2 years (41).
• Participants having a stroke severity score > 6 on National Institute of Health Stroke Scale (NIHSS) (42).
• Modified Ashworth scale score ≤ 3 of the affected upper extremity (44).
• Montreal Cognitive Assessment (MoCA) score ≥ 26 (45).
• Patients who are able to sit without support.
• No contractures of the affected wrist and fingers.

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Exclusion Criteria

• Participants who show the symptoms of global or receptive aphasia.
• Participants who have medical problems or co-morbidities that interdict their participation in the study (such as shoulder pain in the paretic limb).
• Patients with severe apraxia, somatosensory problems.
• Severe spasticity of the affected wrist and finger flexors.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
• Fugl Meyer Assessment -UE (FM-UE)	6 weeks	FMA(UE) is a assessment tool for upper extremity which is divided into 5 domains (motor, sensory, balance, range of motion, and pain)
Game User Experience Satisfaction Scale (GUESS)	6 weeks	GUESS evaluates patient satisfaction of video-games following their participation in the gamified intervention. The GUESS consists of 55 items with 9 subscales. The subscales include usability/playability, narratives, play engrossment, enjoyment, creative freedom, audio aesthetics, personal gratification, social connectivity and visual aesthetics.
Exercise Adherence Rating Scale (EARS)	6 weeks	EARS is a tool designed to assess an individual's commitment to a prescribed exercise program.
Box and Block Test (BBT)	6 weeks	Box and Block Test (BBT) measures manual dexterity by counting how many blocks a participant can transfer between compartments in 60 seconds

Trial Locations

Locations (1)

Riphah International University; 🇵🇰 Lahore, Punjab, Pakistan