StrokeGMINCT01993563
Graded Motor Imagery for Patients Within a Year After Stroke.
A study testing Graded Motor Imagery and Standard treatment in people with Stroke, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Graded Motor Imagery and Standard treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2014to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale San Camillo
Venice, Italy, 30126
Andrea Turolla, MSc, 3283335170 ext. 0039, andrea.turolla@ospedalesancamillo.net
Andrea Polli, MSc
About this study
Official title: The Effect of a Graded Motor Imagery Approach for Stroke Patients Within a Year After Stroke
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.
Read the detailed description
Graded Motor Imagery is a graded approach recently proposed for treating chronic pain patients. It included three subsequent steps:
- Implicit Motor Imagery training (IMI), using a body part laterality discrimination task
- Explicit Motor Imagery training, using pictures and videos for improving patient's ability in imagining movements
- 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
- Being tested
- Graded Motor Imagery, Standard treatment
- Keywords
- Stroke, Rehabilitation, Motor Imagery, Upper Extremity, Mirror Therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graded Motor ImageryOther
Also called GMI
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 treatmentOther
Also called motor training, neurorehabilitation
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.
| Study group | Role | What they receive |
|---|---|---|
| Graded Motor Imagery | Experimental | Not described Receives: Other: Graded Motor Imagery |
| Standard treatment | Active comparator | Not described Receives: Other: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Before and after the 4-weeks treatment
Secondary outcomes (2)
Change in Functional Independence Measure (FIM)
FIM is an 18-item scale developed to assess severity of patient disability and medical rehabilitation functional outcome
Measured: before and after the 4-weeks treatment
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.
Measured: before and after the 4-weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startSep 2014
- Primary completionOct 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Camillo, Venezia, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Polli, IRCCS San Camillo, Venezia, Italy
- Investigators
- Andrea Turolla, MSc, Study director, IRCCS Ospedale San Camillo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993563
- Sponsor's protocol ID
- GMI_RCT_STROKE
- Acronym
- GMI
- Status last verified
- Apr 2016
- First submitted
- 13 Nov 2013
- Last updated
- 4 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Graded Motor Imagery Approach for Stroke Patients Within a Year After Stroke
- ClinicalTrials.gov ID
- NCT01993563
- Acronym / sponsor ID
- GMI / GMI_RCT_STROKE
- Conditions
- Stroke
- Keywords
- Stroke, Rehabilitation, Motor Imagery, Upper Extremity, Mirror Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- IRCCS San Camillo, Venezia, ItalyUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Implicit Motor Imagery training (IMI), using a body part laterality discrimination task
- Explicit Motor Imagery training, using pictures and videos for improving patient's ability in imagining movements
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Graded Motor Imagery | Experimental | Other: Graded Motor Imagery |
| Standard treatment | Active comparator | Other: Standard treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Graded Motor ImageryAlso: GMIGMI 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. | Other | Graded Motor Imagery |
| Standard treatmentAlso: motor training, neurorehabilitationPatients 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. | Other | Standard treatment |
Primary outcome
Change in Wolf's Motor Function Test (WMFT)
Time frame: 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)
Time frame: 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.
2 secondary outcomes
Change in Functional Independence Measure (FIM)
Time frame: before and after the 4-weeks treatment
Change in Transcranial Magnetic Stimulation (TMS)
Time frame: before and after the 4-weeks treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Turolla, MSc study director
IRCCS Ospedale San Camillo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graded Motor Imagery and Standard treatment in people with Stroke, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Polli, MSc (3331304785 ext. 0039, andrea.polli@ospedalesancamillo.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Wolf's Motor Function Test (WMFT) (time frame: before and after the 4-weeks treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2016.