Stroke PatientsNCT06762249
Combined Effect of CIMT and Brunnstrom Therapy on UE in Stroke Patients
A study testing CIMT + Brunnstrom therapy + routine physical therapy and CIMT + routine physical therapy in people with Stroke Patients, run by Riphah International University at 2 sites in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Stroke Patients
- What is being tested?
- CIMT + Brunnstrom therapy + routine physical therapy and CIMT + routine physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Oct 2024to 1 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan2 sites
Azeem Electroneurophysiology diognostic and Physiotherapy center Multan
Multan, Punjab Province
Qaisrani Hospital Multan
Multan, Punjab Province
About this study
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
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.
Read the 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.
- Conditions
- Stroke Patients
- Being tested
- CIMT + Brunnstrom therapy + routine physical therapy, CIMT + routine physical therapy
- Keywords
- Brunnstrom movement therapy, Constraint induced movement therapy, motor activity, quality of life, spacticity, stroke patients
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CIMT + Brunnstrom therapy + routine physical therapyOther
this therapy will be given for 5 days per week for 4 weeks.
CIMT + routine physical therapyOther
this therapy will be given for 5 days per week for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| CIMT+ Brunnstrom therapy + routine physical therapy. | Experimental | Group A participants will receive Constraints innduced movement therapy and Brunnstrom movement therapy along with routine physical therapy This therapy will be given as 5 days session for 4 weeks. Receives: Other: CIMT + Brunnstrom therapy + routine physical therapy |
| CIMT + routine physical therapy | Active comparator | Group B participants will receive Constraint Induced movement therapy along with routine physical therapy exercises. This therapy will be given for 4 weeks. Receives: Other: CIMT + routine physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Upper Extremity Motor Evaluation Scale (FM-UE)
The FMA-UE consists of 30 items assessing motor function and 3 items assessing reflex function. The score most applicable to task performance is given from "0, inability," "1, beginning ability," to "2, normal"
Measured: 4 weeks
Functional Independence Measure (FIM)
The scale consists of six sub-headings and a total of 18 items. Scores that can be obtained from the scale range from 18-126, and higher scores indicate that the individual is more independent in daily life
Measured: 4 weeks
Modified Ashworth scale
The modified Ashworth scale is a muscle tone assessment scale used to assess the resistance experienced during passive range of motion, which does not require any instrumentation and is quick to perform.
Measured: 4 weeks
Mini Mental state examination
The MMSE is a widely used cognition screening test. It has a maximum score of 30 points. It assesses aspects of orientation, recall, language and visual construction.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start1 Oct 2024
- Primary completion1 Feb 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Stroke PatientsStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabiha Arshad, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762249
- Sponsor's protocol ID
- REC/RCR & AHS/24/0250
- Status last verified
- Jan 2025
- First submitted
- 1 Jan 2025
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
. 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
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.
PubMed 33848906Terranova 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.
PubMed 34366819Nasb 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.
PubMed 31032717Puri 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.
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.
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.
PubMed 37330808
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06762249
- Acronym / sponsor ID
- REC/RCR & AHS/24/0250
- Conditions
- Stroke Patients
- Keywords
- Brunnstrom movement therapy, Constraint induced movement therapy, motor activity, quality of life, spacticity, stroke patients
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CIMT+ Brunnstrom therapy + routine physical therapy. | Experimental | Other: CIMT + Brunnstrom therapy + routine physical therapyGroup A participants will receive Constraints innduced movement therapy and Brunnstrom movement therapy along with routine physical therapy This therapy will be given as 5 days session for 4 weeks. |
| CIMT + routine physical therapy | Active comparator | Other: CIMT + routine physical therapyGroup B participants will receive Constraint Induced movement therapy along with routine physical therapy exercises. This therapy will be given for 4 weeks. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CIMT + Brunnstrom therapy + routine physical therapythis therapy will be given for 5 days per week for 4 weeks. | Other | CIMT+ Brunnstrom therapy + routine physical therapy. |
| CIMT + routine physical therapythis therapy will be given for 5 days per week for 4 weeks | Other | CIMT + routine physical therapy |
Primary outcome
Fugl-Meyer Upper Extremity Motor Evaluation Scale (FM-UE)
Time frame: 4 weeks
The FMA-UE consists of 30 items assessing motor function and 3 items assessing reflex function. The score most applicable to task performance is given from "0, inability," "1, beginning ability," to "2, normal"
Functional Independence Measure (FIM)
Time frame: 4 weeks
The scale consists of six sub-headings and a total of 18 items. Scores that can be obtained from the scale range from 18-126, and higher scores indicate that the individual is more independent in daily life
Modified Ashworth scale
Time frame: 4 weeks
The modified Ashworth scale is a muscle tone assessment scale used to assess the resistance experienced during passive range of motion, which does not require any instrumentation and is quick to perform.
Mini Mental state examination
Time frame: 4 weeks
The MMSE is a widely used cognition screening test. It has a maximum score of 30 points. It assesses aspects of orientation, recall, language and visual construction.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- BackgroundAbba 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.
- Background. 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
- Background: PubMed 33848906Rocha 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.
- Background: PubMed 34366819Terranova 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.
- Background: PubMed 31032717Nasb 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.
- BackgroundPuri 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.
- BackgroundDhanalakshmi 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.
- Background: PubMed 37330808Akter 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sabiha Arshad principal investigator
Riphah International University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CIMT + Brunnstrom therapy + routine physical therapy and CIMT + routine physical therapy in people with Stroke Patients, run by Riphah International University at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Upper Extremity Motor Evaluation Scale (FM-UE) (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06762249, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.