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Smartphone Rehabilitation App For Stroke Survivor

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Smartphone Rehabilitation Application
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, CVA

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Riphah International University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Smartphone Rehabilitation Application

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Full Information

First Posted
October 26, 2021
Last Updated
April 15, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05139550
Brief Title
Smartphone Rehabilitation App For Stroke Survivor
Official Title
Smartphone Rehabilitation App For Stroke Survivor
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 21, 2021 (Actual)
Primary Completion Date
January 30, 2022 (Actual)
Study Completion Date
February 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, CVA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Smartphone Rehabilitation Application
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Smartphone Rehabilitation Application
Intervention Description
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
Primary Outcome Measure Information:
Title
Wolf Motor Function Test (WMFT)
Description
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.
Time Frame
4 weeks
Title
Nine-Hole Peg Test (9HPT)
Description
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
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aruba Saeed, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Study Chair
Facility Information:
Facility Name
Riphah International University
City
Rawalpindi
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Smartphone Rehabilitation App For Stroke Survivor

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