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

November 18, 2024 updated by: Riphah International University

Combined Effects of Mobile Based Video Games and Face to Face Exercise Program on 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54770
        • Recruiting
        • Riphah International University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A
Group A received mobile based video games along with task based training.
Other: 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
No Intervention: Group B
Group B received conventional physical therapy plan.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
• 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)
6 weeks
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.
6 weeks
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.
6 weeks
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
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Binish Afzal, MS-NMPT, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 12, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/RCR & AHS/24/0205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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