Clinical trial NCT06762249: Combined Effect of CIMT and Brunnstrom Therapy on UE in Stroke Patients
Official title: Combined Effect of Constraint Induced Movement Therapy and Brunnstrom Movement Therapy on Upper Extremity Spasticity, Motor Activity and Quality of Life in Stroke Patients
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Stroke Patients
Keywords: Brunnstrom movement therapy
Constraint induced movement therapy
motor activity
quality of life
spacticity
stroke patients
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 56
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Stroke is a leading cause of disability characterized by inadequate blood supply to the brain, leading to cell death and neurological deficits. Motor impairment of the upper extremity is a common consequence among stroke patients, resulting in paralysis of the upper limb. Both Constraint Induced Movement Therapy and Brunnstrom therapy have shown promise in improving motor activity and overall quality of life in stroke patients.This randomized controlled trial will be carried out at in Multan over 10 months. Total number of 56 participants meeting the inclusion criteria will be included in this study. Participants will be randomly assigned into 2 groups . Both groups will receive interventions for five days a week for 4 weeks.

Detailed description: Stroke is the leading cause of death and disability worldwide. Remarkably, approximately 90 percent of strokes have modifiable risk factors, indicating that stroke prevention is largely possible. UE impairments are the common consequence among stroke patients, resulting in a higher likelihood of residual paralysis in the upper limb. These impairments significantly affect the performance of daily activities and diminish patients' quality of life.This study aims to determine the combined effects of constraint induced movement therapy and brunnstrom movement therapy on upper limb spasticity, motor activity and quality of life in stroke patients. This randomized controlled trial will be carried out at in Multan over 10 months after approval of synopsis. Total number of 56 participants meeting the inclusion criteria will be included in this study through a non-probability convenience sampling technique. Participants will be randomly assigned into 2 groups using computer generated method. Group A participants will receive both CIMT and brunnstrom movement therapy with routine physical therapy while Group B participants will receive only CIMT with routine physical therapy. Both groups will receive interventions for five days a week for 4 weeks. The outcome measuring sacales used will be FMUE scale to assess motor activity, FIM scale to assess spasticity and Modified Ashworth scale to assess spasticity. For within group analysis paired t-test will be applied for parametric data. For between group analysis independent t-test will be applied for parametric data. Data analysis will be performed by using SPSS 28 version.

Eligibility criteria: Inclusion Criteria:

* Age group between 40 and 70 years
* Both male and female
* Patient being diagnosed with hemiplegic stroke
* Patient having hemorrhagic stroke or ischemic stroke
* Patient able to give their consent for rehabilitation program
* Patient having 24 or higher score from Standardized Mini-Mental Test
* Patient being able to stand for 2 min without assistance from a person

Exclusion Criteria:

* Patient with cognitive impairment or dementia
* Patient having any other disease that prevents participation in the rehabilitation program
* Patient that participated in any ongoing rehabilitation program
* Patient having pain in UE 4 or higher according to the Visual Analog Scale which is scored 0-10
* Patient had spasticity in any joint of the UE and scored 2 or higher according to the Modified Ashworth Scale

Primary outcomes:
measure: Fugl-Meyer Upper Extremity Motor Evaluation Scale (FM-UE)
timeFrame: 4 weeks
measure: Functional Independence Measure (FIM)
timeFrame: 4 weeks
measure: Modified Ashworth scale
timeFrame: 4 weeks
measure: Mini Mental state examination
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Multan
country: Pakistan
facility: Azeem Electroneurophysiology diognostic and Physiotherapy center Multan
state: Punjab
city: Multan
country: Pakistan
facility: Qaisrani Hospital Multan
state: Punjab
Study officials:
affiliation: Riphah International University
name: Sabiha Arshad
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abba M, Muhammad A, Badaru U, Abdullahi A. Comparative effect of constraintinduced movement therapy and proprioceptive neuromuscular facilitation on upper limb function of chronic stroke survivors. Physiotherapy Quarterly. 2020;28(1):1-5.
citation: . Shaheen S, Afzal B, Tahir M, Mahmood U, Yousaf F, Tariq F. Combined Effects of Brunnstorm Movement Therapy and Low-Level Laser Therapy on Upper Limb Function and Hand Dexterity in Chronic Stroke Patient. Journal of Health and Rehabilitation Research. 2024;4(1):1457-62
citation: Rocha LSO, Gama GCB, Rocha RSB, Rocha LB, Dias CP, Santos LLS, Santos MCS, Montebelo MIL, Teodori RM. Constraint Induced Movement Therapy Increases Functionality and Quality of Life after Stroke. J Stroke Cerebrovasc Dis. 2021 Jun;30(6):105774. doi: 10.1016/j.jstrokecerebrovasdis.2021.105774. Epub 2021 Apr 10.
citation: Terranova TT, Simis M, Santos ACA, Alfieri FM, Imamura M, Fregni F, Battistella LR. Robot-Assisted Therapy and Constraint-Induced Movement Therapy for Motor Recovery in Stroke: Results From a Randomized Clinical Trial. Front Neurorobot. 2021 Jul 21;15:684019. doi: 10.3389/fnbot.2021.684019. eCollection 2021.
citation: Nasb M, Li Z, S A Youssef A, Dayoub L, Chen H. Comparison of the effects of modified constraint-induced movement therapy and intensive conventional therapy with a botulinum-a toxin injection on upper limb motor function recovery in patients with stroke. Libyan J Med. 2019 Dec;14(1):1609304. doi: 10.1080/19932820.2019.1609304.
citation: Puri S, Kovela RK, Qureshi MI, Dadgal R, Timothy R, Samal S. Effect of Brunnstrom Movement Therapy Combined with Neurodevelopmental Therapy on Balance and Mobility in a Patient with Acute Stroke: An Interesting Case Report. JPRI. 2022:6-9.
citation: Dhanalakshmi L, Alagesan J, Buvanesh A. Effectiveness of Constraint Induced Movement Therapy and Proprioceptive Neuromuscular Facilitation on Upper Extremity Functions in Stroke. Indian Journal of Physiotherapy & Occupational Therapy. 2024;18.
citation: Akter R, Sharma N, Ahmed S, Srivastav AK. Combined effect of Brunnstrom's hand rehabilitation and functional electrical stimulation for improving hand function in patients with chronic stroke: A randomized controlled trial. J Bodyw Mov Ther. 2023 Jul;35:84-90. doi: 10.1016/j.jbmt.2023.04.021. Epub 2023 Apr 28.