Constraint-Induced Movement Therapy in Chronic Stroke Patients
NCT ID: NCT02345525
Last Updated: 2017-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2014-08-31
2017-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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mCIMT
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.
mCIMT
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.
hCIMT
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.
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
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).
Interventions
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mCIMT
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.
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
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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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University Hospital of Ferrara
OTHER
Responsible Party
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Principal Investigators
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Sofia Straudi, MD
Role: PRINCIPAL_INVESTIGATOR
Ospedale San Giorgio
Locations
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Ferrara University Hospital
Ferrara, , Italy
Countries
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Other Identifiers
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Studio CIMT
Identifier Type: -
Identifier Source: org_study_id