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

NCT07233161 | Recruiting

• 1 other identifier: HCB/2024/1353
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Isquemic Stroke; Upper Limb Weakness Due to Central Neurologic Injury

Keywords

m-CIMT; stroke; upper limb weakness; upper limb

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  Basal,immediately after the intervention, 3 months after treatment

Secondary Outcomes (2)

• Modified Rankin Scale (MRS)

  Basal, immediately after the intervention, 3 months after treatment

• National Institutes of Health Stroke Scale (NIHSS)

  Basal, immediately after the intervention, 3 months after treatment

Study Arms (2)

Experimental

EXPERIMENTAL

m-CIMT therapy

Behavioral: m-CIMT

Control group

NO INTERVENTION

Conventional treatment

Interventions

m-CIMT BEHAVIORAL

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

Also known as: m-CIMT protocol

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, Barcelona, 08036, Spain

RECRUITING

Related Publications (5)

• 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.

  PMID: 25772900 BACKGROUND

• 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.

  PMID: 25398726 BACKGROUND

• 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.

  PMID: 28050492 BACKGROUND

• 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.

  PMID: 26446577 BACKGROUND

• 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.

  PMID: 23956560 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Maria S Suarez, Fisioterapia

CONTACT

+34689409432; suarezi@clinic.cat

Ines G Garcia, Fisioterapia

CONTACT

+34665538737

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised, single-centre, single-blind, prospective, prospective clinical trial.

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: November 18, 2025
• Study Start: April 23, 2025
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-04

Locations

ES (1)