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NCT Number: NCT06696885

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

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.

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Key information

Conditions

Chronic Stroke Patients

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah International University

Lahore, Punjab Province, 54770, Pakistan

Location status: Recruiting

Location contact

Binash Afzal, PhD

CONTACT

[email protected]

+923434539092

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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.

Treatment and study plan

Mobile based video games and task based training

Other

The experimental group received a mobile-based applications for 20 minutes and tasks-based training for 20 minutes per day (a total of 40 minutes), 6 days a week for 17 weeks. The time between each game was divided accordingly to work on improving hand function. The games and tasks were divided into three broad categories, Easy, Moderate, Difficult. Each category is applied for 6 weeks

Primary outcomes

  1. • Fugl Meyer Assessment -UE (FM-UE)

    Time frame: 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)

  2. Game User Experience Satisfaction Scale (GUESS)

    Time frame: 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.

  3. Exercise Adherence Rating Scale (EARS)

    Time frame: 6 weeks

    EARS is a tool designed to assess an individual's commitment to a prescribed exercise program.

  4. Box and Block Test (BBT)

    Time frame: 6 weeks

    Box and Block Test (BBT) measures manual dexterity by counting how many blocks a participant can transfer between compartments in 60 seconds

Study contacts

Contact information is provided by the study sponsor or research team.

Maira Sohail, MS- NMPT

CONTACT

[email protected]

+923244009200

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Combined Effects of Mobile Based Video Games and Face to Face Exercise Program on Exercise Adherence and Hand Function in Chronic Stroke.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 20, 2024
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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