Effectiveness of m-CIMT of the Upper Limb in Acute Post-stroke Patients. (m-CIMT, Modified Constraint-induced Movement Therapy)

NCT ID: NCT07233161

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-23

Study Completion Date

2026-12-20

Brief Summary

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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

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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.

Conditions

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Isquemic Stroke Upper Limb Weakness Due to Central Neurologic Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised, single-centre, single-blind, prospective, prospective clinical trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Experimental

m-CIMT therapy

Group Type EXPERIMENTAL

m-CIMT

Intervention Type BEHAVIORAL

m-CIMT therapy (healthy side restraint) and a specific upper limb exercise protocol.

Control group

Conventional treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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m-CIMT

m-CIMT therapy (healthy side restraint) and a specific upper limb exercise protocol.

Intervention Type BEHAVIORAL

Other Intervention Names

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m-CIMT protocol

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Clinic de Barcelona

Barcelona, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Maria S Suarez, Fisioterapia

Role: CONTACT

+34689409432

Ines G Garcia, Fisioterapia

Role: CONTACT

+34665538737

Facility Contacts

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Maria S Suarez, Fisioterapia

Role: primary

+34689409432

References

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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.

Reference Type BACKGROUND
PMID: 25772900 (View on PubMed)

Thrane 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.

Reference Type BACKGROUND
PMID: 25398726 (View on PubMed)

Yadav 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.

Reference Type BACKGROUND
PMID: 28050492 (View on PubMed)

Corbetta 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.

Reference Type BACKGROUND
PMID: 26446577 (View on PubMed)

Singh 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.

Reference Type BACKGROUND
PMID: 23956560 (View on PubMed)

Other Identifiers

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HCB/2024/1353

Identifier Type: -

Identifier Source: org_study_id

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