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

NCT06696885 | Recruiting

• 1 other identifier: REC/RCR & AHS/24/0205
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Stroke Patients

Outcome Measures

Primary Outcomes (4)

• • Fugl Meyer Assessment -UE (FM-UE)

  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)

  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)

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

  6 weeks

• Box and Block Test (BBT)

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

  6 weeks

Study Arms (2)

Group A

EXPERIMENTAL

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

Other: Mobile based video games and task based training

Group B

NO INTERVENTION

Group B received conventional physical therapy plan.

Interventions

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

Group A

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54770, Pakistan

RECRUITING

Related Publications (1)

• 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 BACKGROUND

Study Officials

• Binish Afzal, MS-NMPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maira Sohail, MS- NMPT

CONTACT

+923244009200; mairasohail01@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 20, 2024
• Study Start: January 12, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)