Isquemic Strokem-CIMTNCT07233161
Effectiveness of m-CIMT of the Upper Limb in Acute Post-stroke Patients. (m-CIMT, Modified Constraint-induced Movement Therapy)
A study testing m-CIMT in people with Isquemic Stroke and Upper Limb Weakness Due to Central Neurologic Injury, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
m-CIMT therapy is the restriction of the unaffected upper extremity in conjunction with an upper extremity specific exercise protocol to improve the functionality and use of the affected upper extremity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Isquemic Stroke, Upper Limb Weakness Due to Central Neurologic Injury
- What is being tested?
- m-CIMT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSpain
- Study dates
- 23 Apr 2025to 20 Dec 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischaemic stroke.
- Hospitalised patient (first 15 days).
- Ability to understand and execute simple instructions.
- Over 18 years of age.
- Upper limb motor deficit.
- Sign the informed consent document.
Who cannot join
- Unstable clinical/medical condition.
- Limitation of the upper limb due to a previous stroke.
- Strokes affecting both upper limbs bilaterally.
- Fractures/dislocations in the joints of the affected upper limb that may affect recovery.
- Severe behavioural disturbance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ines G Garcia, Fisioterapia contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic de Barcelona
Barcelona, Barcelona, 08036
Maria S Suarez, Fisioterapia, +34689409432, suarezi@clinic.cat
About this study
Official title: Effectiveness of m-CIMT of the Upper Limb in Acute Post-stroke Patients.
m-CIMT therapy is the restriction of the unaffected upper extremity in conjunction with an upper extremity specific exercise protocol to improve the functionality and use of the affected upper extremity.
Read the detailed description
The study consists of a total of 7 days with a total of 3 hours per day of restraint of the unaffected upper limb together with 1 physiotherapy session per day specific to the affected upper limb.
- Being tested
- m-CIMT
- Keywords
- m-CIMT, stroke, upper limb weakness, upper limb
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
m-CIMTBehavioural
Also called m-CIMT protocol
m-CIMT therapy (healthy side restraint) and a specific upper limb exercise protocol.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | m-CIMT therapy Receives: Behavioral: m-CIMT |
| Control group | No intervention | Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer
The Fugl-Meyer Upper Extremity Scale assesses motor function of the arm and hand after stroke. It measures movements, reflexes and coordination, with a maximum score of 66. It is a structure-measuring tool. This scale is scored from 0 to 66 with 66 being the best score.
Measured: Basal, immediately after the intervention, 3 months after treatment
Abilhand
The ABILHAND assesses a person's ability to perform manual activities of daily living. It is based on the patient's perception of the difficulty of these tasks. It is a tool for measuring activity. This scale is scored from 0 to 46 with 46 being the best score.
Measured: Basal, immediately after the intervention, 3 months after treatment
Motor Activity Log
The Motor Activity Log (MAL) assesses how much and how well a person uses their affected arm in everyday activities after a stroke. It is based on interviews and rates the Amount of Use and Quality of Movement of the use of the paretic arm in daily life. This scale has two scores, quality and quantity. From 0 to 150 for quantity and from 0 to 150 for quality. 150 being the best result in both cases.
Measured: 3 months after treatment
Fatigue Assessment Scale (FAS)
The Fatigue Assessment Scale (FAS) is a questionnaire that assesses the level of physical and mental fatigue in patients with various health conditions. It consists of 10 items that the patient answers according to their recent experience.
This scale has two scores: Mental fatigue from 0 to 25 (sum of items 3, 6, 7, 8 and 9) and physical fatigue from 0 to 25 (sum of items 1, 2, 4, 5 and 10). With 25 being the worst score for both cases.
Measured: Basal, immediately after the intervention, 3 months after treatment
Stroke Impact Scale
The Stroke Impact Scale (SIS) assesses the difficulty a person has in performing daily activities during the last two weeks after a stroke. The minimum score on this scale is 16 points and the maximum is 80 points, with 80 being the best score.
Measured: Basal,immediately after the intervention, 3 months after treatment
Secondary outcomes (2)
Modified Rankin Scale (MRS)
The modified Rankin Scale (MRS) assesses the degree of disability or dependence in daily activities after a stroke. It ranges from 0 (no symptoms) to 6 (death). The minimum score is 0 and the maximum score is 5 points. The worst score is 5 points.
Measured: Basal, immediately after the intervention, 3 months after treatment
National Institutes of Health Stroke Scale (NIHSS)
The NIHSS (National Institutes of Health Stroke Scale) is a clinical scale that assesses the severity of stroke. It measures functions such as level of consciousness, language, vision, vision, strength, sensation and coordination. This scale is scored from 0 to 42 with 42 being the worst score.
Measured: Basal, immediately after the intervention, 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start23 Apr 2025
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Isquemic StrokeStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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
- Parallel groups
- Model description
- Randomised, single-centre, single-blind, prospective, prospective clinical trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233161
- Sponsor's protocol ID
- HCB/2024/1353
- Acronym
- m-CIMT
- Status last verified
- Apr 2025
- First submitted
- 5 Jun 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We don't have the url with the information
Publications
Kwakkel G, Veerbeek JM, van Wegen EE, Wolf SL. Constraint-induced movement therapy after stroke. Lancet Neurol. 2015 Feb;14(2):224-34. doi: 10.1016/S1474-4422(14)70160-7.
PubMed 25772900Thrane G, Askim T, Stock R, Indredavik B, Gjone R, Erichsen A, Anke A. Efficacy of Constraint-Induced Movement Therapy in Early Stroke Rehabilitation: A Randomized Controlled Multisite Trial. Neurorehabil Neural Repair. 2015 Jul;29(6):517-25. doi: 10.1177/1545968314558599. Epub 2014 Nov 14.
PubMed 25398726Yadav RK, Sharma R, Borah D, Kothari SY. Efficacy of Modified Constraint Induced Movement Therapy in the Treatment of Hemiparetic Upper Limb in Stroke Patients: A Randomized Controlled Trial. J Clin Diagn Res. 2016 Nov;10(11):YC01-YC05. doi: 10.7860/JCDR/2016/23468.8899. Epub 2016 Nov 1.
PubMed 28050492Corbetta D, Sirtori V, Castellini G, Moja L, Gatti R. Constraint-induced movement therapy for upper extremities in people with stroke. Cochrane Database Syst Rev. 2015 Oct 8;2015(10):CD004433. doi: 10.1002/14651858.CD004433.pub3.
PubMed 26446577Singh P, Pradhan B. Study to assess the effectiveness of modified constraint-induced movement therapy in stroke subjects: A randomized controlled trial. Ann Indian Acad Neurol. 2013 Apr;16(2):180-4. doi: 10.4103/0972-2327.112461.
PubMed 23956560
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of m-CIMT of the Upper Limb in Acute Post-stroke Patients.
- ClinicalTrials.gov ID
- NCT07233161
- Acronym / sponsor ID
- m-CIMT / HCB/2024/1353
- Keywords
- m-CIMT, stroke, upper limb weakness, upper limb
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 23 Apr 2025 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 18 Nov 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.
m-CIMT therapy is the restriction of the unaffected upper extremity in conjunction with an upper extremity specific exercise protocol to improve the functionality and use of the affected upper extremity.
Detailed description
The study consists of a total of 7 days with a total of 3 hours per day of restraint of the unaffected upper limb together with 1 physiotherapy session per day specific to the affected upper limb.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised, single-centre, single-blind, prospective, prospective clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: m-CIMTm-CIMT therapy |
| Control group | No intervention | –Conventional treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ischaemic stroke.
- Hospitalised patient (first 15 days).
- Ability to understand and execute simple instructions.
- Over 18 years of age.
- Upper limb motor deficit.
Key exclusion criteria (5 listed)
- Unstable clinical/medical condition.
- Limitation of the upper limb due to a previous stroke.
- Strokes affecting both upper limbs bilaterally.
- Fractures/dislocations in the joints of the affected upper limb that may affect recovery.
- Severe behavioural disturbance.
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 |
|---|---|---|
| m-CIMTAlso: m-CIMT protocolm-CIMT therapy (healthy side restraint) and a specific upper limb exercise protocol. | Behavioural | Experimental |
Primary outcome
Fugl-Meyer
Time frame: Basal, immediately after the intervention, 3 months after treatment
The Fugl-Meyer Upper Extremity Scale assesses motor function of the arm and hand after stroke. It measures movements, reflexes and coordination, with a maximum score of 66. It is a structure-measuring tool. This scale is scored from 0 to 66 with 66 being the best score.
Abilhand
Time frame: Basal, immediately after the intervention, 3 months after treatment
The ABILHAND assesses a person's ability to perform manual activities of daily living. It is based on the patient's perception of the difficulty of these tasks. It is a tool for measuring activity. This scale is scored from 0 to 46 with 46 being the best score.
Motor Activity Log
Time frame: 3 months after treatment
The Motor Activity Log (MAL) assesses how much and how well a person uses their affected arm in everyday activities after a stroke. It is based on interviews and rates the Amount of Use and Quality of Movement of the use of the paretic arm in daily life. This scale has two scores, quality and quantity. From 0 to 150 for quantity and from 0 to 150 for quality. 150 being the best result in both cases.
Fatigue Assessment Scale (FAS)
Time frame: Basal, immediately after the intervention, 3 months after treatment
The Fatigue Assessment Scale (FAS) is a questionnaire that assesses the level of physical and mental fatigue in patients with various health conditions. It consists of 10 items that the patient answers according to their recent experience. This scale has two scores: Mental fatigue from 0 to 25 (sum of items 3, 6, 7, 8 and 9) and physical fatigue from 0 to 25 (sum of items 1, 2, 4, 5 and 10). With 25 being the worst score for both cases.
Stroke Impact Scale
Time frame: Basal,immediately after the intervention, 3 months after treatment
The Stroke Impact Scale (SIS) assesses the difficulty a person has in performing daily activities during the last two weeks after a stroke. The minimum score on this scale is 16 points and the maximum is 80 points, with 80 being the best score.
2 secondary outcomes
Modified Rankin Scale (MRS)
Time frame: Basal, immediately after the intervention, 3 months after treatment
National Institutes of Health Stroke Scale (NIHSS)
Time frame: Basal, immediately after the intervention, 3 months after treatment
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 18 Nov 2025.
- Background: PubMed 25772900Kwakkel G, Veerbeek JM, van Wegen EE, Wolf SL. Constraint-induced movement therapy after stroke. Lancet Neurol. 2015 Feb;14(2):224-34. doi: 10.1016/S1474-4422(14)70160-7.
- Background: PubMed 25398726Thrane G, Askim T, Stock R, Indredavik B, Gjone R, Erichsen A, Anke A. Efficacy of Constraint-Induced Movement Therapy in Early Stroke Rehabilitation: A Randomized Controlled Multisite Trial. Neurorehabil Neural Repair. 2015 Jul;29(6):517-25. doi: 10.1177/1545968314558599. Epub 2014 Nov 14.
- Background: PubMed 28050492Yadav RK, Sharma R, Borah D, Kothari SY. Efficacy of Modified Constraint Induced Movement Therapy in the Treatment of Hemiparetic Upper Limb in Stroke Patients: A Randomized Controlled Trial. J Clin Diagn Res. 2016 Nov;10(11):YC01-YC05. doi: 10.7860/JCDR/2016/23468.8899. Epub 2016 Nov 1.
- Background: PubMed 26446577Corbetta D, Sirtori V, Castellini G, Moja L, Gatti R. Constraint-induced movement therapy for upper extremities in people with stroke. Cochrane Database Syst Rev. 2015 Oct 8;2015(10):CD004433. doi: 10.1002/14651858.CD004433.pub3.
- Background: PubMed 23956560Singh P, Pradhan B. Study to assess the effectiveness of modified constraint-induced movement therapy in stroke subjects: A randomized controlled trial. Ann Indian Acad Neurol. 2013 Apr;16(2):180-4. doi: 10.4103/0972-2327.112461.
- Individual participant dataSharing planned: Undecided. We don't have the url with the information
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.
Ines G Garcia, Fisioterapia contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing m-CIMT in people with Isquemic Stroke and Upper Limb Weakness Due to Central Neurologic Injury, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 6 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: looking for participants now, as of the sponsor's last update on 18 Nov 2025. 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 Spain. 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?
Contact Maria S Suarez, Fisioterapia (+34689409432, suarezi@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer (time frame: Basal, immediately after the intervention, 3 months after treatment). The study lists 5 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 NCT07233161, which also lists 5 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 18 Nov 2025.