Constraint-Induced Movement Therapy in Chronic Stroke Patients

NCT02345525 | Completed DMC

• 1 other identifier: Studio CIMT
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

mCIMT

ACTIVE COMPARATOR

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

hCIMT

EXPERIMENTAL

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

Interventions

mCIMT BEHAVIORAL

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.

mCIMT

hCIMT BEHAVIORAL

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).

hCIMT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (1)

Ferrara University Hospital

Ferrara, 44124, Italy

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sofia Straudi, MD

  Ospedale San Giorgio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2015
• First Posted: January 26, 2015
• Study Start: August 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: August 1, 2017
• Last Updated: December 20, 2017

Record last verified: 2017-12

Locations

IT (1)