NCT05158543

Brief Summary

According to the World Health Organization (WHO), stroke is defined as "rapidly developing clinical signs of focal (or global) disturbance of cerebral function, with symptoms lasting 24 hours or longer or leading to death, with no apparent cause other than of vascular origin". By applying this definition, transient ischemic attack (TIA), which is defined to last less than 24 hours, and patients with stroke symptoms caused by subdural hemorrhage, tumors, poisoning, or trauma, are excluded.Task-oriented training (TOT) involves active training of motor tasks performed within a clear functional context that includes complex whole task or pre-task movements of the whole limb or a limb segment. A high number of repetitions performed within a single session characterizes this training. According to the literature, TOT results in neuroplastic changes and is critical for improving motor and functional recovery. Task-specific training is based fundamentally on the concept that repeated practice results in learning a specific task. There is increasing evidence of neural plastic changes associated with repeated training, and several aspects of rehabilitation entail repetition of movement. Repeated motor practice has been demonstrated to decrease muscle weakness and spasticity and form the physiological foundation of motor learning. Repeated practice of challenging movement tasks results in larger brain representations of the practiced movement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jan 2023

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

December 13, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 15, 2021

Completed
1 year until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2024

Completed
Last Updated

May 29, 2024

Status Verified

May 1, 2024

Enrollment Period

1.3 years

First QC Date

December 13, 2021

Last Update Submit

May 26, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • Fugl-Meyer Assessment (FMA)

    Stroke-specific, performance-based impairment index. It assesses motor functioning, balance, sensation, and joint functioning in patients with post-stroke hemiplegia. The scale is comprised of five domains and there are 155 items in total: Motor functioning (in the upper and lower extremities), Sensory functioning (evaluates light touch on two surfaces of the arm and leg, and position sense for 8 joints), Balance (contains 7 tests, 3 seated and 4 standing), Joint range of motion (8 joints), Joint pain.

    week 12

  • Wolf Motor Function Test

    The Wolf Motor Function Test (WMFT) quantifies the motor function of the upper extremity (UE) through timed and functional tasks. The widely used version of the WMFT consists of 17 items. The first 6 items involve timed functional tasks, items 7 and 14 are measures of strength, and the remaining 9 items comprise analyzing movement quality when completing various tasks.

    week 12

  • Time up and go test

    The Timed Up and Go Test (TUG) is an objective clinical measure for assessing functional mobility and balance, and thus the risk of falling. The TUG measures the time taken for an individual to rise from a chair, walk 3 meters, turn, walk back and sit down.

    week 12

  • Berg balance scale (BBS)

    The Berg Balance Scale assesses the balance of patients with different neurological disorders. A subject's performance on each task is graded with a 5- point ordinal scale ranging from 0 to 4, with higher scores awarded because of speed, stability, or help required for completion of the task. It summed the task scores to give a total BBS score out of a possible 56 points with higher scores representing better balance.

    week 12

  • Wisconsin gait scale

    The Wisconsin Gait Scale (WGS) can be used to evaluate the gait problems experienced by a patient with hemiplegia following stroke. Interpretation: * minimum score: 13.35 * maximum score: 42 * The higher the score the more seriously affected the gait

    week 12

Secondary Outcomes (2)

  • Montreal Cognitive Assessment (MoCA)

    week 12

  • Stroke- Specific Quality of life SS (QOL)

    week 12

Study Arms (3)

Control Group

ACTIVE COMPARATOR

the control group will receive conventional intervention for upper and lower limb motor function \& balance.

Other: conventional therapy

moderate intensity group

EXPERIMENTAL

this group will get task-oriented training with moderate intensity using Functional activities specific training-table (FAST-Table) with 100 functional tasks.

Other: Task oriented training (moderate intensity)

high intensity group

EXPERIMENTAL

this group will get task-oriented training with high intensity using Functional activities specific training-table (FAST-Table) with 100 functional tasks.

Other: Task oriented training (high intensity)

Interventions

The conventional group will receive active and passive range of motion exercises, balance, and strength training for upper and lower limbs. One session per day, three sessions/week for total of 12 weeks.

Control Group

In the moderate-intensity group, patients will perform 100 functional tasks with a total (1000) repetitions. Single session/day, 4 sessions/week for 12 weeks.

moderate intensity group

In the moderate-intensity group, patients will perform 100 functional tasks with a total (1000) repetitions. Two sessions/day, 5 sessions/week for 12 weeks.

high intensity group

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both Genders
  • Age between 40-60 years.
  • ≥3 months post stroke.
  • Middle \& anterior Cerebral Artery stroke
  • points Mild cognitive impairment Montreal Cognitive Assessment (MoCA)
  • FMA UE and LE collectively motor score 50-70
  • Modified Rankin scale 3-4

You may not qualify if:

  • Inability to follow 2-step commands
  • Ashworth scale 3-4
  • Current participation in other stroke treatments
  • Other neurological diagnoses, history of fall \& fractures
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Rawalpindi, 64400, Pakistan

Location

Related Publications (14)

  • The World Health Organization MONICA Project (monitoring trends and determinants in cardiovascular disease): a major international collaboration. WHO MONICA Project Principal Investigators. J Clin Epidemiol. 1988;41(2):105-14. doi: 10.1016/0895-4356(88)90084-4.

    PMID: 3335877BACKGROUND
  • Krishnamurthi RV, Moran AE, Forouzanfar MH, Bennett DA, Mensah GA, Lawes CM, Barker-Collo S, Connor M, Roth GA, Sacco R, Ezzati M, Naghavi M, Murray CJ, Feigin VL; Global Burden of Diseases, Injuries, and Risk Factors 2010 Study Stroke Expert Group. The global burden of hemorrhagic stroke: a summary of findings from the GBD 2010 study. Glob Heart. 2014 Mar;9(1):101-6. doi: 10.1016/j.gheart.2014.01.003.

    PMID: 25432119BACKGROUND
  • Watkins KE, Levack WMM, Rathore FA, Hay-Smith EJC. What would 'upscaling' involve? A qualitative study of international variation in stroke rehabilitation. BMC Health Serv Res. 2021 Apr 29;21(1):399. doi: 10.1186/s12913-021-06293-8.

    PMID: 33926440BACKGROUND
  • Das SK, Banerjee TK, Biswas A, Roy T, Raut DK, Mukherjee CS, Chaudhuri A, Hazra A, Roy J. A prospective community-based study of stroke in Kolkata, India. Stroke. 2007 Mar;38(3):906-10. doi: 10.1161/01.STR.0000258111.00319.58. Epub 2007 Feb 1.

    PMID: 17272773BACKGROUND
  • Thornton J. Stroke: "striking reductions" are seen in number of people with symptoms seeking help. BMJ. 2020 Apr 6;369:m1406. doi: 10.1136/bmj.m1406. No abstract available.

    PMID: 32253176BACKGROUND
  • Farooq MU, Majid A, Reeves MJ, Birbeck GL. The epidemiology of stroke in Pakistan: past, present, and future. Int J Stroke. 2009 Oct;4(5):381-9. doi: 10.1111/j.1747-4949.2009.00327.x.

    PMID: 19765127BACKGROUND
  • Syed NA, Khealani BA, Ali S, Hasan A, Akhtar N, Brohi H, Mozaffar T, Ahmed N, Hameed A, Baig SM, Wasay M. Ischemic stroke subtypes in Pakistan: the Aga Khan University Stroke Data Bank. J Pak Med Assoc. 2003 Dec;53(12):584-8.

    PMID: 14765937BACKGROUND
  • Diaz-Arribas MJ, Martin-Casas P, Cano-de-la-Cuerda R, Plaza-Manzano G. Effectiveness of the Bobath concept in the treatment of stroke: a systematic review. Disabil Rehabil. 2020 Jun;42(12):1636-1649. doi: 10.1080/09638288.2019.1590865. Epub 2019 Apr 24.

    PMID: 31017023BACKGROUND
  • Ko EJ, Sung IY, Moon HJ, Yuk JS, Kim HS, Lee NH. Effect of Group-Task-Oriented Training on Gross and Fine Motor Function, and Activities of Daily Living in Children with Spastic Cerebral Palsy. Phys Occup Ther Pediatr. 2020;40(1):18-30. doi: 10.1080/01942638.2019.1642287. Epub 2019 Jul 24.

    PMID: 31339403BACKGROUND
  • Winstein C, Kim B, Kim S, Martinez C, Schweighofer N. Dosage Matters. Stroke. 2019 Jul;50(7):1831-1837. doi: 10.1161/STROKEAHA.118.023603. Epub 2019 Jun 5.

    PMID: 31164067BACKGROUND
  • Tollar J, Nagy F, Csutoras B, Prontvai N, Nagy Z, Torok K, Blenyesi E, Vajda Z, Farkas D, Toth BE, Repa I, Moizs M, Sipos D, Kedves A, Kovacs A, Hortobagyi T. High Frequency and Intensity Rehabilitation in 641 Subacute Ischemic Stroke Patients. Arch Phys Med Rehabil. 2021 Jan;102(1):9-18. doi: 10.1016/j.apmr.2020.07.012. Epub 2020 Aug 27.

    PMID: 32861668BACKGROUND
  • Borschmann K, Hayward KS, Raffelt A, Churilov L, Kramer S, Bernhardt J. Rationale for Intervention and Dose Is Lacking in Stroke Recovery Trials: A Systematic Review. Stroke Res Treat. 2018 Oct 30;2018:8087372. doi: 10.1155/2018/8087372. eCollection 2018.

    PMID: 30515288BACKGROUND
  • Lin SH, Dionne TP. Interventions to Improve Movement and Functional Outcomes in Adult Stroke Rehabilitation: Review and Evidence Summary. J Particip Med. 2018 Jan 18;10(1):e3. doi: 10.2196/jopm.8929.

    PMID: 33052128BACKGROUND
  • Afridi A, Malik AN, Rathore FA. High-Intensity Functional Activities Specific Training (FAST) in Post-Stroke Rehabilitation: A Randomized Trial on Motor Recovery and Quality of Life Improvements. Physiother Res Int. 2025 Apr;30(2):e70064. doi: 10.1002/pri.70064.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Arshad Nawaz Malik, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2021

First Posted

December 15, 2021

Study Start

January 1, 2023

Primary Completion

April 25, 2024

Study Completion

April 25, 2024

Last Updated

May 29, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations