NCT05139550

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2021

Completed
26 days until next milestone

Study Start

First participant enrolled

November 21, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2022

Completed
Last Updated

April 18, 2022

Status Verified

April 1, 2022

Enrollment Period

2 months

First QC Date

October 26, 2021

Last Update Submit

April 15, 2022

Conditions

Keywords

strokeCVA

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Smartphone Rehabilitation Application

EXPERIMENTAL

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

Interventions

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

Smartphone Rehabilitation Application

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Rawalpindi, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Aruba Saeed, PhD*

    Riphah International University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2021

First Posted

December 1, 2021

Study Start

November 21, 2021

Primary Completion

January 30, 2022

Study Completion

February 22, 2022

Last Updated

April 18, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations