Clinical Trials in Spain / NCT07233161
Recruiting
Not applicable
Effectiveness of m-CIMT of the Upper Limb in Acute Post-stroke Patients. (m-CIMT, Modified Constraint-induced Movement Therapy)
NCT07233161 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Isquemic StrokeUpper Limb Weakness Due to Central Neurologic Injury
Investigational drug(s) / intervention(s)
m-CIMT
m-CIMT: m-CIMT therapy (healthy side restraint) and a specific upper limb exercise protocol.
Study 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.
Eligibility
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.
Primary outcome measure(s)
- Fugl-Meyer — 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. - Abilhand — 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. - Motor Activity Log — 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. - Fatigue Assessment Scale (FAS) — 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. - Stroke Impact Scale — 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Hospital Clinic de Barcelona | Barcelona | Barcelona | Recruiting |
More Hospital Clinic of Barcelona trials in Spain
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07233161 on ClinicalTrials.gov ↗ ← All trials in Spain