- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05951530
The Impact of App-based Cognitive Training on Post-stroke Upper Extremity Rehabilitation
July 18, 2023 updated by: Riphah International University
To find out the impact of app-based cognitive training on upper extremity function in patients with sub-acute stroke.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- Sir Ganga Ram Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Traditional physical therapy
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.
|
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.
|
|
Experimental: The impact of app-based cognitive training
The experimental group received mobile-app-based cognitive training (PEAK) along with conventional upper extremity rehabilitation.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
upper extremity function
Time Frame: 4th week
|
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)
|
4th week
|
|
Trail Making Test
Time Frame: 4th week
|
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
|
4th week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Binash Afzal, PHD*, Riphah International University Lahore Campus
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Levin MF, Kleim JA, Wolf SL. What do motor "recovery" and "compensation" mean in patients following stroke? Neurorehabil Neural Repair. 2009 May;23(4):313-9. doi: 10.1177/1545968308328727. Epub 2008 Dec 31.
- Feigin VL, Krishnamurthi RV, Parmar P, Norrving B, Mensah GA, Bennett DA, Barker-Collo S, Moran AE, Sacco RL, Truelsen T, Davis S, Pandian JD, Naghavi M, Forouzanfar MH, Nguyen G, Johnson CO, Vos T, Meretoja A, Murray CJ, Roth GA; GBD 2013 Writing Group; GBD 2013 Stroke Panel Experts Group. Update on the Global Burden of Ischemic and Hemorrhagic Stroke in 1990-2013: The GBD 2013 Study. Neuroepidemiology. 2015;45(3):161-76. doi: 10.1159/000441085. Epub 2015 Oct 28.
- Kim YD, Jung YH, Saposnik G. Traditional Risk Factors for Stroke in East Asia. J Stroke. 2016 Sep;18(3):273-285. doi: 10.5853/jos.2016.00885. Epub 2016 Sep 30.
- Nomani AZ, Nabi S, Badshah M, Ahmed S. Review of acute ischaemic stroke in Pakistan: progress in management and future perspectives. Stroke Vasc Neurol. 2017 Feb 24;2(1):30-39. doi: 10.1136/svn-2016-000041. eCollection 2017 Mar.
- Langhorne P, Legg L. Evidence behind stroke rehabilitation. J Neurol Neurosurg Psychiatry. 2003 Dec;74 Suppl 4(Suppl 4):iv18-iv21. doi: 10.1136/jnnp.74.suppl_4.iv18. No abstract available.
- Engfeldt B, Hultenby K, Muller M. Ultrastructure of hyaline cartilage. I. A comparative study of cartilage from different species and locations, using cryofixation, freeze-substitution and low-temperature embedding techniques. Acta Pathol Microbiol Immunol Scand A. 1986 Sep;94(5):313-23.
- Tang EY, Amiesimaka O, Harrison SL, Green E, Price C, Robinson L, Siervo M, Stephan BC. Longitudinal Effect of Stroke on Cognition: A Systematic Review. J Am Heart Assoc. 2018 Jan 15;7(2):e006443. doi: 10.1161/JAHA.117.006443.
- Pinter D, Enzinger C, Gattringer T, Eppinger S, Niederkorn K, Horner S, Fandler S, Kneihsl M, Krenn K, Bachmaier G, Fazekas F. Prevalence and short-term changes of cognitive dysfunction in young ischaemic stroke patients. Eur J Neurol. 2019 May;26(5):727-732. doi: 10.1111/ene.13879. Epub 2019 Jan 9.
- McDonald MW, Black SE, Copland DA, Corbett D, Dijkhuizen RM, Farr TD, Jeffers MS, Kalaria RN, Karayanidis F, Leff AP, Nithianantharajah J, Pendlebury S, Quinn TJ, Clarkson AN, O'Sullivan MJ. Cognition in stroke rehabilitation and recovery research: Consensus-based core recommendations from the second Stroke Recovery and Rehabilitation Roundtable. Int J Stroke. 2019 Oct;14(8):774-782. doi: 10.1177/1747493019873600. Epub 2019 Sep 12.
- Wiley E, Khattab S, Tang A. Examining the effect of virtual reality therapy on cognition post-stroke: a systematic review and meta-analysis. Disabil Rehabil Assist Technol. 2022 Jan;17(1):50-60. doi: 10.1080/17483107.2020.1755376. Epub 2020 May 2.
- Fruhwirth V, Enzinger C, Fandler-Hofler S, Kneihsl M, Eppinger S, Ropele S, Schmidt R, Gattringer T, Pinter D. Baseline white matter hyperintensities affect the course of cognitive function after small vessel disease-related stroke: a prospective observational study. Eur J Neurol. 2021 Feb;28(2):401-410. doi: 10.1111/ene.14593. Epub 2020 Nov 12.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 10, 2023
Primary Completion (Actual)
June 2, 2023
Study Completion (Actual)
July 2, 2023
Study Registration Dates
First Submitted
May 9, 2023
First Submitted That Met QC Criteria
July 18, 2023
First Posted (Actual)
July 19, 2023
Study Record Updates
Last Update Posted (Actual)
July 19, 2023
Last Update Submitted That Met QC Criteria
July 18, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/23/0207
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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