Action Observation in Children With Diplegic Cerebral Palsy
NCT ID: NCT05223257
Last Updated: 2022-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
54 participants
INTERVENTIONAL
2022-06-01
2025-09-16
Brief Summary
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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.
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Detailed Description
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1. Intervention group (Experimental group). Children will receive immediately the system for 8 weeks.
2. Standard care group (Control group). Children will continue standard care At the end of the project, if the study results will be positive, children enrolled in the control group will be able to have the same treatment as the experimental group, if necessary.
The system will provide an in-home, individualized, intensive treatment based on the AOT. The system will be delivered at home and the children will perform a 60-minute training session at least 5 days a week for 8 consecutive weeks (total of 40 hours).
Follow-up assessment (outcome measures) will be conducted before (T0) and post-intervention at 1 weeks (T1), and then 8 and 24 weeks after the AOT intervention/standard care (T2 and T3).
The primary endpoint will be T1. Clinical assessments will be administered by a therapist blind to group assignment in each centre. Scoring of videotaped clinical outcome measures will be performed by therapists blind to group allocation and assessment order.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Experimental group
AOT is based on the observation of meaningful actions followed by their execution
AOT
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.
Control group
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.
No interventions assigned to this group
Interventions
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AOT
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
5 Years
16 Years
ALL
No
Sponsors
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IRCCS reggio emilia
UNKNOWN
University of Parma
OTHER
IRCCS Fondazione Stella Maris
OTHER
Responsible Party
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Locations
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University of Parma
Parma, , Italy
IRCCS Fondazione Stella Maris
Pisa, , Italy
IRCCS Reggio Emilia
Reggio Emilia, , Italy
Countries
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Central Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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RF-2019-12370746
Identifier Type: -
Identifier Source: org_study_id
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