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

The Effect of a Graded Motor Imagery Approach for Stroke Patients Within a Year After Stroke

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.

Study Overview

• Status: Unknown
• Conditions: Stroke
• Intervention / Treatment: Other: Graded Motor Imagery; Other: Standard treatment

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
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Venice, Italy, 30126
    • Recruiting
    • IRCCS Ospedale San Camillo
    • Contact: Andrea Turolla, MSc; Phone Number: 0039 3283335170; Email: 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	before and after the 4-weeks treatment
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.	Before and after the 4-weeks treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Functional Independence Measure (FIM)	FIM is an 18-item scale developed to assess severity of patient disability and medical rehabilitation functional outcome	before and after the 4-weeks treatment
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.	before and after the 4-weeks treatment

Collaborators and Investigators

• Sponsor: IRCCS San Camillo, Venezia, Italy
• Investigators: Study Director: Andrea Turolla, MSc, IRCCS Ospedale San Camillo

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): October 1, 2016
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: November 13, 2013
• First Submitted That Met QC Criteria: November 22, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Estimate): April 4, 2016
• Last Update Submitted That Met QC Criteria: April 1, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Rehabilitation; Stroke; Upper Extremity; Motor Imagery; Mirror Therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: GMI_RCT_STROKE