Constraint-Induced Movement Therapy in Chronic Stroke Patients

The Feasibility of a Home-based Constraint-Induced Movement Therapy Program in Chronic Stroke Survivors.

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Behavioral: mCIMT; Behavioral: hCIMT

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Ferrara, Italy, 44124
    • Ferrara University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: mCIMT; This intervention is based on 3 main aspects: intensive training of functional tasks with the affected arm (massed practice); constraint of the un-affected hand through a mitt; 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.
Experimental: 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.	Behavioral: hCIMT; This intervention is based on 3 main aspects: intensive training of functional tasks with the affected arm (massed practice); constraint of the un-affected hand through a mitt; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline in Fugl-Meyer Upper Extremity (FM-UE)	Measure of upper extremity motor impairment. The upper extremity score ranges from 0-66.	1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wolf Motor Function Test (WMFT)	Quantitative measure of upper extremity motor ability through timed and functional tasks.	1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up
Nine Hole Peg Test (NHPT	Measures finger dexterity	1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up
Motor Activity Log (MAL)	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.	1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up
Stroke Impact Scale 3.0 (SIS 3.0)	Self-assessment questionnaire assesses health status following stroke	1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up
Motor cortex excitability (single pulse and paired pulse TMS)	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.	1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up
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.	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.	1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up

Collaborators and Investigators

• Sponsor: University Hospital of Ferrara
• Investigators: Principal Investigator: Sofia Straudi, MD, Ospedale San Giorgio

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: January 19, 2015
• First Submitted That Met QC Criteria: January 23, 2015
• First Posted (Estimate): January 26, 2015

Study Record Updates

• Last Update Posted (Actual): December 20, 2017
• Last Update Submitted That Met QC Criteria: December 18, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: Studio CIMT