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Comparison of Motor Relearning and Neurodevelopmental Therapy in Stroke Patients

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Motor relearning program
Neurodevelopmental therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Chughtai Rehabilitation CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Motor relearning program

Neurodevelopmental therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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. Criterion Validity: total score correlations (r = 0.96), Test-retest reliability r = (ICC = 0.97).
Modified Barthel Index
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
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).

Secondary Outcome Measures

Full Information

First Posted
June 15, 2022
Last Updated
June 15, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05425082
Brief Title
Comparison of Motor Relearning and Neurodevelopmental Therapy in Stroke Patients
Official Title
Comparison of Motor Relearning and Neurodevelopmental Therapy on Motor Performance and Quality of Life in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 4, 2022 (Actual)
Primary Completion Date
September 15, 2022 (Anticipated)
Study Completion Date
November 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Motor relearning program
Arm Type
Active Comparator
Arm Description
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
Arm Title
Neurodevelopmental therapy
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Motor relearning program
Intervention Description
Treatment session of one hour per day for five days a week, for four weeks for each participant until 20 sessions
Intervention Type
Other
Intervention Name(s)
Neurodevelopmental therapy
Intervention Description
Treatment session of one hour per day for five days a week, for four weeks for each participant until 20 sessions.
Primary Outcome Measure Information:
Title
Fugl Meyer Assessment Scale
Description
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).
Time Frame
6th week
Title
Modified Barthel Index
Description
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 Frame
6th week
Title
TIME UP AND GO TEST
Description
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).
Time Frame
6th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
imran Amjad, phD
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Binash Afzal, PHD*
Organizational Affiliation
Riphah international university lahore campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chughtai Rehabilitation Centre
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ambreen Aslam, Ms NMPT

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Comparison of Motor Relearning and Neurodevelopmental Therapy in Stroke Patients

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