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StrokeNCT05425082

Comparison of Motor Relearning and Neurodevelopmental Therapy in Stroke Patients

A study testing Motor relearning program and Neurodevelopmental therapy 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

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. Read more about this study

Who is it for?
Ages 45 to 70 years
Conditions the study is for
Stroke
What is being tested?
Motor relearning program and Neurodevelopmental therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 sitePakistan
Study dates
4 Apr 2022to 15 Nov 2022
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

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Chughtai Rehabilitation Centre

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

Official title: Comparison of Motor Relearning and Neurodevelopmental Therapy on Motor Performance and Quality of Life in Stroke Patients

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.

Read the detailed description

Stroke is one of the leading causes of death and the commonest cause of long-term disability in adults. In Pakistan it is also prevalent with prevalence of 1.24%, having common risk factor hypertension, diabetes, dyslipidemia and smoking. The focus of stroke rehabilitation is largely on the recovery of impaired movements and functions as it often leads to balance impairment and impaired postural control and mobility. The diagnosis and management of acute ischemic stroke are limited by the lack of rapid diagnostic assays for use in an emergency setting. Computed tomography (CT) scanning is used to diagnose hemorrhagic stroke but quite ineffective (<33% sensitive) to diagnose ischemic stroke. Among patients with acute ischemic stroke with a proximal vessel occlusion, a small infarct core, and moderate-to-good collateral circulation, rapid endovascular treatment improved functional outcomes and reduced mortality.

Stroke is a common, serious, and disabling worldwide health-care problem and rehabilitation is a major part of patient care. Many evidences support the concept of rehabilitation of stroke which involve multidisciplinary team.Stroke have adverse effect on mobility and activity of daily livings depending upon which vessel is being effected. If ACA is involved then there will be contralateral hemiparesis and hemisensory loss more effecting the lower limb with mobility issues and dependency of stroke patients on their relatives in ADLs and if MCA involve then upper extremities will be affected with speech related impairments. Stroke patients must get rehabilitation despite of which vessel is being involved in the cerebrovascular accident CVS. Stroke patients get benefit from the physical therapy rehabilitation. A well planned rehabilitation program can reduce the catastrophic events

from stroke. Motor relearning is a specialized program rehabilitation focused on motor function recovery. Many studies have been conducted to check the effectiveness of MRP on physical performance of stroke patients. The motor relearning program has found to be useful to increase functional recovery of patients with strok. Peroneal nerve stimulation (PNS) for motor relearning have significant role in improving functional mobility and quality of life. Berta Bobath gave the concept of Bobath or neurodevelopmental therapy (NDT). Bobath therapy or neurodevelopmental therapy NDT is use as an adjunct in stroke rehabilitation which is based on the principal of encouragement of normal movement pattern and discouragement of compensatory movements (11). Bobath therapy is based on inhibition of spasticity and facilitation of normal movement. Bobath therapy has become the heart of neurorehabilitation approach.

Different strategies had been used for this purpose, which includes motor relearning program (MRP) and neurodevelopmental therapy. MRP involves active participation from patients because MRP involve relearning of functional activities that are very beneficial for patients whereas, neurodevelopmental therapy include performance that facilitated by the therapist; spasticity that was inhibited, thus permitting more normal movement.

This randomized clinical trial will recruit patients through consecutive sampling. Diagnosed patients of stroke will be included. The patients will be divided into 2 groups, 1 and 2 and MRP therapy will be given to group 1 and neurodevelopmental therapy will be given to group 2. Session of 1 hour per day for 5 days a week will be given to both groups. The study will be based on pre-test post-test assessment of patients through Fugl Meyer assessment scale, Modified Barthel Index and Time Up and Go test. The data will be analyzed using SPSS 25 version software

Conditions
Stroke
Being tested
Motor relearning program, Neurodevelopmental therapy
Keywords
Stroke
Medical subject headings
Stroke

What participants receive

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

  • Motor relearning programOther

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

  • Neurodevelopmental therapyOther

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

Study groups in NCT05425082
Study groupRoleWhat they receive
Motor relearning programActive comparatorEmphasis 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
Receives: Other: Motor relearning program
Neurodevelopmental therapyExperimentalThe 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
Receives: Other: Neurodevelopmental therapy

What is being measured

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

  1. 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.

    Measured: 6th week

  2. Modified Barthel Index

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

    Measured: 6th week

  3. 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.

    Measured: 6th week

Timeline

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

  1. First posted21 Jun 2022
  2. Study start4 Apr 2022
  3. Primary completion15 Sep 2022
  4. Study completion15 Nov 2022

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
Single blind
Who is masked
Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05425082
Sponsor's protocol ID
REC/RCR&AHS/22/0225
Status last verified
Jan 2024
First submitted
15 Jun 2022
Last updated
30 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

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

    PubMed 21571152
  • 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.

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

    PubMed 2195716
  • 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.

    PubMed 16634338
  • 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.

    PubMed 23399456
  • 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.

    PubMed 15897499
  • 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.

    PubMed 32627722
  • 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.

    PubMed 35136756
  • 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.

    PubMed 32854248
  • 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.

    PubMed 32587572
  • 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.

    PubMed 22703742

Questions about this trial

What is this clinical trial studying?

A study testing Motor relearning program and Neurodevelopmental therapy 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 6 inclusion and 5 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 30 Jan 2024. 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?

Fugl Meyer Assessment Scale (time frame: 6th week). The study lists 3 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 NCT05425082, which also lists 12 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 30 Jan 2024.

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