Comparison of Motor Relearning and Neurodevelopmental Therapy in Stroke Patients

Sponsor

Riphah International University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05425082

Collaborator

(none)

Enrollment

Location

Arms

7.4

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Other: Motor relearning program Other: Neurodevelopmental therapy	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 4, 2022

Anticipated Primary Completion Date :

Sep 15, 2022

Anticipated Study Completion Date :

Nov 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Motor relearning program 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 - Elimination of unnecessary muscle activity Feedback Practice	Other: Motor relearning program Treatment session of one hour per day for five days a week, for four weeks for each participant until 20 sessions
Experimental: Neurodevelopmental therapy 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 Treatment session of one hour per day for five days a week, for four weeks for each participant until 20 sessions.

Arm

Intervention/Treatment

Active Comparator: Motor relearning program

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 - Elimination of unnecessary muscle activity Feedback Practice

Other: Motor relearning program

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

Experimental: Neurodevelopmental therapy

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

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

Outcome Measures

Primary Outcome Measures

Fugl Meyer Assessment Scale [6th week]
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. Criterion Validity: total score correlations (r = 0.96), Test-retest reliability r = (ICC = 0.97).
Modified Barthel Index [6th week]
Use: The MBI was used to measure functional performance in basic activities of daily living (ADL). Inter-rater reliability (ICC ¼ 0.979), Cronbach's coefficient alpha of internal consistency=0.93.
TIME UP AND GO TEST [6th week]
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. Intra-tester and inter-tester reliability (ICC) = 0.92-0.99, Construct validity (Pearson r = -0.79).

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chughtai Rehabilitation Centre	Lahore	Punjab	Pakistan	54000

Sponsors and Collaborators

Riphah International University

Investigators

Principal Investigator: Binash Afzal, PHD*, Riphah international university lahore campus

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Riphah International University

ClinicalTrials.gov Identifier:

NCT05425082

Other Study ID Numbers:

REC/RCR&AHS/22/0225

First Posted:

Jun 21, 2022

Last Update Posted:

Jun 21, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Riphah International University

Stroke

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Jun 21, 2022