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

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ClinicalTrials.gov Identifier: NCT01993563
Recruitment Status : Unknown
Verified April 2016 by Andrea Polli, IRCCS San Camillo, Venezia, Italy.
Recruitment status was:  Recruiting
First Posted : November 25, 2013
Last Update Posted : April 4, 2016
Sponsor:
Information provided by (Responsible Party):
Andrea Polli, IRCCS San Camillo, Venezia, Italy

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.

Condition or disease Intervention/treatment Phase
Stroke Other: Graded Motor Imagery Other: Standard treatment Not Applicable

Detailed Description:

Graded Motor Imagery is a graded approach recently proposed for treating chronic pain patients. It included three subsequent steps:

  1. Implicit Motor Imagery training (IMI), using a body part laterality discrimination task
  2. Explicit Motor Imagery training, using pictures and videos for improving patient's ability in imagining movements
  3. 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of a Graded Motor Imagery Approach for Stroke Patients Within a Year After Stroke
Study Start Date : September 2014
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : March 2017

Arm Intervention/treatment
Experimental: Graded Motor Imagery Other: Graded Motor Imagery

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.

Other Name: GMI

Active Comparator: Standard treatment Other: Standard treatment
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.
Other Names:
  • motor training
  • neurorehabilitation




Primary Outcome Measures :
  1. Change in Wolf's Motor Function Test (WMFT) [ Time Frame: before and after the 4-weeks treatment ]
    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.

  2. Change in Fugl Meyer Assessment Scale for upper extremity (FMA) [ Time Frame: Before and after the 4-weeks treatment ]
    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 :
  1. Change in Functional Independence Measure (FIM) [ Time Frame: before and after the 4-weeks treatment ]
    FIM is an 18-item scale developed to assess severity of patient disability and medical rehabilitation functional outcome

  2. Change in Transcranial Magnetic Stimulation (TMS) [ Time Frame: before and after the 4-weeks treatment ]
    In order to assess a possible neurophysiological effect of our treatment, we also evaluate cortical excitability using Single Stimulus TMS.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993563


Contacts
Contact: Andrea Polli, MSc 3331304785 ext 0039 andrea.polli@ospedalesancamillo.net

Locations
Italy
IRCCS Ospedale San Camillo Recruiting
Venice, Italy, 30126
Contact: Andrea Turolla, MSc    3283335170 ext 0039    andrea.turolla@ospedalesancamillo.net   
Principal Investigator: Andrea Polli, MSc         
Sub-Investigator: Michela Agostini, BSc         
Sub-Investigator: Alfonc Baba, MSc         
Sub-Investigator: Andrea Turolla, MSc         
Sub-Investigator: Marianna Cavinato, PhD         
Sponsors and Collaborators
IRCCS San Camillo, Venezia, Italy
Investigators
Study Director: Andrea Turolla, MSc IRCCS Ospedale San Camillo

Responsible Party: Andrea Polli, MSc, IRCCS San Camillo, Venezia, Italy
ClinicalTrials.gov Identifier: NCT01993563     History of Changes
Other Study ID Numbers: GMI_RCT_STROKE
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: April 4, 2016
Last Verified: April 2016

Keywords provided by Andrea Polli, IRCCS San Camillo, Venezia, Italy:
Stroke
Rehabilitation
Motor Imagery
Upper Extremity
Mirror Therapy

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases