Clinical trial NCT05223257: Action Observation in Children With Diplegic Cerebral Palsy
Official title: Action Observation Tele-rehabilitation for Upper Limb in Children With Diplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diplegic Cerebral Palsy
Keywords: Tele-rehabilitation
Action Observation
Mirror neurons
ICT
Lead sponsor: IRCCS Fondazione Stella Maris
Sponsor class: OTHER
Collaborators: name: IRCCS reggio emilia
name: University of Parma
First posted: 2022-02-03
Enrollment: 54
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It will be a parallel RCT
Primary purpose: TREATMENT

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.

Detailed description: A two-arm, evaluator-blinded, randomized trial (RCT), preceded by a pilot study, will be conducted according to CONSORT guidelines. Each participant will be randomized to either:

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Exclusion criteria will be uncontrolled seizures and UL botulinum injections or orthopaedic surgery in the previous 6 months or during the study period.

Primary outcomes:
measure: Changes in the Both Hands Assessment (BoHA)
timeFrame: 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:
measure: Changes in Melbourne Assessment 2 (MA2)
timeFrame: 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)
measure: Changes in Box and Block Test (BBT)
timeFrame: 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)
measure: Changes in cognitive assessment
timeFrame: Baseline (T0, 1 week before beginning of the study)
measure: Changes in neuropsychological assessment (social perception domain)
timeFrame: Baseline (T0, 1 week before beginning of the study)
measure: Changes in neuropsychological assessment (sensory-motor domain)
timeFrame: 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)
measure: Changes in BRIEF P
timeFrame: 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)
measure: Changes in BRIEF 2
timeFrame: 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)
measure: Changes in ABILHAND-kids
timeFrame: 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)
measure: Changes in Cerebral Palsy Quality of Life Questionnaire for Children (CP QOL -Child, 4-12 years)
timeFrame: Baseline (T0) and T3 (24 weeks after the end of the training/control period)
measure: Changes in Cerebral Palsy Quality of Life Questionnaire for Adolescents (CP QOL -Teen, 13-18 years)
timeFrame: Baseline (T0) and T3 (24 weeks after the end of the training/control period)
measure: Changes in Participation and Environment Measure - Children and Youth (PEM-CY)
timeFrame: Baseline (T0) and T3 (16 weeks after T2)
measure: Changes in Canadian occupational performance measure (COPM)
timeFrame: 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)
measure: Changes in technological measurement of manual abilities by means of Virtual Reality Rehabilitation System (VRRS)
timeFrame: 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)
measure: Changes in technological measurement of manual abilities by means of Upper Limb TRAcker system (ULTRA +)
timeFrame: 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)
measure: Feasibility questionnaire
timeFrame: T1 (within 1 week after the end of the training)
measure: Changes in cerebral plasticity with fMRI (Functional Magnetic Resonance Imaging)
timeFrame: Baseline (T0, 1week before beginning of the study); T1 (within 1 week after the end of the training/control period)
measure: Quantitative Changes in upper limbs activities detected with Actigraph GXT3+ during clinical assessment.
timeFrame: 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)
measure: Changes in daily life activities detected with Actigraph GXT3+
timeFrame: During training and/or standard period (from T0 to T1) (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the training/control period)
Other outcomes:
Locations:
city: Parma
country: Italy
facility: University of Parma
city: Pisa
country: Italy
facility: IRCCS Fondazione Stella Maris
city: Reggio Emilia
country: Italy
facility: IRCCS Reggio Emilia
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.