Isquemic Stroke, Upper Limb Weakness Due to Central Neurologic Injury
Conditions
Keywords
m-CIMT, stroke, upper limb weakness, upper limb
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.
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
BEHAVIORALm-CIMT
m-CIMT therapy (healthy side restraint) and a specific upper limb exercise protocol.
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Randomised, single-centre, single-blind, prospective, prospective clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| National Institutes of Health Stroke Scale (NIHSS) | 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. |
| Modified Rankin Scale (MRS) | 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. |
Countries
Spain
Contacts
Primary ContactMaria S Suarez, Fisioterapia
Backup ContactInes G Garcia, Fisioterapia
Outcome results
None listed