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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Clinic of Barcelona

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Ischaemic stroke.

Hospitalised patient (first 15 days).

Ability to understand and execute simple instructions.

Over 18 years of age.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • m-CIMT

    Behavioral

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

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: ExperimentalExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Basal, immediately after the intervention, 3 months after treatment
2

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.

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

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.

Time frame
3 months after treatment
4

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.

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

Secondary outcomes

1

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.

Time frame
Basal, immediately after the intervention, 3 months after treatment
2

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.

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

Other outcomes

Sponsors and contacts

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