Smartphone Rehabilitation App For Stroke Survivor

This is a pilot study of a smartphone app in which the tool will be developed and validation of the tool will be done for the rehabilitation of upper limb in stroke survivors. The study will be divided into two phases. The first phase will be the development of a smartphone app for upper limb function. The second phase of the study will be a pilot study where 10 stroke patients will be recruited and upper limb intervention will be applied through a smartphone app.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Smartphone Rehabilitation Application

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan
      • Riphah International University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subacute and chronic stroke patient > 3 months post stroke till 1 year.
• Modified Ashworth scale scoring ≤ 2
• An ability to understand the command
• First ever stroke
• Grade II, III on Functional mobility Scale
• Able to use and comprehend smart phone.

Exclusion Criteria:

• Vestibular disorders, paroxysmal vertigo
• Presence of other neurological conditions such as neglect, hemianopsia and pushing syndrome

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Smartphone Rehabilitation Application; Upper Limb Exercise Protocol: Passive Exercises ROMs for shoulder, ROMs for elbow, ROMs for wrist,fingers and thumb Active/Assisted Exercises bilateral shoulder flexion with both hands interlocked, Elbow pronation and supination, Wrist flexion and extension with the help of unaffected hand, Forearm to box, Extend elbow (side), Hand to box (front) Functional Activities Lift can, Lift pencil, Lift paper clip, Stack checkers, Flip cards, Fold towel, drinking water from a glass, lifting a glass of water to a level of 90° shoulder flexion with an extended elbow, moving 5 crystals from the table to a box, wiping the table with a towel with the elbow extended, grasping and releasing a 6 cm in diameter tennis ball, combing their hair, Eating with affected hand, opening and closing jars

Device: Smartphone Rehabilitation Application; Upper Limb Exercise Protocol: Passive Exercises ROMs for shoulder, ROMs for elbow, ROMs for wrist,fingers and thumb Active/Assisted Exercises bilateral shoulder flexion with both hands interlocked, Elbow pronation and supination, Wrist flexion and extension with the help of unaffected hand, Forearm to box, Extend elbow (side), Hand to box (front) Functional Activities Lift can, Lift pencil, Lift paper clip, Stack checkers,Flip cards, Fold towel, drinking water from a glass, lifting a glass of water to a level of 90° shoulder flexion with an extended elbow, moving 5 crystals from the table to a box, wiping the table with a towel with the elbow extended, grasping and releasing a 6 cm in diameter tennis ball, combing their hair, Eating with affected hand, opening and closing jars

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wolf Motor Function Test (WMFT)	The Wolf Motor Function Test (WMFT) quantifies upper limb motor ability through timed and functional tasks. Original WMFT contains 21 items but widely used WMFT contains 17 items. The maximum time allowed for each task is 120 seconds. Each task is rated on a 6 point scale of 0-5 0 means unable to attempt the task while 5 means normal. Lower scores indicate lower functioning levels.	4 weeks
Nine-Hole Peg Test (9HPT)	The Nine-Hole Peg Test (9HPT) is used to measure finger dexterity in various neurological conditions. Patients are scored in seconds based on the time taken to complete the activity. The stopwatch should be started from the moment the participant touches the first peg until the moment the last peg hits the container. Alternative scoring - the number of pegs placed in 50 or 100 seconds can be recorded. In this case, results are expressed as the number of pegs placed per second	4 weeks

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Study Chair: Aruba Saeed, PhD*, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2021
• Primary Completion (Actual): January 30, 2022
• Study Completion (Actual): February 22, 2022

Study Registration Dates

• First Submitted: October 26, 2021
• First Submitted That Met QC Criteria: November 18, 2021
• First Posted (Actual): December 1, 2021

Study Record Updates

• Last Update Posted (Actual): April 18, 2022
• Last Update Submitted That Met QC Criteria: April 15, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: stroke; CVA
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: REC/00828 Rabiya Tahir

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