Constraint-Induced Movement Therapy in Chronic Stroke Patients

University Hospital of Ferrara

Status: Completed

Conditions: Stroke

Treatments: Behavioral: hCIMT; Behavioral: mCIMT

Study type: Interventional

Funder types: Other

Identifiers

NCT02345525

Studio CIMT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

mCIMT

Active Comparator group

Description:

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.

Treatment:

Behavioral: mCIMT

hCIMT

Experimental group

Description:

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.

Treatment:

Behavioral: hCIMT