An interventional study of mCIMT and hCIMT in Stroke, sponsored by University Hospital of Ferrara. Completed at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-12-20.
Sponsored by University Hospital of Ferrara · Not applicable, Interventional, and Treatment
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 20 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →University Hospital of Ferrara is the lead sponsor of 110 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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).
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
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
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital of Ferrara