Graded Motor Imagery for Patients Within a Year After Stroke.

NCT ID: NCT01993563

Last Updated: 2016-04-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2017-03-31

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:

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Graded Motor Imagery

Group Type: EXPERIMENTAL

Graded Motor Imagery

Intervention Type: OTHER

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

Group Type: ACTIVE_COMPARATOR

Standard treatment

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

GMI; motor training; neurorehabilitation

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS San Camillo, Venezia, Italy

OTHER

Sponsor Role: lead

Responsible Party

Andrea Polli

MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Turolla, MSc

Role: STUDY_DIRECTOR

IRCCS Ospedale San Camillo

Locations

IRCCS Ospedale San Camillo

Venice, Italy, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Andrea Polli, MSc

Role: CONTACT

andrea.polli@ospedalesancamillo.net

3331304785 ext. 0039

Facility Contacts

Andrea Turolla, MSc

Role: primary

andrea.turolla@ospedalesancamillo.net

3283335170 ext. 0039

Other Identifiers

GMI_RCT_STROKE

Identifier Type: -

Identifier Source: org_study_id