search
Back to results

Graded Motor Imagery for Patients Within a Year After Stroke. (GMI)

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Graded Motor Imagery
Standard treatment
Sponsored by
IRCCS San Camillo, Venezia, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Rehabilitation, Motor Imagery, Upper Extremity, Mirror Therapy

Eligibility Criteria

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

Inclusion Criteria:

  1. ischemic or hemorrhagic stroke within a year from the event;
  2. age of participant between 21 and 85 years old;
  3. absence of apraxia or global aphasia;
  4. Mini-Mental State Examination score >23.

Exclusion Criteria:

  1. Presence of other neurological or orthopaedic disorders affecting upper extremity motor function,
  2. Neglect,
  3. Significant spasticity defined as a score ≥ 24 total points at Tardieu Rating Scale (TRS)

Sites / Locations

  • IRCCS Ospedale San CamilloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Graded Motor Imagery

Standard treatment

Arm Description

Outcomes

Primary Outcome Measures

Change in Wolf's Motor Function Test (WMFT)
It includes 17 different tasks, which assess shoulder, elbow, wrist function and manual ability. For each task, a qualitative mark is given and time needed to complete the action is recorded.
Change in Fugl Meyer Assessment Scale for upper extremity (FMA)
We use the Upper Extremity session of the scale. The scale evaluates patient's balance, passive and active movements of shoulder, elbow, wrist and hand. It also evaluates different types of grips. Sense of position and ability to detect light touches are also evaluated.

Secondary Outcome Measures

Change in Functional Independence Measure (FIM)
FIM is an 18-item scale developed to assess severity of patient disability and medical rehabilitation functional outcome
Change in Transcranial Magnetic Stimulation (TMS)
In order to assess a possible neurophysiological effect of our treatment, we also evaluate cortical excitability using Single Stimulus TMS.

Full Information

First Posted
November 13, 2013
Last Updated
April 1, 2016
Sponsor
IRCCS San Camillo, Venezia, Italy
search

1. Study Identification

Unique Protocol Identification Number
NCT01993563
Brief Title
Graded Motor Imagery for Patients Within a Year After Stroke.
Acronym
GMI
Official Title
The Effect of a Graded Motor Imagery Approach for Stroke Patients Within a Year After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Camillo, Venezia, Italy

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of the study is to evaluate whether a graded rehabilitation approach including Implicit and explicit motor imagery training and mirror therapy is more effective than other treatments commonly provided in a neuro-rehabilitation department.
Detailed Description
Graded Motor Imagery is a graded approach recently proposed for treating chronic pain patients. It included three subsequent steps: Implicit Motor Imagery training (IMI), using a body part laterality discrimination task Explicit Motor Imagery training, using pictures and videos for improving patient's ability in imagining movements Mirror box therapy, using a 35x40 cm mirror, We are transferring this approach into stroke rehabilitation in order to improve patients' upper limb motor functions. All the patients, in both groups, will be training 2 hours a day, 5 days/week for 4 weeks. The first hour is standard treatment, the clinician in charge will decide treatment's priorities and the aim(s) of the treatment for each specific patient. The second hour will be focused on patient's upper limb function. The treatment group will be treated accordingly to the GMI protocol. The control group will receive a second hour of standard treatment, centred on the upper limb. Standard treatments are decided by the interdisciplinary team and might include motor rehabilitation, bilateral arm training, virtual reality training or occupational therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Rehabilitation, Motor Imagery, Upper Extremity, Mirror Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Graded Motor Imagery
Arm Type
Experimental
Arm Title
Standard treatment
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Graded Motor Imagery
Other Intervention Name(s)
GMI
Intervention Description
GMI program includes three steps: Implicit Motor Imagery (IMI); Explicit Motor Imagery (EMI) and Mirror Box Therapy (MT). IMI included a training based on Hand Laterality Discrimination Tasks. During these tasks 60 pictures of right and left hands are projected randomly on a 15" screen. Patients are asked to choose whether the images seen are right or left and therefore to click respectively the right or the left button on a mouse. EMI training consists in imagining a movement without actual performing it. It will be introduced during IMI's last two sessions and gradually enhanced increasing the complexity of motor skills to be imagined. The therapist shows or explains in details the movements the patient have to mentally rehearsed. MT treatments will start with simply watching the unaffected hand in the mirror and increased toward functional movement. When possible, gentle movement with the affected hand will be encouraged behind the reflecting part of the mirror.
Intervention Type
Other
Intervention Name(s)
Standard treatment
Other Intervention Name(s)
motor training, neurorehabilitation
Intervention Description
Patients will undergo to a standard treatment, that is thought to be the best option for that specific patients. In our hospital, treatment options include: motor training, functional training, occupational therapy, bilateral arm training or motor treatment using virtual reality devices.
Primary Outcome Measure Information:
Title
Change in Wolf's Motor Function Test (WMFT)
Description
It includes 17 different tasks, which assess shoulder, elbow, wrist function and manual ability. For each task, a qualitative mark is given and time needed to complete the action is recorded.
Time Frame
before and after the 4-weeks treatment
Title
Change in Fugl Meyer Assessment Scale for upper extremity (FMA)
Description
We use the Upper Extremity session of the scale. The scale evaluates patient's balance, passive and active movements of shoulder, elbow, wrist and hand. It also evaluates different types of grips. Sense of position and ability to detect light touches are also evaluated.
Time Frame
Before and after the 4-weeks treatment
Secondary Outcome Measure Information:
Title
Change in Functional Independence Measure (FIM)
Description
FIM is an 18-item scale developed to assess severity of patient disability and medical rehabilitation functional outcome
Time Frame
before and after the 4-weeks treatment
Title
Change in Transcranial Magnetic Stimulation (TMS)
Description
In order to assess a possible neurophysiological effect of our treatment, we also evaluate cortical excitability using Single Stimulus TMS.
Time Frame
before and after the 4-weeks treatment

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: ischemic or hemorrhagic stroke within a year from the event; age of participant between 21 and 85 years old; absence of apraxia or global aphasia; Mini-Mental State Examination score >23. Exclusion Criteria: Presence of other neurological or orthopaedic disorders affecting upper extremity motor function, Neglect, Significant spasticity defined as a score ≥ 24 total points at Tardieu Rating Scale (TRS)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Polli, MSc
Phone
3331304785
Ext
0039
Email
andrea.polli@ospedalesancamillo.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Turolla, MSc
Organizational Affiliation
IRCCS Ospedale San Camillo
Official's Role
Study Director
Facility Information:
Facility Name
IRCCS Ospedale San Camillo
City
Venice
ZIP/Postal Code
30126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Turolla, MSc
Phone
3283335170
Ext
0039
Email
andrea.turolla@ospedalesancamillo.net
First Name & Middle Initial & Last Name & Degree
Andrea Polli, MSc
First Name & Middle Initial & Last Name & Degree
Michela Agostini, BSc
First Name & Middle Initial & Last Name & Degree
Alfonc Baba, MSc
First Name & Middle Initial & Last Name & Degree
Andrea Turolla, MSc
First Name & Middle Initial & Last Name & Degree
Marianna Cavinato, PhD

12. IPD Sharing Statement

Learn more about this trial

Graded Motor Imagery for Patients Within a Year After Stroke.

We'll reach out to this number within 24 hrs