Back to resultsThe Impact of App-based Cognitive Training on Post-stroke Upper Extremity Rehabilitation
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
traditional physical therapy
mobile app-based cognitive training
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, sub-acute stroke, cognitive impairment
Eligibility Criteria
Inclusion Criteria: Patients aged 45-70 years. Both male and female gender. Patients of sub-acute stroke patients with impaired upper extremity function Stroke patients suffering from mild to moderate cognitive impairment. Patients with the ability to fulfill and comprehend commands Exclusion Criteria: Patients of neurodegenerative diseases like Parkinson's, multiple sclerosis etc. Patients suffering from any severe psychological disorder. Patients with severe contracture due to orthopedic disease of the shoulder, elbow, and wrist joints
Sites / Locations
- sir Ganga Ram Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Traditional physical therapy
The impact of app-based cognitive training
Arm Description
This group will receive conventional upper extremity rehabilitation including active and active assisted ROMs and upper extremity stretches for 30 minutes, three to five times a week for 6 weeks.
The experimental group received mobile-app-based cognitive training (PEAK) along with conventional upper extremity rehabilitation.
Outcomes
Primary Outcome Measures
upper extremity function
Fugl-Meyer Assessment-Upper Extremity (FMA-UE) The FMA-UE is a condition-specific outcome that applies to hemiparesis of the upper limb in stroke conditions. The FMA motor assessments for the upper (maximum score 66 points)
Trail Making Test
The Trail Making Test is a neuropsychological test of visual attention and task switching. It has two parts, in which the subject is instructed to connect a set of 25 dots as quickly as possible while maintaining accuracy. Scoring is based on time taken to complete the test (e.g. 35 seconds yielding a score of 35) with lower scores being better. Different norms are available that allow comparison with age-matched groups
Secondary Outcome Measures
Full Information
NCT ID
NCT05951530
First Posted
May 9, 2023
Last Updated
July 18, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05951530
Brief Title
The Impact of App-based Cognitive Training on Post-stroke Upper Extremity Rehabilitation
Official Title
The Impact of App-based Cognitive Training on Post-stroke Upper Extremity Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
May 10, 2023 (Actual)
Primary Completion Date
June 2, 2023 (Actual)
Study Completion Date
July 2, 2023 (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
No
5. Study Description
Brief Summary
To find out the impact of app-based cognitive training on upper extremity function in patients with sub-acute stroke.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, sub-acute stroke, cognitive impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Traditional physical therapy
Arm Type
Active Comparator
Arm Description
This group will receive conventional upper extremity rehabilitation including active and active assisted ROMs and upper extremity stretches for 30 minutes, three to five times a week for 6 weeks.
Arm Title
The impact of app-based cognitive training
Arm Type
Experimental
Arm Description
The experimental group received mobile-app-based cognitive training (PEAK) along with conventional upper extremity rehabilitation.
Intervention Type
Other
Intervention Name(s)
traditional physical therapy
Intervention Description
this group received conventional upper extremity active ROMs and stretches for 30 minutes three to five times a week for 6 weeks without using the app-based cognitive training.
Intervention Type
Other
Intervention Name(s)
mobile app-based cognitive training
Intervention Description
This group received mobile app-based cognitive training of 30minutes session three to five times a week for 6 weeks which includes a few activities such as the memory, coordination and alertness along with conventional UE exercises for 15 minutes three to five times a week for 6 weeks.
Primary Outcome Measure Information:
Title
upper extremity function
Description
Fugl-Meyer Assessment-Upper Extremity (FMA-UE) The FMA-UE is a condition-specific outcome that applies to hemiparesis of the upper limb in stroke conditions. The FMA motor assessments for the upper (maximum score 66 points)
Time Frame
4th week
Title
Trail Making Test
Description
The Trail Making Test is a neuropsychological test of visual attention and task switching. It has two parts, in which the subject is instructed to connect a set of 25 dots as quickly as possible while maintaining accuracy. Scoring is based on time taken to complete the test (e.g. 35 seconds yielding a score of 35) with lower scores being better. Different norms are available that allow comparison with age-matched groups
Time Frame
4th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 45-70 years.
Both male and female gender.
Patients of sub-acute stroke patients with impaired upper extremity function
Stroke patients suffering from mild to moderate cognitive impairment.
Patients with the ability to fulfill and comprehend commands
Exclusion Criteria:
Patients of neurodegenerative diseases like Parkinson's, multiple sclerosis etc.
Patients suffering from any severe psychological disorder.
Patients with severe contracture due to orthopedic disease of the shoulder, elbow, and wrist joints
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Binash Afzal, PHD*
Organizational Affiliation
Riphah international university lahore campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
sir Ganga Ram Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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26505981
Citation
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The Impact of App-based Cognitive Training on Post-stroke Upper Extremity Rehabilitation
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