Clinical trial NCT06696885: Mobile Applications for Exercise Adherence and Hand Function in Chronic Stroke.
Official title: Combined Effects of Mobile Based Video Games and Face to Face Exercise Program on Exercise Adherence and Hand Function in Chronic Stroke.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Stroke Patients
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 32
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: • Fugl Meyer Assessment -UE (FM-UE)
timeFrame: 6 weeks
measure: Game User Experience Satisfaction Scale (GUESS)
timeFrame: 6 weeks
measure: Exercise Adherence Rating Scale (EARS)
timeFrame: 6 weeks
measure: Box and Block Test (BBT)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Binish Afzal, MS-NMPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.