Stroke
Conditions
Brief summary
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
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.
Interventions
BEHAVIORALmCIMT
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.
BEHAVIORALhCIMT
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).
Sponsors
University Hospital of Ferrara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in Fugl-Meyer Upper Extremity (FM-UE) | 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up | Measure of upper extremity motor impairment. The upper extremity score ranges from 0-66. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nine Hole Peg Test (NHPT | 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up | Measures finger dexterity |
| Motor Activity Log (MAL) | 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up | 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. |
| Wolf Motor Function Test (WMFT) | 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up | Quantitative measure of upper extremity motor ability through timed and functional tasks. |
| Motor cortex excitability (single pulse and paired pulse TMS) | 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up | 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. |
| 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. | 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up | 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. |
| Stroke Impact Scale 3.0 (SIS 3.0) | 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up | Self-assessment questionnaire assesses health status following stroke |
Countries
Italy
Outcome results
None listed