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

NCT06806553 | Completed DMC

• 1 other identifier: Rec-UOL-/199/08/24
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke; Hemiparesis; Hemiparesis After Stroke; Motor Function; Upper Limb Function

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (1)

• Pain

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

Study Arms (2)

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

EXPERIMENTAL

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)

Bobath therapy

EXPERIMENTAL

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

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

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

Bobath Therapy 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).

Bobath therapy

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

The University of Lahore Teaching Hospital

Lahore, Punjab Province, 54590, Pakistan

Location

Related Publications (5)

• 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.

  PMID: 27447365 BACKGROUND

• 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.

  PMID: 31511706 BACKGROUND

• 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.

  PMID: 35311720 BACKGROUND

• 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.

  PMID: 30871480 BACKGROUND

• 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.

  PMID: 38158722 BACKGROUND

MeSH Terms

Conditions

Stroke; Paresis

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Faiza Sharif, PhD.PT

  University of Lahore

  PRINCIPAL INVESTIGATOR

• Arooj Fatima, Phd.PT

  University of Lahore

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-blinded assessor was considered to minimize bias in outcome measurements. The assessor was unaware of the intervention group assignment for each participant.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Demonstrator

Model Details: 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.

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 4, 2025
• Study Start: January 26, 2024
• Primary Completion: November 11, 2024
• Study Completion: December 21, 2024
• Last Updated: February 4, 2025

Record last verified: 2025-01

Locations

PA (1)