New Perspectives in the Rehabilitation of Children With Motor Disorders : the Role of the Mirror Neuron System

Cerebral Palsy Clinical Trial

Official title:

Rehabilitation Strategies in Children With Neuro-motor Disorders Due to the Impairment of the Central Nervous System or the Peripheral Nervous System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01016496
• Other study ID #: MIRROR_UDGEE_09
• Status: Completed
• Phase: N/A
• First received: November 18, 2009
• Last updated: June 23, 2014
• Start date: September 2009
• Est. completion date: November 2010

Study information

• Verified date: June 2014
• Source: University of Modena and Reggio Emilia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• children with hemiplegia and

• Melbourne assessment > 50 points

Exclusion Criteria:

• inability to collaborate

• pharmacoresistant epilepsy

• inability to imitate gestures

• sensitivity disorders

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy
• Hemiplegia

Intervention

Other:
• action observation therapy
15 consecutive sessions of 18 minutes, plus repetition
• repetition of gestures
15 consecutive session of visual games, plus repetition of gestures

Locations

Country	Name	City	State
Italy	Hospital of Parma	Parma
Italy	IRCCS Stella Maris	Pisa
Italy	Azienda Santa Maria Nuova -	Reggio Emilia

Sponsors (3)

Lead Sponsor	Collaborator
Stefania Costi	IRCCS Fondazione Stella Maris, University of Parma

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Melbourne Assessment of unilateral limb function		T0=baseline, Tend (week three) , T2(two months) T6months (six months after the completion of the training)	No
Secondary	Assisting Hand Assessment		T0, Tend, T2, T6	No
Secondary	Jebsen-Taylor		T0, Tend, T2, T6	No
Secondary	Abilhand emikids		T0, Tend, T2, T6	No