Clinical trial NCT06806553: Constraint-Induced Movement Therapy (CIMT) with Motor Relearning Program (MRP) and Bobath Approach to Augment Functional Motor Recovery of Chronic Hemiparetic Arm
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2025-02-04
Enrollment: 64
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Fugl-Meyer Assessment (FMA)
timeFrame: Baseline, mid-intervention (3 weeks), and post-intervention (6 weeks).
measure: Modified Ashworth Scale (MAS)
timeFrame: Baseline, mid-intervention (3 weeks), and post-intervention (6 weeks).
Secondary outcomes:
measure: Pain
timeFrame: Baseline, mid-intervention (3 weeks), and post-intervention (6 weeks).
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: The University of Lahore Teaching Hospital
state: Punjab
Study officials:
affiliation: University of Lahore
name: Faiza Sharif, PhD.PT
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Lahore
name: Arooj Fatima, Phd.PT
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.