Clinical trial NCT02345525: Constraint-Induced Movement Therapy in Chronic Stroke Patients
Official title: The Feasibility of a Home-based Constraint-Induced Movement Therapy Program in Chronic Stroke Survivors.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2015-01-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes from baseline in Fugl-Meyer Upper Extremity (FM-UE)
timeFrame: 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up
Secondary outcomes:
measure: Wolf Motor Function Test (WMFT)
timeFrame: 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up
measure: Nine Hole Peg Test (NHPT
timeFrame: 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up
measure: Motor Activity Log (MAL)
timeFrame: 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up
measure: Stroke Impact Scale 3.0 (SIS 3.0)
timeFrame: 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up
measure: Motor cortex excitability (single pulse and paired pulse TMS)
timeFrame: 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up
measure: 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.
timeFrame: 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Ferrara University Hospital
Study officials:
affiliation: Ospedale San Giorgio
name: Sofia Straudi, MD
role: PRINCIPAL_INVESTIGATOR
References: