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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05139550
Other study ID # REC/00828 Rabiya Tahir
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 21, 2021
Est. completion date February 22, 2022

Study information

Verified date April 2022
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date February 22, 2022
Est. primary completion date January 30, 2022
Accepts healthy volunteers No
Gender All
Age group 40 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Pakistan Riphah International University Rawalpindi Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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