Constraint-Induced Movement Therapy (CIMT) with Motor Relearning Program (MRP) and Bobath Approach to Augment Functional Motor Recovery of Chronic Hemiparetic Arm (CIMT-MRP)

January 28, 2025 updated by: Muhammad Ahad, University of Lahore

Comparative Effects of Constraint-Induced Movement Therapy (CIMT) with Motor Relearning Program (MRP) and Bobath Approach to Augment Functional Motor Recovery of Chronic Hemiparetic Arm

Hemiparesis is a condition characterized by weakness or the inability to move on one side of the body, making it difficult to perform everyday activities like eating or dressing (Iswatun et al., 2022). It is a common after-effect of stroke that causes weakness on one side of the body, limiting movement and affecting all basic activities such as dressing, eating, and walking. Hemiparesis can also be a sign of a stroke, and the side of the body weakened by hemiparesis could be ipsilateral (the same side as the brain injury) or contralateral (the opposite side of the brain injury) (Obman, 2020).

The symptoms of hemiparesis include: Weakness, Difficulty walking, Loss of balance, Muscle fatigue, Difficulty with coordination, Inability to grasp objects. Additionally, a person with hemiparesis may experience trouble maintaining balance, standing, or walking, as well as a tingling or numbing sensation on the weak side (Brandstaedter & Lindenbaum, 2023). Difficulty grabbing things, moving with precision, and lack of coordination can also be present. Hemiparesis is a one-sided muscle weakness that can affect all or most of the anatomical segments on one side of the body (Dantes et al., 2020).

Constraint-Induced Movement Therapy (MCIMT) with combination of Motor Relearning Program (MRP) has significant effects on stroke rehabilitation. CIMT is considered to achieve its beneficial effects through mechanisms such as overcoming learned nonuse and use-dependent neural plasticity. However, in case of Bobath there in no such evidence. Therefore more studies are needed to evaluate the effects of CIMT with MRP and Bobath only in both acute and chronic post-stroke populations. Therefore, the aim of this research is to focus on rehabilitation of hemiparetic arm. This present study compared the effects of CIMT with MRP versus Bobath to Augment Functional Motor Recovery of Chronic Hemiparetic Arm.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To determine the comparative effects of constraint-induced movement therapy (CIMT) with motor relearning program (MRP) and Bobath therapy to augment functional motor recovery of chronic hemiparetic arm.

Study Design: Randomized Control Trial

Study Setting: The data was collected from the University of Lahore Teaching Hospital and Sehat Medical Complex , Lahore.

Study Duration: 9 months after the approval of synopsis.

Sampling technique: It was purposive sampling technique.

Sample size: The sample size was 56 (28 in each group ) in each group calculated through software

Group A (CIMT +MRP)

Group B (Bobath)

Screening: Patients were screened to meet inclusion criteria. The consent form was taken from patients then patients will be randomly allocated into two groups ( 28 in each group).

Randomization: Patients fulfilling the inclusion criteria were randomly divided into experimental and control groups using the computer software.

Blinding: The study was single-blinded. The assessor was unaware of the treatment given to both groups.

Assessment: Data was collected at baseline, third and then at the end of the six week. Baseline assessments was conducted before the intervention. Post-intervention assessments were conducted immediately after the intervention. Statistical analysis included descriptive statistics, normality test and analysis of variance to compare the outcomes between the two groups.

Treatment Plan:

Both CIMT with MRP and Bobath both groups received 6 weeks of therapy, 5 days per week, for 3 hours/day per session. Each session was divided into phases: warm-up, active intervention, cool-down.Therapists monitored participant progress and adjust difficulty levels as needed. Home exercise programs was provided for daily practice.

Ethical Considerations: This study has received ethical approval from the Institutional Review Board (IRB). Informed consent was obtained from all participants.

Data Analysis: Statistical software was used to analyze the data, with appropriate tests employed based on data normality to compare outcomes between groups.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54590
        • The University of Lahore Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed with chronic hemiparesis at least 6 months prior to study enrollment (Lang et al., 2016).
  • Chronic hemiparesis affecting one arm only (Lang et al., 2016).
  • Age between 50 and 65 years old (Lang et al., 2016).
  • Patients experiencing functional limitations in upper limb motor function (Gracies et al., 2019).
  • Mini-Mental State Examination (MMSE) score ≥ 24 (Page et al., 2007).
  • Patients with mild to moderate spasticity (Jan et al., 2019).
  • Able to tolerate and participate actively in the assigned intervention (Gracies et al., 2019)

Exclusion Criteria:

  • Recent acute medical/surgical condition unrelated to stroke (Lang et al., 2016).
  • Severe cognitive impairment or communication difficulties (Lang et al., 2016)
  • Uncontrolled pain or spasticity in the affected arm (Lang et al., 2016).
  • History of shoulder instability or major orthopedic surgery in the affected arm (Gracies et al., 2019).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Constraint-Induced Movement Therapy (CIMT) with the Motor Relearning Program (MRP)
Intensive training sessions focusing on the paretic arm. The unaffected arm is constrained using a mitt or sling to encourage using the affected limb. Emphasis on repetitive practice of functional tasks to enhance motor learning and skill acquisition. MRP Components: Standard physiotherapy sessions emphasizing strength, range of motion, and coordination. Task-specific training and neuromuscular re-education to improve motor function. Therapy sessions are conducted five days a week for six weeks, with additional home exercise programs to reinforce skills.
Behavioral: Constraint-Induced Movement Therapy (CIMT) With Motor Relearning Program (MRP)

Intensive training sessions of 3 hours/day for 6 weeks, focusing on functional tasks with the paretic arm while constraining the unaffected arm using a mitt or sling. Implement a constraint on the non-paretic arm to encourage increased use of the affected arm in daily activities. Use shaping techniques to gradually increase the complexity and difficulty of tasks performed with the affected arm (Rahman, 2016).

MRP: Standard physiotherapy sessions of 1 hour/day for 6 weeks, including exercises for both affected and unaffected arm. Focus on improving strength, range of motion, and coordination through repetitive task practice, neuromuscular re-education and compensatory strategies (Brkić, 2016; Ghrouz et al., 2023).
Experimental: Bobath therapy
Bobath therapy is a task-oriented approach focusing on balance, postural control, and the facilitation of normal movement patterns to improve motor skills and independence. It aims to inhibit abnormal muscle tone and promote efficient motor strategies.
Behavioral: Bobath Therapy
The first step in the Bobath approach is a thorough assessment of the individual's movement patterns, muscle tone, strength, coordination, and functional abilities. This assessment helps in identifying specific impairments and setting goals for treatment. Bobath therapists use specific handling techniques to facilitate normal movement patterns and inhibit abnormal muscle tone. These hands-on techniques aim to promote efficient movement and improve motor control. The Bobath approach emphasizes task-oriented training, where functional activities relevant to the individual's daily life are incorporated into therapy sessions. This helps in improving motor skills in a context that is meaningful to the individual (Grozdek Čovčić et al., 2022; Kuciel et al., 2021).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment (FMA)
Time Frame: Baseline, mid-intervention (3 weeks), and post-intervention (6 weeks).
The Fugl-Meyer Assessment (FMA) is a widely used clinical tool designed to evaluate motor impairment, balance, sensation, and joint functioning in individuals with post-stroke hemiplegia. It consists of various items that assess motor function in the upper and lower extremities, providing a comprehensive measure of motor recovery post-stroke.
Baseline, mid-intervention (3 weeks), and post-intervention (6 weeks).
Modified Ashworth Scale (MAS)
Time Frame: Baseline, mid-intervention (3 weeks), and post-intervention (6 weeks).
The Modified Ashworth Scale (MAS) is a 6-point scale used to assess spasticity in patients with lesions to the central nervous system. Scores on the MAS range from 0 to 4, where lower scores represent normal muscle tone and higher scores indicate increased spasticity. The MAS assigns a grade of spasticity based on resistance encountered during passive movement, with a grade of 0 indicating no increase in muscle tone and a grade of 4 representing limb rigidity in flexion or extension.
Baseline, mid-intervention (3 weeks), and post-intervention (6 weeks).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: Baseline, mid-intervention (3 weeks), and post-intervention (6 weeks).
The Numeric Pain Rating Scale is a widely utilized tool for assessing pain intensity in adults. It operates on an 11-point scale ranging from 0 to 10, where 0 indicates no pain and 10 represents the worst pain imaginable. Higher scores on this scale signify greater pain intensity, making it a straightforward method for patients to communicate their pain levels to healthcare providers.
Baseline, mid-intervention (3 weeks), and post-intervention (6 weeks).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lahore

Investigators

  • Principal Investigator: Faiza Sharif, PhD.PT, University of Lahore
  • Study Director: Arooj Fatima, Phd.PT, University of Lahore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2024

Primary Completion (Actual)

November 11, 2024

Study Completion (Actual)

December 21, 2024

Study Registration Dates

First Submitted

January 28, 2025

First Submitted That Met QC Criteria

January 28, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 28, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rec-UOL-/199/08/24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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