Chronic StrokeNCT06548295
Effects of mCIMT vs CT on Upper Extremity Motor Function and ADLs in Chronic Stroke Patients
A study testing modified constraint induced movement therapy (mCIMT) and conservative treatment in people with Chronic Stroke, run by Superior University at 1 site in Pakistan.
Trial summary
"Cerebral palsy (CP) affects gross motor function variably, with the spastic type notably impacting movement, coordination, and balance. Research highlights that spastic CP, characterized by muscle stiffness, can severely hinder activities like walking and running. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- modified constraint induced movement therapy (mCIMT) and conservative treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Participants will be under the age of 40-75 years
- Diagnosis: stroke
Who cannot join
- patients suffering from motor dysfunction due to other diseases (e.g., cerebral palsy, traumatic brain injury, and Parkinson's disease
- Balance problem
- Rheumatic diseases
- High spasticity
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Little angles home aziz bhati shaheed road opposit junior aps
Sialkot
About this study
Official title: Effects of Modified Constraint Induced Movement Therapy (mCIMT) Versus Conservative Treatment on Upper Extremity Motor Function and ADLs in Chronic Stroke Patients
"Cerebral palsy (CP) affects gross motor function variably, with the spastic type notably impacting movement, coordination, and balance. Research highlights that spastic CP, characterized by muscle stiffness, can severely hinder activities like walking and running.
Read the detailed description
Interventions such as gait training and vibrational therapy have shown promise in enhancing muscle function and body movements. A new device, EKKO, uses vibrational waves based on Neurotransmission Cognitive Theory to improve gross motor skills in children with CP by applying mechanical vibrations to nerve points. This study aims to compare the efficacy of EKKO therapy with traditional conservative treatments (such as range of motion exercises and balance training) in improving gross motor function in children with CP. Conducted over six months with randomized controlled trials, the research seeks to provide evidence-based insights into optimizing rehabilitation strategies for better motor performance and quality of life for CP patients.
- Conditions
- Chronic Stroke
- Being tested
- modified constraint induced movement therapy (mCIMT), conservative treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified constraint induced movement therapy (mCIMT)Behavioural
Restraint the involved extremity by using a mitten. Repetitive task practice i.e filling a glass, drinking a glass of water, and eating with a spoon , stacking cones and stacking blocks, grasping and releasing of an object, reaching forward and sideways, lifting and dropping of an object from the one end of table to the other end.
The shaping exercises included cube stacking, card turning, throwing balls into a box, grasping/holding and placing objects of different sizes, and drawing and painting exercises. Intervention: 5 sessions per week for 50 minutes for 6 weeks
conservative treatmentCombination product
The conservative rehabilitation program consisted of upper-limb range of motion exercises, positioning, stretching, and strengthening exercises, Passive mobilization of the shoulder ,elbow , wrist and small joints of hand Stretching of the affected arm including biceps, triceps and muscles of forearm and hand.
Strengthening exercises of upper arm and forearm muscles involved. Intervention: 5 sessions per week for six weeks and 50 mintues
| Study group | Role | What they receive |
|---|---|---|
| modified constraint induced movement therapy (mCIMT) | Experimental | Not described Receives: Behavioral: modified constraint induced movement therapy (mCIMT) |
| conservative treatment | Experimental | Not described Receives: Combination Product: conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barthal index
Barthel Index (BI) stands out as a widely utilized measure for assessing basic activities of daily living (ADL). Scores of 0-20 indicate "total" dependency. Scores of 21-60 indicate "severe" dependency. Scores of 61-90 indicate "moderate" dependency.
Measured: 12 Months
The use of FMA-UE
measureing comprising 30 items for motor function and 3 items for reflex function, provides a comprehensive evaluation of motor abilities .
In regards to UE feature, 33 elements evaluate motor function, six items assess sensitivity and proprioception, while the last 24 points rate joint pain and mobility.
Every item of the assessment scale is marked on an ordinal level, from 0 to 2; the 0 value corresponds with the impossibility to perform a movement, and 2 represents the ability to perform a complete and adequate movement
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start1 Oct 2023
- Primary completion1 May 2024
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548295
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/733
- Status last verified
- Aug 2024
- First submitted
- 7 Aug 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Modified Constraint Induced Movement Therapy (mCIMT) Versus Conservative Treatment on Upper Extremity Motor Function and ADLs in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT06548295
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/733
- Conditions
- Chronic Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 12 Aug 2024 (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.
"Cerebral palsy (CP) affects gross motor function variably, with the spastic type notably impacting movement, coordination, and balance. Research highlights that spastic CP, characterized by muscle stiffness, can severely hinder activities like walking and running.
Detailed description
Interventions such as gait training and vibrational therapy have shown promise in enhancing muscle function and body movements. A new device, EKKO, uses vibrational waves based on Neurotransmission Cognitive Theory to improve gross motor skills in children with CP by applying mechanical vibrations to nerve points. This study aims to compare the efficacy of EKKO therapy with traditional conservative treatments (such as range of motion exercises and balance training) in improving gross motor function in children with CP. Conducted over six months with randomized controlled trials, the research seeks to provide evidence-based insights into optimizing rehabilitation strategies for better motor performance and quality of life for CP patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| modified constraint induced movement therapy (mCIMT) | Experimental | Behavioral: modified constraint induced movement therapy (mCIMT) |
| conservative treatment | Experimental | Combination Product: conservative treatment |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants will be under the age of 40-75 years
- Diagnosis: stroke
Key exclusion criteria (4 listed)
- patients suffering from motor dysfunction due to other diseases (e.g., cerebral palsy, traumatic brain injury, and Parkinson's disease
- Balance problem
- Rheumatic diseases
- High spasticity
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 |
|---|---|---|
| modified constraint induced movement therapy (mCIMT)Restraint the involved extremity by using a mitten. Repetitive task practice i.e filling a glass, drinking a glass of water, and eating with a spoon , stacking cones and stacking blocks, grasping and releasing of an object, reaching forward and sideways, lifting and dropping of an object from the one end of table to the other end. The shaping exercises included cube stacking, card turning, throwing balls into a box, grasping/holding and placing objects of different sizes, and drawing and painting exercises. Intervention: 5 sessions per week for 50 minutes for 6 weeks | Behavioural | modified constraint induced movement therapy (mCIMT) |
| conservative treatmentThe conservative rehabilitation program consisted of upper-limb range of motion exercises, positioning, stretching, and strengthening exercises, Passive mobilization of the shoulder ,elbow , wrist and small joints of hand Stretching of the affected arm including biceps, triceps and muscles of forearm and hand. Strengthening exercises of upper arm and forearm muscles involved. Intervention: 5 sessions per week for six weeks and 50 mintues | Combination product | conservative treatment |
Primary outcome
Barthal index
Time frame: 12 Months
Barthel Index (BI) stands out as a widely utilized measure for assessing basic activities of daily living (ADL). Scores of 0-20 indicate "total" dependency. Scores of 21-60 indicate "severe" dependency. Scores of 61-90 indicate "moderate" dependency.
The use of FMA-UE
Time frame: 12 months
measureing comprising 30 items for motor function and 3 items for reflex function, provides a comprehensive evaluation of motor abilities . In regards to UE feature, 33 elements evaluate motor function, six items assess sensitivity and proprioception, while the last 24 points rate joint pain and mobility. Every item of the assessment scale is marked on an ordinal level, from 0 to 2; the 0 value corresponds with the impossibility to perform a movement, and 2 represents the ability to perform a complete and adequate movement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing modified constraint induced movement therapy (mCIMT) and conservative treatment in people with Chronic Stroke, run by Superior University at 1 site 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Barthal index (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2024.