NCT05951530

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started May 2023

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

May 9, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

May 10, 2023

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 19, 2023

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

23 days

First QC Date

May 9, 2023

Last Update Submit

July 18, 2023

Conditions

Keywords

stroke, sub-acute stroke, cognitive impairment

Outcome Measures

Primary Outcomes (2)

  • 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)

    4th week

  • 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

    4th week

Study Arms (2)

Traditional physical therapy

ACTIVE COMPARATOR

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.

Other: traditional physical therapy

The impact of app-based cognitive training

EXPERIMENTAL

The experimental group received mobile-app-based cognitive training (PEAK) along with conventional upper extremity rehabilitation.

Other: mobile app-based cognitive training

Interventions

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.

Traditional physical therapy

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.

The impact of app-based cognitive training

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

sir Ganga Ram Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (11)

  • 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.

    PMID: 26505981BACKGROUND
  • 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.

    PMID: 27733028BACKGROUND
  • 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.

    PMID: 28959488BACKGROUND
  • 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.

    PMID: 14645462BACKGROUND
  • 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.

    PMID: 19118128BACKGROUND
  • 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.

    PMID: 3532690BACKGROUND
  • 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.

    PMID: 29335318BACKGROUND
  • 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.

    PMID: 30489673BACKGROUND
  • 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.

    PMID: 31514685BACKGROUND
  • 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.

    PMID: 32363955BACKGROUND
  • 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.

    PMID: 33065757BACKGROUND

MeSH Terms

Conditions

StrokeCognitive Dysfunction

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Binash Afzal, PHD*

    Riphah international university lahore campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2023

First Posted

July 19, 2023

Study Start

May 10, 2023

Primary Completion

June 2, 2023

Study Completion

July 2, 2023

Last Updated

July 19, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations