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

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.

Study Overview

• Status: Recruiting
• Conditions: Upper Limb Weakness Due to Central Neurologic Injury; Isquemic Stroke
• Intervention / Treatment: Behavioral: m-CIMT

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 Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria S Suarez, Fisioterapia; Phone Number: +34689409432; Email: suarezi@clinic.cat
• Study Contact Backup: Name: Ines G Garcia, Fisioterapia; Phone Number: +34665538737

Study Locations

• Spain
  • Barcelona
    • Barcelona, Barcelona, Spain, 08036
      • Recruiting
      • Hospital Clinic De Barcelona
      • Contact: Maria S Suarez, Fisioterapia; Phone Number: +34689409432; Email: suarezi@clinic.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Conventional treatment
Experimental: Experimental; m-CIMT therapy	Behavioral: m-CIMT; m-CIMT therapy (healthy side restraint) and a specific upper limb exercise protocol.; Other Names: m-CIMT protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Basal, immediately after the intervention, 3 months after treatment

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2025
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 20, 2026

Study Registration Dates

• First Submitted: June 5, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 18, 2025

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: stroke; upper limb; m-CIMT; upper limb weakness
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: HCB/2024/1353

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We don't have the url with the information

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No