Constraint-Induced Movement Therapy in Chronic Stroke Patients

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Behavioral: hCIMT; Behavioral: mCIMT

• Registration Number: NCT02345525
• Lead Sponsor: University Hospital of Ferrara

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.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2015-01-19
• Study First Submitted QC: 2015-01-23
• Study First Posted: 2015-01-26
• Primary Completion: 2017-05
• Study Completion: 2017-08
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-18
• Last Update Posted: 2017-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hCIMT	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.
mCIMT	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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
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.

Trial Locations

Locations (1)

Ferrara University Hospital; 🇮🇹 Ferrara, Italy