HemiplegiaNCT01016496
New Perspectives in the Rehabilitation of Children With Motor Disorders : the Role of the Mirror Neuron System
A study testing action observation therapy and repetition of gestures in people with Hemiplegia and Cerebral Palsy, run by Stefania Costi at 3 sites in Italy.
Trial summary
Evidence exists that the activation of actions activates the same cortical motor areas that are involved in the performance of the observed actions. The neural substrate for this phenomena is the mirror neuron system. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Hemiplegia, Cerebral Palsy
- What is being tested?
- action observation therapy and repetition of gestures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesItaly
- Study dates
- Sep 2009to Nov 2010
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children with hemiplegia and
- Melbourne assessment > 50 points
Who cannot join
- inability to collaborate
- pharmacoresistant epilepsy
- inability to imitate gestures
- sensitivity disorders
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Hospital of Parma
Parma, Parma, 43100
IRCCS Stella Maris
Pisa, Pisa
Azienda Santa Maria Nuova -
Reggio Emilia, Reggio Emilia, 42100
About this study
Official title: Rehabilitation Strategies in Children With Neuro-motor Disorders Due to the Impairment of the Central Nervous System or the Peripheral Nervous System
Evidence exists that the activation of actions activates the same cortical motor areas that are involved in the performance of the observed actions. The neural substrate for this phenomena is the mirror neuron system. It is generally assumed that mirror neurons have a basic role in understanding the intentions of others and in imitation learning. There is evidence that action observation has a positive effect on rehabilitation of motor disorders after stroke. The aim of this study is to demonstrate that action observation followed by the repetition of the actions previously observed has a positive impact on rehabilitation of the upper limb in children affected by hemiplegia as a consequence of Cerebral Palsy. In particular, the purpose is to assess if mirror neurons could improve the amount, the quality and the velocity of movements and the cooperation between the two upper extremities.
- Conditions
- Hemiplegia, Cerebral Palsy
- Being tested
- action observation therapy, repetition of gestures
- Keywords
- Cerebral Palsy, Mirror neurons, hemiplegia, action observation therapy, children affected by hemiplegia as a consequence of Cerebral Palsy
- Medical subject headings
- Hemiplegia, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
action observation therapyOther
15 consecutive sessions of 18 minutes, plus repetition
repetition of gesturesOther
15 consecutive session of visual games, plus repetition of gestures
| Study group | Role | What they receive |
|---|---|---|
| Action observation plus repetition | Experimental | Observation of actions and repetition of the same actions Receives: Other: action observation therapy |
| repetition only | Active comparator | repetition of gestures Receives: Other: repetition of gestures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Melbourne Assessment of unilateral limb function
Measured: T0=baseline, Tend (week three) , T2(two months) T6months (six months after the completion of the training)
Secondary outcomes (3)
Assisting Hand Assessment
Measured: T0, Tend, T2, T6
Jebsen-Taylor
Measured: T0, Tend, T2, T6
Abilhand emikids
Measured: T0, Tend, T2, T6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2009 (estimated)
- Study startSep 2009
- Primary completionMay 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HemiplegiaStudies 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
- Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stefania Costi
- Sponsor type
- University, hospital or other
- Collaborators
- University of Parma, IRCCS Fondazione Stella Maris
- Responsible party
- Sponsor-investigator, Stefania Costi, University of Modena and Reggio Emilia
- Investigators
- Rizzolatti Giacomo, Professor, Principal investigator, University of ParmaFerrari Adriano, Professor, Study director, University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01016496
- Sponsor's protocol ID
- MIRROR_UDGEE_09
- Status last verified
- Jun 2014
- First submitted
- 18 Nov 2009
- Last updated
- 24 Jun 2014
- Results posted
- No
Publications
Sgandurra G, Biagi L, Fogassi L, Ferrari A, Sicola E, Guzzetta A, Tosetti M, Cioni G. Reorganization of action observation and sensory-motor networks after action observation therapy in children with congenital hemiplegia: A pilot study. Dev Neurobiol. 2020 Sep;80(9-10):351-360. doi: 10.1002/dneu.22783. Epub 2020 Oct 28.
PubMed 32986904Sgandurra G, Ferrari A, Cossu G, Guzzetta A, Biagi L, Tosetti M, Fogassi L, Cioni G. Upper limb children action-observation training (UP-CAT): a randomised controlled trial in hemiplegic cerebral palsy. BMC Neurol. 2011 Jun 28;11:80. doi: 10.1186/1471-2377-11-80.
PubMed 21711525
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation Strategies in Children With Neuro-motor Disorders Due to the Impairment of the Central Nervous System or the Peripheral Nervous System
- ClinicalTrials.gov ID
- NCT01016496
- Acronym / sponsor ID
- MIRROR_UDGEE_09
- Conditions
- Hemiplegia, Cerebral Palsy
- Keywords
- Cerebral Palsy, Mirror neurons, hemiplegia, action observation therapy, children affected by hemiplegia as a consequence of Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Stefania CostiUniversity, hospital or other
- Collaborators
- University of Parma, IRCCS Fondazione Stella Maris
- Study start
- Sep 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 19 Nov 2009 (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.
Evidence exists that the activation of actions activates the same cortical motor areas that are involved in the performance of the observed actions. The neural substrate for this phenomena is the mirror neuron system. It is generally assumed that mirror neurons have a basic role in understanding the intentions of others and in imitation learning. There is evidence that action observation has a positive effect on rehabilitation of motor disorders after stroke. The aim of this study is to demonstrate that action observation followed by the repetition of the actions previously observed has a positive impact on rehabilitation of the upper limb in children affected by hemiplegia as a consequence of Cerebral Palsy. In particular, the purpose is to assess if mirror neurons could improve the amount, the quality and the velocity of movements and the cooperation between the two upper extremities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Action observation plus repetition | Experimental | Other: action observation therapyObservation of actions and repetition of the same actions |
| repetition only | Active comparator | Other: repetition of gesturesrepetition of gestures |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children with hemiplegia and
- Melbourne assessment > 50 points
Key exclusion criteria (4 listed)
- inability to collaborate
- pharmacoresistant epilepsy
- inability to imitate gestures
- sensitivity disorders
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 |
|---|---|---|
| action observation therapy15 consecutive sessions of 18 minutes, plus repetition | Other | Action observation plus repetition |
| repetition of gestures15 consecutive session of visual games, plus repetition of gestures | Other | repetition only |
Primary outcome
Melbourne Assessment of unilateral limb function
Time frame: T0=baseline, Tend (week three) , T2(two months) T6months (six months after the completion of the training)
3 secondary outcomes
Assisting Hand Assessment
Time frame: T0, Tend, T2, T6
Jebsen-Taylor
Time frame: T0, Tend, T2, T6
Abilhand emikids
Time frame: T0, Tend, T2, T6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2014.
- Derived from this study: PubMed 32986904Sgandurra G, Biagi L, Fogassi L, Ferrari A, Sicola E, Guzzetta A, Tosetti M, Cioni G. Reorganization of action observation and sensory-motor networks after action observation therapy in children with congenital hemiplegia: A pilot study. Dev Neurobiol. 2020 Sep;80(9-10):351-360. doi: 10.1002/dneu.22783. Epub 2020 Oct 28.
- Derived from this study: PubMed 21711525Sgandurra G, Ferrari A, Cossu G, Guzzetta A, Biagi L, Tosetti M, Fogassi L, Cioni G. Upper limb children action-observation training (UP-CAT): a randomised controlled trial in hemiplegic cerebral palsy. BMC Neurol. 2011 Jun 28;11:80. doi: 10.1186/1471-2377-11-80.
Related trials for Hemiplegia
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Post-Stroke Apraxia, Motor Function, Balance, and Gait
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RecruitingObservational study
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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.
Rizzolatti Giacomo, Professor principal investigator
University of Parma
Ferrari Adriano, Professor study director
University of Modena and Reggio Emilia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing action observation therapy and repetition of gestures in people with Hemiplegia and Cerebral Palsy, run by Stefania Costi at 3 sites 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 24 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Melbourne Assessment of unilateral limb function (time frame: T0=baseline, Tend (week three) , T2(two months) T6months (six months after the completion of the training)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01016496, which also lists 2 linked publications.
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 24 Jun 2014.