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
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Other: Graded Motor Imagery Other: Standard treatment||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
|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.
- 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.
- 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.
- 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
- 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.
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
|Contact: Andrea Polli, MSc||3331304785 ext firstname.lastname@example.org|
|IRCCS Ospedale San Camillo||Recruiting|
|Venice, Italy, 30126|
|Contact: Andrea Turolla, MSc 3283335170 ext 0039 email@example.com|
|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|
|Study Director:||Andrea Turolla, MSc||IRCCS Ospedale San Camillo|