NCT01016496

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 19, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

June 24, 2014

Status Verified

June 1, 2014

Enrollment Period

8 months

First QC Date

November 18, 2009

Last Update Submit

June 23, 2014

Conditions

HemiplegiaCerebral Palsy

Keywords

Cerebral PalsyMirror neuronshemiplegiaaction observation therapychildren affected by hemiplegia as a consequence of Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

  • Melbourne Assessment of unilateral limb function

    T0=baseline, Tend (week three) , T2(two months) T6months (six months after the completion of the training)

Secondary Outcomes (3)

  • Assisting Hand Assessment

    T0, Tend, T2, T6

  • Jebsen-Taylor

    T0, Tend, T2, T6

  • Abilhand emikids

    T0, Tend, T2, T6

Study Arms (2)

Action observation plus repetition

EXPERIMENTAL

Observation of actions and repetition of the same actions

Other: action observation therapy

repetition only

ACTIVE COMPARATOR

repetition of gestures

Other: repetition of gestures

Interventions

action observation therapyOTHER

15 consecutive sessions of 18 minutes, plus repetition

Action observation plus repetition
repetition of gesturesOTHER

15 consecutive session of visual games, plus repetition of gestures

repetition only

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children with hemiplegia and
  • Melbourne assessment \> 50 points

You may not qualify if:

  • inability to collaborate
  • pharmacoresistant epilepsy
  • inability to imitate gestures
  • sensitivity disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital of Parma

Parma, Parma, 43100, Italy

Location

IRCCS Stella Maris

Pisa, Pisa, Italy

Location

Azienda Santa Maria Nuova -

Reggio Emilia, Reggio Emilia, 42100, Italy

Location

Related Publications (2)

  • 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.

    PMID: 32986904DERIVED

  • Sgandurra 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.

    PMID: 21711525DERIVED

MeSH Terms

Conditions

HemiplegiaCerebral Palsy

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain Damage, ChronicBrain DiseasesCentral Nervous System Diseases

Study Officials

  • Rizzolatti Giacomo, Professor

    University of Parma

    PRINCIPAL INVESTIGATOR

  • Ferrari Adriano, Professor

    University of Modena and Reggio Emilia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
technician

Study Record Dates

First Submitted

November 18, 2009

First Posted

November 19, 2009

Study Start

September 1, 2009

Primary Completion

May 1, 2010

Study Completion

November 1, 2010

Last Updated

June 24, 2014

Record last verified: 2014-06

Locations

IT(3)