Constraint-Induced Movement Therapy in Chronic Stroke Patients

Study Overview
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Brief Summary
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The aim of this study is to evaluate the feasibility of a Home-based Constraint-Induced Movement Therapy (hCIMT) compared to a Modified Constraint-Induced Movement Therapy (mCIMT) delivered in a outpatient setting on upper limb motor recovery in stroke survivors.

Detailed Description
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Home-based Constraint Induced Modified Therapy (hCIMT) consist of 2 hours intensive upper limb practice with shaping techniques + 2 hours ADLs supervised by a caregiver. Patients are supposed to wear a mitt on the unaffected hand for 4 hours daily. Modified Constraint Induced Modified Therapy (mCIMT) consist of 2 hours intensive upper limb practice with shaping techniques supervised by an experienced physiotherapist + 2 hours ADLs at home (supervised by a caregiver) Patients are supposed to wear a mitt on the unaffected hand for 4 hours daily.

Official Title
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The Feasibility of a Home-based Constraint-Induced Movement Therapy Program in Chronic Stroke Survivors.

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: mCIMT
* Behavioral: hCIMT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age > 18 years and < 80 years diagnosis of first ischemic stroke stroke onset > 6 months prior to study enrollment upper extremity hemiparesis with impairment of hand and/or arm: active wrist extension ≥20º active metacarpophalangeal- and interphalangeal-joints extension ≥ 10° muscle tone assessed by the Modified Ashworth Scale (MAS) ≤ 2 pain assessed by the Visual Analogue Scale (VAS) <4 Exclusion Criteria: anyone who does not have adequate understanding of verbal or written information in Italian sufficient to complete any test impaired cognitive functioning: score less than 24 on the Mini Mental Status Examination (MMSE) contraindications to single-pulse transcranial magnetic stimulation (TMS)(TMS will be used to measure cortical excitability): presence of a history of epilepsy, frequent headaches or neck pain, implantable devices (ventriculoperitoneal shunts, pacemakers, intrathecal pumps, intracranial metal implants) neurological or psychiatric pathology severe cardio-pulmonary, renal, hepatic diseases pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: mCIMT<br>2 hours intensive upper limb practice with shaping techniques supervised by an experienced physiotherapist + 2 hours ADLs at home (supervised by a caregiver) Patients are supposed to wear a mitt on the unaffected hand for 4 hours daily. | Behavioral: mCIMT<br>* This intervention is based on 3 main aspects: intensive training of functional tasks with the affected arm (massed practice) constraint of the un-affected hand through a mitt shaping techniques designed to transfer gains to the real world activities The 2 hours massed practice will be performed in a outpatient clinic with a supervision of PT.<br>|
| Experimental: hCIMT<br>2 hours intensive upper limb practice with shaping techniques + 2 hours ADLs supervised by a caregiver. Patients are supposed to wear a mitt on the unaffected hand for 4 hours daily. | Behavioral: hCIMT<br>* This intervention is based on 3 main aspects: intensive training of functional tasks with the affected arm (massed practice) constraint of the un-affected hand through a mitt shaping techniques designed to transfer gains to the real world activities In this group, a comprehensive set of the material necessary to perform the training at home and a booklet containing an explanation of the exercises that can be done will be provided to subjects. In addition, 2 hospital visits will be scheduled to instruct subjects and caregivers on the training and to update activities (1 visit at the beginning + 1 visit after 1 week).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in Fugl-Meyer Upper Extremity (FM-UE) | Measure of upper extremity motor impairment. The upper extremity score ranges from 0-66. | 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wolf Motor Function Test (WMFT) | Quantitative measure of upper extremity motor ability through timed and functional tasks. | 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up | 
| Nine Hole Peg Test (NHPT | Measures finger dexterity | 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up | 
| Motor Activity Log (MAL) | Assessment of the change in real-world arm use in activities of daily living. Subjects are asked to score the quality of movement as well as amount of use of the affected arm in a number of common daily activities. | 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up | 
| Stroke Impact Scale 3.0 (SIS 3.0) | Self-assessment questionnaire assesses health status following stroke | 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up | 
| Motor cortex excitability (single pulse and paired pulse TMS) | Single-Pulse TMS will be used to study cortical-spinal tract excitability in primary motor cortex (M1). Paired-pulse TMS Paired-Pulse TMS will be used to study intracortical excitability. | 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up | 
| NIRS (Near Infrared Spectroscopy) NIRS measurements will be performed during 6 cycles of 15s hand reaching and grasping and 45s resting while sitting on a chair. | For the NIRS it will use an 32-channel NIRS imaging equipment which consist of 16 pairs of emitting and detecting optical fibers attached to a custom-made head cap placed on primary motor cortex. NIRS measurements will be performed during 6 cycles of 15s hand reaching and grasping and 45s resting while sitting on a chair. | 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up |