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CompletedNCT06806553CIMT-MRPUpdated Feb 4, 2025

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

An interventional study of Constraint-Induced Movement Therapy (CIMT) With Motor Relearning Program (MRP) and Bobath Therapy in Stroke, Hemiparesis and Hemiparesis After Stroke, sponsored by University of Lahore. Completed at 1 site in Pakistan. Open to participants aged 50 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-02-04.

Sponsored by University of Lahore · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Jan 2024, registered Jan 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
50 Years to 65 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Stroke
  • Hemiparesis
  • Hemiparesis After Stroke
  • Motor Function
  • Upper Limb Function

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Keywords

  • Constraint-Induced Movement Therapy (CIMT)
  • Motor Relearning Program (MRP)
  • Bobath Therapy
  • Stroke Rehabilitation
  • Upper Limb Hemiparesis
  • Motor Function Recovery
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 64 is above the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

University of Lahore is the lead sponsor of 223 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
64 participants (actual)

Study arms

  • 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)

  • 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

Interventions

  • BehavioralConstraint-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).

  • BehavioralBobath 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).

06

What researchers measure

Primary outcomes

  1. Fugl-Meyer Assessment (FMA)

    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.

    Time frame: Baseline, mid-intervention (3 weeks), and post-intervention (6 weeks).

  2. Modified Ashworth Scale (MAS)

    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.

    Time frame: Baseline, mid-intervention (3 weeks), and post-intervention (6 weeks).

Secondary outcomes

  1. Pain

    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.

    Time frame: Baseline, mid-intervention (3 weeks), and post-intervention (6 weeks).

07

Study locations

1 site
  • The University of Lahore Teaching Hospital
    Lahore, Punjab 54590, Pakistan
08

References and documents

Publications

  • 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. PubMed 27447365 ↗
  • 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. PubMed 31511706 ↗
  • 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. PubMed 35311720 ↗
  • 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. PubMed 30871480 ↗
  • 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. PubMed 38158722 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06806553
Lead sponsor
University of Lahore
Responsible party
Muhammad Ahad (Clinical Demonstrator, University of Lahore Teaching Hospital) — Principal investigator
First posted
Feb 4, 2025
Start date
Jan 26, 2024
Primary completion
Nov 11, 2024
Completion
Dec 21, 2024
Last update
Feb 4, 2025

Study contacts

Faiza Sharif, PhD.PT
principal investigator · University of Lahore
Arooj Fatima, Phd.PT
study director · University of Lahore

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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