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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mCIMT | Active Comparator | 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. |
|
| hCIMT | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mCIMT | Behavioral | This intervention is based on 3 main aspects:
The 2 hours massed practice will be performed in a outpatient clinic with a supervision of PT. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sofia Straudi, MD | Ospedale San Giorgio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ferrara University Hospital | Ferrara | 44124 | Italy |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| hCIMT | Behavioral | This intervention is based on 3 main aspects:
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). |
|
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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |