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

NCT ID: NCT06806553

Last Updated: 2025-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-26

Study Completion Date

2024-12-21

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stroke Hemiparesis Hemiparesis After Stroke Motor Function Upper Limb Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

For a study comparing the effects of Constraint-Induced Movement Therapy (CIMT) combined with Motor Relearning Program (MRP) and Bobath therapy on functional motor recovery in patients with chronic hemiparesis.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Single-blinded assessor was considered to minimize bias in outcome measurements. The assessor was unaware of the intervention group assignment for each participant.

Study Groups

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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.

Group Type EXPERIMENTAL

Constraint-Induced Movement Therapy (CIMT) With Motor Relearning Program (MRP)

Intervention Type BEHAVIORAL

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).

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.

Group Type EXPERIMENTAL

Bobath Therapy

Intervention Type BEHAVIORAL

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).

Interventions

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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).

Intervention Type 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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Lahore

OTHER

Sponsor Role lead

Responsible Party

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Muhammad Ahad

Clinical Demonstrator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Faiza Sharif, PhD.PT

Role: PRINCIPAL_INVESTIGATOR

University of Lahore

Arooj Fatima, Phd.PT

Role: STUDY_DIRECTOR

University of Lahore

Locations

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The University of Lahore Teaching Hospital

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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Lang CE, Strube MJ, Bland MD, Waddell KJ, Cherry-Allen KM, Nudo RJ, Dromerick AW, Birkenmeier RL. Dose response of task-specific upper limb training in people at least 6 months poststroke: A phase II, single-blind, randomized, controlled trial. Ann Neurol. 2016 Sep;80(3):342-54. doi: 10.1002/ana.24734. Epub 2016 Aug 16.

Reference Type BACKGROUND
PMID: 27447365 (View on PubMed)

Jan S, Arsh A, Darain H, Gul S. A randomized control trial comparing the effects of motor relearning programme and mirror therapy for improving upper limb motor functions in stroke patients. J Pak Med Assoc. 2019 Sep;69(9):1242-1245.

Reference Type BACKGROUND
PMID: 31511706 (View on PubMed)

Grozdek Covcic G, Jurak I, Telebuh M, Macek Z, Bertic Z, Zura N, Grubisic M, Matic H, Tislar MH, Jakus L. Effects of Bobath treatment and specific mobilizations on gait in stroke patients: A randomized clinical trial. NeuroRehabilitation. 2022;50(4):493-500. doi: 10.3233/NRE-210326.

Reference Type BACKGROUND
PMID: 35311720 (View on PubMed)

Gracies JM, Pradines M, Ghedira M, Loche CM, Mardale V, Hennegrave C, Gault-Colas C, Audureau E, Hutin E, Baude M, Bayle N; Neurorestore Study Group. Guided Self-rehabilitation Contract vs conventional therapy in chronic stroke-induced hemiparesis: NEURORESTORE, a multicenter randomized controlled trial. BMC Neurol. 2019 Mar 12;19(1):39. doi: 10.1186/s12883-019-1257-y.

Reference Type BACKGROUND
PMID: 30871480 (View on PubMed)

Ghrouz A, Guillen-Sola A, Morgado-Perez A, Munoz-Redondo E, Ramirez-Fuentes C, Curbelo Pena Y, Duarte E. The effect of a motor relearning on balance and postural control in patients after stroke: An open-label randomized controlled trial. Eur Stroke J. 2024 Jun;9(2):303-311. doi: 10.1177/23969873231220218. Epub 2023 Dec 29.

Reference Type BACKGROUND
PMID: 38158722 (View on PubMed)

Other Identifiers

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Rec-UOL-/199/08/24

Identifier Type: -

Identifier Source: org_study_id

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