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

NCT ID: NCT06696885

Last Updated: 2024-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-12

Study Completion Date

2024-11-30

Brief Summary

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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

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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.

Conditions

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Chronic Stroke Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group A

Group A received mobile based video games along with task based training.

Group Type EXPERIMENTAL

Mobile based video games and task based training

Intervention Type 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

Group B

Group B received conventional physical therapy plan.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mobile based video games and task based training

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Binish Afzal, MS-NMPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Riphah International University

Lahore, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Maira Sohail, MS- NMPT

Role: CONTACT

+923244009200

Facility Contacts

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Binash Afzal, PhD

Role: primary

+923434539092

References

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Sulfikar Ali A, Arumugam A, Kumaran D S. Effectiveness of an intensive, functional, gamified Rehabilitation program in improving upper limb motor function in people with stroke: A protocol of the EnteRtain randomized clinical trial. Contemp Clin Trials. 2021 Jun;105:106381. doi: 10.1016/j.cct.2021.106381. Epub 2021 Apr 20.

Reference Type BACKGROUND
PMID: 33862286 (View on PubMed)

Other Identifiers

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REC/RCR & AHS/24/0205

Identifier Type: -

Identifier Source: org_study_id

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