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AzTrials

StrokeNCT05951530

The Impact of App-based Cognitive Training on Post-stroke Upper Extremity Rehabilitation

A study testing traditional physical therapy and mobile app-based cognitive training in people with Stroke, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To find out the impact of app-based cognitive training on upper extremity function in patients with sub-acute stroke. Read more about this study

Who is it for?
Ages 45 to 70 years
Conditions the study is for
Stroke
What is being tested?
traditional physical therapy and mobile app-based cognitive training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 sitePakistan
Study dates
10 May 2023to 2 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • sir Ganga Ram Hospital

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

To find out the impact of app-based cognitive training on upper extremity function in patients with sub-acute stroke.

Conditions
Stroke
Being tested
traditional physical therapy, mobile app-based cognitive training
Keywords
stroke, sub-acute stroke, cognitive impairment
Medical subject headings
Stroke, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • traditional physical therapyOther

    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.

  • mobile app-based cognitive trainingOther

    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.

Study groups in NCT05951530
Study groupRoleWhat they receive
Traditional physical therapyActive comparatorThis 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.
Receives: Other: traditional physical therapy
The impact of app-based cognitive trainingExperimentalThe experimental group received mobile-app-based cognitive training (PEAK) along with conventional upper extremity rehabilitation.
Receives: Other: mobile app-based cognitive training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 4th week

  2. 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

    Measured: 4th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2023
  2. Study start10 May 2023
  3. Primary completion2 Jun 2023
  4. Study completion2 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05951530
Sponsor's protocol ID
REC/RCR&AHS/23/0207
Status last verified
Jul 2023
First submitted
9 May 2023
Last updated
19 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26505981

  • 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.

    PubMed 27733028

  • 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.

    PubMed 28959488

  • 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.

    PubMed 14645462

  • 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.

    PubMed 19118128

  • 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.

    PubMed 3532690

  • 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.

    PubMed 29335318

  • 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.

    PubMed 30489673

  • 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.

    PubMed 31514685

  • 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.

    PubMed 32363955

  • 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.

    PubMed 33065757

Questions about this trial

What is this clinical trial studying?

A study testing traditional physical therapy and mobile app-based cognitive training in people with Stroke, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

upper extremity function (time frame: 4th week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05951530, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023.

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