Graded Motor Imagery for Patients Within a Year After Stroke.

Stroke Clinical Trial

— GMI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01993563
• Other study ID #: GMI_RCT_STROKE
• Status: Recruiting
• Phase: N/A
• First received: November 13, 2013
• Last updated: April 1, 2016
• Start date: September 2014
• Est. completion date: March 2017

Study information

• Verified date: April 2016
• Source: IRCCS San Camillo, Venezia, Italy
• Contact: Andrea Polli, MSc
• Phone: 3331304785
• Email: andrea.polli[@]ospedalesancamillo.net
• Is FDA regulated: No
• Health authority: Italy: Comitato Etico per la Sperimentazione dell'IRCCS San Camillo
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: March 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Camillo	Venice

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Camillo, Venezia, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No