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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
This intervention is based on 3 main aspects: 1. intensive training of functional tasks with the affected arm (massed practice) 2. constraint of the un-affected hand through a mitt 3. 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.
This intervention is based on 3 main aspects: 1. intensive training of functional tasks with the affected arm (massed practice) 2. constraint of the un-affected hand through a mitt 3. 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).
Ferrara University Hospital
Ferrara, Italy
Changes from baseline in Fugl-Meyer Upper Extremity (FM-UE)
Measure of upper extremity motor impairment. The upper extremity score ranges from 0-66.
Time frame: 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up
Wolf Motor Function Test (WMFT)
Quantitative measure of upper extremity motor ability through timed and functional tasks.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up
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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.
Time frame: 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up