Smartphone Rehabilitation App For Stroke Survivor

Sponsor

Riphah International University (Other)

Overall Status

Completed

CT.gov ID

NCT05139550

Collaborator

(none)

Enrollment

Location

Arm

3.1

Actual Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: Smartphone Rehabilitation Application	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Smartphone Rehabilitation App For Stroke Survivor

Actual Study Start Date :

Nov 21, 2021

Actual Primary Completion Date :

Jan 30, 2022

Actual Study Completion Date :

Feb 22, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Wolf Motor Function Test (WMFT) [4 weeks]
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.
Nine-Hole Peg Test (9HPT) [4 weeks]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Riphah International University	Rawalpindi	Punjab	Pakistan

Sponsors and Collaborators

Riphah International University

Investigators

Study Chair: Aruba Saeed, PhD*, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Riphah International University

ClinicalTrials.gov Identifier:

NCT05139550

Other Study ID Numbers:

REC/00828 Rabiya Tahir

First Posted:

Dec 1, 2021

Last Update Posted:

Apr 18, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Riphah International University

stroke

CVA

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Apr 18, 2022