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Recruiting NCT06696885

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

No phase Interventional Chronic Stroke Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mobile based video games and task based training.
Who it may be relevant to
Registry conditions: Chronic Stroke Patients. Basic parameters: 35 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • • Fugl Meyer Assessment -UE (FM-UE) [Time frame: 6 weeks]
  • Game User Experience Satisfaction Scale (GUESS) [Time frame: 6 weeks]
  • Exercise Adherence Rating Scale (EARS) [Time frame: 6 weeks]
  • Box and Block Test (BBT) [Time frame: 6 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Riphah International University — Lahore

Publications

  • 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. PMID 33862286

Identifiers

NCT: NCT06696885 · REC/RCR & AHS/24/0205

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗