Graded Motor Imagery for Patients Within a Year After Stroke.

NCT01993563 | Unknown DMC

• 1 other identifier: GMI_RCT_STROKE
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; Rehabilitation; Motor Imagery; Upper Extremity; Mirror Therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in Functional Independence Measure (FIM)

  before and after the 4-weeks treatment

• Change in Transcranial Magnetic Stimulation (TMS)

  before and after the 4-weeks treatment

Study Arms (2)

Graded Motor Imagery

EXPERIMENTAL

Other: Graded Motor Imagery

Standard treatment

ACTIVE COMPARATOR

Other: Standard treatment

Interventions

Graded Motor Imagery 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.

Also known as: GMI

Graded Motor Imagery

Standard treatment 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.

Also known as: motor training, neurorehabilitation

Standard treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ischemic or hemorrhagic stroke within a year from the event;
• age of participant between 21 and 85 years old;
• absence of apraxia or global aphasia;
• Mini-Mental State Examination score \>23.

You may not qualify if:

• Presence of other neurological or orthopaedic disorders affecting upper extremity motor function,
• Neglect,
• Significant spasticity defined as a score ≥ 24 total points at Tardieu Rating Scale (TRS)

Sponsors & Collaborators

• IRCCS San Camillo, Venezia, Italy: lead

Study Sites (1)

IRCCS Ospedale San Camillo

Venice, Italy, 30126, Italy

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Neurological Rehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Andrea Turolla, MSc

  IRCCS Ospedale San Camillo

  STUDY DIRECTOR

Central Study Contacts

Andrea Polli, MSc

CONTACT

3331304785; andrea.polli@ospedalesancamillo.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Study Record Dates

• First Submitted: November 13, 2013
• First Posted: November 25, 2013
• Study Start: September 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: March 1, 2017
• Last Updated: April 4, 2016

Record last verified: 2016-04

Locations

IT (1)