Menu
Recruiting NCT07233161

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

No phase Interventional Isquemic Stroke Upper Limb Weakness Due to Central Neurologic Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: m-CIMT.
Who it may be relevant to
Registry conditions: Isquemic Stroke, Upper Limb Weakness Due to Central Neurologic Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effectiveness of m-CIMT of the Upper Limb in Acute Post-stroke Patients.

Overview

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.

Interventions

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

Primary outcome measures

  • Fugl-Meyer [Time frame: Basal, immediately after the intervention, 3 months after treatment]
  • Abilhand [Time frame: Basal, immediately after the intervention, 3 months after treatment]
  • Motor Activity Log [Time frame: 3 months after treatment]
  • Fatigue Assessment Scale (FAS) [Time frame: Basal, immediately after the intervention, 3 months after treatment]
  • Stroke Impact Scale [Time frame: Basal,immediately after the intervention, 3 months after treatment]
Secondary outcome measures (2)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Hospital Clinic de Barcelona — Barcelona

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. PMID 25772900
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT07233161 · HCB/2024/1353

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗