Clinical trial NCT01993563: Graded Motor Imagery for Patients Within a Year After Stroke.
Official title: The Effect of a Graded Motor Imagery Approach for Stroke Patients Within a Year After Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Stroke
Rehabilitation
Motor Imagery
Upper Extremity
Mirror Therapy
Lead sponsor: IRCCS San Camillo, Venezia, Italy
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change in Wolf's Motor Function Test (WMFT)
timeFrame: before and after the 4-weeks treatment
measure: Change in Fugl Meyer Assessment Scale for upper extremity (FMA)
timeFrame: Before and after the 4-weeks treatment
Secondary outcomes:
measure: Change in Functional Independence Measure (FIM)
timeFrame: before and after the 4-weeks treatment
measure: Change in Transcranial Magnetic Stimulation (TMS)
timeFrame: before and after the 4-weeks treatment
Other outcomes:
Locations:
city: Venice
country: Italy
facility: IRCCS Ospedale San Camillo
Study officials:
affiliation: IRCCS Ospedale San Camillo
name: Andrea Turolla, MSc
role: STUDY_DIRECTOR
References: