Action Observation in Children With Diplegic Cerebral Palsy

NCT05223257 | Unknown DMC

• 1 other identifier: RF-2019-12370746
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 3

Brief Summary

A new rehabilitative approach, called AOT, based on the discovery of mirror neuron system (MNS), has been used with promising results on the Upper Limb (UL) function in some studies in children with Cerebral Palsy (CP). The purpose of the present trial is to provide evidence by an RCT, preceded by a pilot study, that customized and home based AOT training is an effective rehabilitation tool in children with diplegic CP (DCP) and that its effects are greater than standard care. Both Hands Assessment (BoHA) is chosen as primary outcome measure and a sample size of 27 per group is required. The rehabilitation lasting 8 weeks will be provided at home by an ICT platform able to deliver, manage, monitor and measure a personalized AOT.

Conditions

Diplegic Cerebral Palsy

Keywords

Tele-rehabilitation; Action Observation; Mirror neurons; ICT

Outcome Measures

Primary Outcomes (1)

• Changes in the Both Hands Assessment (BoHA)

  This assessment measures bimanual performance in children with bilateral CP, during a semi-structured session with specific toys or activities.

  Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the training/control period); T2 (8 weeks after the end of the training/control period) and T3 (24 weeks after the end of the training/control period)

Secondary Outcomes (18)

• Changes in Melbourne Assessment 2 (MA2)

  Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the training/control period); T2 (8 weeks after the end of the training/control period) and T3 (24 weeks after the end of the training/control period)

• Changes in Box and Block Test (BBT)

  Baseline (T0, 1week before beginning of the study); T1 (within 1 week after the end of the training/control period); T2 (8 weeks after the end of the training/control period) and T3 (24 weeks after the end of the training/control period)

• Changes in cognitive assessment

  Baseline (T0, 1 week before beginning of the study)

• Changes in neuropsychological assessment (social perception domain)

  Baseline (T0, 1 week before beginning of the study)

• Changes in neuropsychological assessment (sensory-motor domain)

  Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the training/control period); T3 (24 weeks after the end of the training/control period)

Study Arms (2)

Experimental group

EXPERIMENTAL

AOT is based on the observation of meaningful actions followed by their execution

Other: AOT

Control group

NO INTERVENTION

Children will continue standard care for 8 weeks Subject allocated to "standard care" group will have to continue what they normally do; they (if \> 13 years) or their parents will have to fill a diary in which they will write the rehabilitative activities they do, specifying their intensity and whether these activities are more focused on the lower limbs or upper limbs.

Interventions

AOT OTHER

Observation of video sequences showing unimanual and bimanual goal-directed actions followed by the execution of the observed actions with upper limbs for unimanual and bimanual actions.

Experimental group

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• diagnosis of diplegic cerebral palsy (DCP) (GMFCS level I to IV - children may have been achieved an independent gait)
• age between 5 and 16 years
• MACS level I-IV
• sufficient cooperation and communicative understanding to perform assessments and participate in the intervention
• caregivers able to commit and collaborate in a rehabilitative intensive home
• subjects and parents able to commit to the intensive rehabilitation program for a period of 8 weeks.

Sponsors & Collaborators

• IRCCS Fondazione Stella Maris: lead
• IRCCS reggio emilia: collaborator
• University of Parma: collaborator

Study Sites (3)

University of Parma

Parma, 43125, Italy

Location

IRCCS Fondazione Stella Maris

Pisa, 56128, Italy

Location

IRCCS Reggio Emilia

Reggio Emilia, 42122, Italy

Location

Related Publications (5)

• 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: 21711525 BACKGROUND

• Buchignani B, Beani E, Pomeroy V, Iacono O, Sicola E, Perazza S, Bieber E, Feys H, Klingels K, Cioni G, Sgandurra G. Action observation training for rehabilitation in brain injuries: a systematic review and meta-analysis. BMC Neurol. 2019 Dec 27;19(1):344. doi: 10.1186/s12883-019-1533-x.

  PMID: 31881854 BACKGROUND

• Sgandurra G, Cecchi F, Beani E, Mannari I, Maselli M, Falotico FP, Inguaggiato E, Perazza S, Sicola E, Feys H, Klingels K, Ferrari A, Dario P, Boyd RN, Cioni G. Tele-UPCAT: study protocol of a randomised controlled trial of a home-based Tele-monitored UPper limb Children Action observation Training for participants with unilateral cerebral palsy. BMJ Open. 2018 May 14;8(5):e017819. doi: 10.1136/bmjopen-2017-017819.

  PMID: 29764869 BACKGROUND

• Beani E, Menici V, Ferrari A, Cioni G, Sgandurra G. Feasibility of a Home-Based Action Observation Training for Children With Unilateral Cerebral Palsy: An Explorative Study. Front Neurol. 2020 Feb 28;11:16. doi: 10.3389/fneur.2020.00016. eCollection 2020.

  PMID: 32180754 BACKGROUND

• 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: 32986904 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Giuseppina Sgandurra, Dr.

CONTACT

+393392472874; g.sgandurra@fsm.unipi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: It will be a parallel RCT

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: February 3, 2022
• Study Start: June 1, 2022
• Primary Completion: June 16, 2025
• Study Completion: September 16, 2025
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

IT (3)