NCT05425082

Brief Summary

The purpose of the study is to find out the comparison of motor relearning and neurodevelopmental therapy on motor performance and quality of life in stroke patients.As motor relearning program and neurodevelopmental therapy have different effects on lower limb motor functions and quality of life. Therefore, there is need to find out the best treatment approach either MRP, neurodevelopmental therapy or both to improve motor function of lower limb and quality of life as it will help the patient to gain functional independency. This study will provide the health professionals the evidence to use these techniques according to patient interest in the clinical setup.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Apr 2022

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

Study Start

First participant enrolled

April 4, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2022

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

5 months

First QC Date

June 15, 2022

Last Update Submit

January 28, 2024

Conditions

Keywords

Stroke

Outcome Measures

Primary Outcomes (3)

  • Fugl Meyer Assessment Scale

    Use: The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.

    6th week

  • Modified Barthel Index

    Use: The MBI was used to measure functional performance in basic activities of daily living (ADL).

    6th week

  • TIME UP AND GO TEST

    Use: The 'timed up and go' test (TUG) is a simple, quick and widely used clinical performance-based measure of lower extremity function, mobility and fall risk.

    6th week

Study Arms (2)

Motor relearning program

ACTIVE COMPARATOR

Emphasis of MRP is on practice of specific activities, the training of cognitive control over muscles \& movement. Components of activities \& conscious elimination of unnecessary muscle activity.• Based on 3 factors - 1. Elimination of unnecessary muscle activity 2. Feedback 3. Practice

Other: Motor relearning program

Neurodevelopmental therapy

EXPERIMENTAL

The abnormal patterns must be stopped not by modifying the sensory input, but by giving back to the patient the • The hemiplegic side should be incorporated into all treatment activities to reestablish symmetry and increased functional use * Treatment should produce a change in the quality of movement and functional performance of the involved side * Increase active use of the involved side * Provide practice to improve motor performance that led to motor learning lost or undeveloped control over his output in developmental sequence

Other: Neurodevelopmental therapy

Interventions

Treatment session of one hour per day for five days a week, for four weeks for each participant until 20 sessions

Motor relearning program

Treatment session of one hour per day for five days a week, for four weeks for each participant until 20 sessions.

Neurodevelopmental therapy

Eligibility Criteria

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

You may qualify if:

  • Both male and female, with age between 45-70 years
  • First-time unilateral stroke confirmed by magnetic resonance imaging or computed axial tomography scan.
  • Clinically stable with fully oriented and conscious.
  • Subacute stroke patients.
  • Patients having lower limb dysfunction.
  • Patients with Mini Mental State Examination MMSE score ≥ 24

You may not qualify if:

  • Recurrent stroke.
  • Foot drop
  • Cardiac disease that limit function by exertional dyspnea, angina or severe fatigue.
  • Any visual and hearing problem
  • Subarachnoid or extradural hemorrhage, progressive hydrocephalus, previous history of brain injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chughtai Rehabilitation Centre

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (12)

  • Goyal M, Demchuk AM, Menon BK, Eesa M, Rempel JL, Thornton J, Roy D, Jovin TG, Willinsky RA, Sapkota BL, Dowlatshahi D, Frei DF, Kamal NR, Montanera WJ, Poppe AY, Ryckborst KJ, Silver FL, Shuaib A, Tampieri D, Williams D, Bang OY, Baxter BW, Burns PA, Choe H, Heo JH, Holmstedt CA, Jankowitz B, Kelly M, Linares G, Mandzia JL, Shankar J, Sohn SI, Swartz RH, Barber PA, Coutts SB, Smith EE, Morrish WF, Weill A, Subramaniam S, Mitha AP, Wong JH, Lowerison MW, Sajobi TT, Hill MD; ESCAPE Trial Investigators. Randomized assessment of rapid endovascular treatment of ischemic stroke. N Engl J Med. 2015 Mar 12;372(11):1019-30. doi: 10.1056/NEJMoa1414905. Epub 2015 Feb 11.

    PMID: 25671798BACKGROUND
  • Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.

    PMID: 21571152BACKGROUND
  • Ng YS, Stein J, Ning M, Black-Schaffer RM. Comparison of clinical characteristics and functional outcomes of ischemic stroke in different vascular territories. Stroke. 2007 Aug;38(8):2309-14. doi: 10.1161/STROKEAHA.106.475483. Epub 2007 Jul 5.

    PMID: 17615368BACKGROUND
  • Ernst E. A review of stroke rehabilitation and physiotherapy. Stroke. 1990 Jul;21(7):1081-5. doi: 10.1161/01.str.21.7.1081.

    PMID: 2195716BACKGROUND
  • Chan DY, Chan CC, Au DK. Motor relearning programme for stroke patients: a randomized controlled trial. Clin Rehabil. 2006 Mar;20(3):191-200. doi: 10.1191/0269215506cr930oa.

    PMID: 16634338BACKGROUND
  • Sheffler LR, Taylor PN, Gunzler DD, Buurke JH, Ijzerman MJ, Chae J. Randomized controlled trial of surface peroneal nerve stimulation for motor relearning in lower limb hemiparesis. Arch Phys Med Rehabil. 2013 Jun;94(6):1007-14. doi: 10.1016/j.apmr.2013.01.024. Epub 2013 Feb 8.

    PMID: 23399456BACKGROUND
  • Hafsteinsdottir TB, Algra A, Kappelle LJ, Grypdonck MH; Dutch NDT Study Group. Neurodevelopmental treatment after stroke: a comparative study. J Neurol Neurosurg Psychiatry. 2005 Jun;76(6):788-92. doi: 10.1136/jnnp.2004.042267.

    PMID: 15897499BACKGROUND
  • Rudberg AS, Berge E, Laska AC, Jutterstrom S, Nasman P, Sunnerhagen KS, Lundstrom E. Stroke survivors' priorities for research related to life after stroke. Top Stroke Rehabil. 2021 Mar;28(2):153-158. doi: 10.1080/10749357.2020.1789829. Epub 2020 Jul 5.

    PMID: 32627722BACKGROUND
  • Pathak A, Gyanpuri V, Dev P, Dhiman NR. The Bobath Concept (NDT) as rehabilitation in stroke patients: A systematic review. J Family Med Prim Care. 2021 Nov;10(11):3983-3990. doi: 10.4103/jfmpc.jfmpc_528_21. Epub 2021 Nov 29.

    PMID: 35136756BACKGROUND
  • Yeh CY, Schulien AJ, Molyneaux BJ, Aizenman E. Lessons from Recent Advances in Ischemic Stroke Management and Targeting Kv2.1 for Neuroprotection. Int J Mol Sci. 2020 Aug 25;21(17):6107. doi: 10.3390/ijms21176107.

    PMID: 32854248BACKGROUND
  • Oyake K, Suzuki M, Otaka Y, Tanaka S. Motivational Strategies for Stroke Rehabilitation: A Descriptive Cross-Sectional Study. Front Neurol. 2020 Jun 10;11:553. doi: 10.3389/fneur.2020.00553. eCollection 2020.

    PMID: 32587572BACKGROUND
  • Pandian S, Arya KN, Davidson EWR. Comparison of Brunnstrom movement therapy and Motor Relearning Program in rehabilitation of post-stroke hemiparetic hand: a randomized trial. J Bodyw Mov Ther. 2012 Jul;16(3):330-337. doi: 10.1016/j.jbmt.2011.11.002. Epub 2011 Dec 6.

    PMID: 22703742BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Binash Afzal, PHD*

    Riphah international university lahore campus

    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

June 15, 2022

First Posted

June 21, 2022

Study Start

April 4, 2022

Primary Completion

September 15, 2022

Study Completion

November 15, 2022

Last Updated

January 30, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations