Graded Motor Imagery for Patients Within a Year After Stroke.

Not Applicable

• Conditions: Stroke
• Interventions: Other: Graded Motor Imagery; Other: Standard treatment

• Registration Number: NCT01993563
• Lead Sponsor: IRCCS San Camillo, Venezia, Italy

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.

Study Timeline

• Study First Submitted: 2013-11-13
• Study First Submitted QC: 2013-11-22
• Study First Posted: 2013-11-25
• Study Start: 2014-09
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-01
• Last Update Posted: 2016-04-04
• Primary Completion: 2016-10
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Graded Motor Imagery	Graded Motor Imagery	-
Standard treatment	Standard treatment	-

Primary Outcome Measures

Name	Time	Method
Change in Wolf's Motor Function Test (WMFT)	before and after the 4-weeks treatment	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.
Change in Fugl Meyer Assessment Scale for upper extremity (FMA)	Before and after the 4-weeks treatment	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.

Secondary Outcome Measures

Name	Time	Method
Change in Functional Independence Measure (FIM)	before and after the 4-weeks treatment	FIM is an 18-item scale developed to assess severity of patient disability and medical rehabilitation functional outcome
Change in Transcranial Magnetic Stimulation (TMS)	before and after the 4-weeks treatment	In order to assess a possible neurophysiological effect of our treatment, we also evaluate cortical excitability using Single Stimulus TMS.

Trial Locations

Locations (1)

IRCCS Ospedale San Camillo; 🇮🇹 Venice, Italy