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Constraint-Induced Movement Therapy in Chronic Stroke Patients

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
mCIMT
hCIMT
Sponsored by
University Hospital of Ferrara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Ferrara University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

mCIMT

hCIMT

Arm 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.

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.

Outcomes

Primary Outcome Measures

Changes from baseline in Fugl-Meyer Upper Extremity (FM-UE)
Measure of upper extremity motor impairment. The upper extremity score ranges from 0-66.

Secondary Outcome Measures

Wolf Motor Function Test (WMFT)
Quantitative measure of upper extremity motor ability through timed and functional tasks.
Nine Hole Peg Test (NHPT
Measures finger dexterity
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.
Stroke Impact Scale 3.0 (SIS 3.0)
Self-assessment questionnaire assesses health status following stroke
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.
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.

Full Information

First Posted
January 19, 2015
Last Updated
December 18, 2017
Sponsor
University Hospital of Ferrara
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1. Study Identification

Unique Protocol Identification Number
NCT02345525
Brief Title
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

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital of Ferrara

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mCIMT
Arm Type
Active Comparator
Arm 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.
Arm Title
hCIMT
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
mCIMT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
hCIMT
Intervention Description
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).
Primary Outcome Measure Information:
Title
Changes from baseline in Fugl-Meyer Upper Extremity (FM-UE)
Description
Measure of upper extremity motor impairment. The upper extremity score ranges from 0-66.
Time Frame
1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up
Secondary Outcome Measure Information:
Title
Wolf Motor Function Test (WMFT)
Description
Quantitative measure of upper extremity motor ability through timed and functional tasks.
Time Frame
1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up
Title
Nine Hole Peg Test (NHPT
Description
Measures finger dexterity
Time Frame
1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up
Title
Motor Activity Log (MAL)
Description
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.
Time Frame
1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up
Title
Stroke Impact Scale 3.0 (SIS 3.0)
Description
Self-assessment questionnaire assesses health status following stroke
Time Frame
1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up
Title
Motor cortex excitability (single pulse and paired pulse TMS)
Description
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.
Time Frame
1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up
Title
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.
Description
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.
Time Frame
1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sofia Straudi, MD
Organizational Affiliation
Ospedale San Giorgio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ferrara University Hospital
City
Ferrara
ZIP/Postal Code
44124
Country
Italy

12. IPD Sharing Statement

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Constraint-Induced Movement Therapy in Chronic Stroke Patients

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