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NCT Number: NCT07233161

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

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.

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Key information

Conditions

Isquemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Upper Limb Weakness Due to Central Neurologic Injury Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location status: Recruiting

Location contact

Maria S Suarez, Fisioterapia

CONTACT

[email protected]

+34689409432

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

m-CIMT

Behavioral

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

Other names: m-CIMT protocol

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Modified Rankin Scale (MRS)

    Time frame: Basal, immediately after the intervention, 3 months after treatment

    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.

  2. National Institutes of Health Stroke Scale (NIHSS)

    Time frame: Basal, immediately after the intervention, 3 months after treatment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ines G Garcia, Fisioterapia

CONTACT

+34665538737

Maria S Suarez, Fisioterapia

CONTACT

[email protected]

+34689409432

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

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

Acronym: m-CIMT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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