Diplegic Cerebral PalsyNCT05223257
Action Observation in Children With Diplegic Cerebral Palsy
A study testing AOT in people with Diplegic Cerebral Palsy, run by IRCCS Fondazione Stella Maris at 3 sites in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Diplegic Cerebral Palsy
- What is being tested?
- AOT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 3 sitesItaly
- Study dates
- 1 Jun 2022to 16 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Exclusion criteria will be uncontrolled seizures and UL botulinum injections or orthopaedic surgery in the previous 6 months or during the study period.
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
University of Parma
Parma, 43125
IRCCS Fondazione Stella Maris
Pisa, 56128
IRCCS Reggio Emilia
Reggio Emilia, 42122
About this study
Official title: Action Observation Tele-rehabilitation for Upper Limb in Children With Diplegic Cerebral Palsy
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.
Read the 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:
- Intervention group (Experimental group). Children will receive immediately the system for 8 weeks.
- 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
- Diplegic Cerebral Palsy
- Being tested
- AOT
- Keywords
- Tele-rehabilitation, Action Observation, Mirror neurons, ICT
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AOTOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | AOT is based on the observation of meaningful actions followed by their execution Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
It is criterion-referenced test that measures unilateral upper extremity quality of movement in subjects with neurological impairments.
Measured: 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)
It measures unilateral gross manual dexterity. It is a quick, simple and inexpensive test. It can be used with a wide range of populations from childhood to adults.
Measured: 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
It will be done cognitive assessment with the Wechsler Intelligence Scale for Children (WISC) that is an individually administered intelligence test for children.
Measured: Baseline (T0, 1 week before beginning of the study)
Changes in neuropsychological assessment (social perception domain)
It will be done neuropsychological assessment with NEPSY-2 social perception domains, that measures the ability to: understand social contexts, interpret non verbal communication, form impressions of others, use contextual information to make inferences about others and their behaviour.
Measured: Baseline (T0, 1 week before beginning of the study)
Changes in neuropsychological assessment (sensory-motor domain)
It will be done neuropsychological assessment with NEPSY-2 sensory-motor domains, that consists of four tests that evaluate motor speed and precision, the ability to plan and execute movement sequences, bimanual and visuomotor coordination and imitation of movement.
Measured: 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)
Changes in BRIEF P
The Behavior Rating Inventory of Executive Function (BRIEF) measures the executive function in daily life context of children from the parents point of view. BRIEF P is for pre-school children.
Measured: 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)
Changes in BRIEF 2
The Behavior Rating Inventory of Executive Function (BRIEF) measures the executive function in daily life context of children from the parents point of view. BRIEF 2 is for school children.
Measured: 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)
Changes in ABILHAND-kids
A semi-structured item-response questionnaire that measures manual ability according to a caregiver's perceived difficulty performing daily bimanual tasks.
Measured: 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 Cerebral Palsy Quality of Life Questionnaire for Children (CP QOL -Child, 4-12 years)
This instrument is useful for evaluating interventions designed to improve the lives of children.
Measured: Baseline (T0) and T3 (24 weeks after the end of the training/control period)
Changes in Cerebral Palsy Quality of Life Questionnaire for Adolescents (CP QOL -Teen, 13-18 years)
This instrument is useful for evaluating interventions designed to improve the lives of adolescents.
Measured: Baseline (T0) and T3 (24 weeks after the end of the training/control period)
Changes in Participation and Environment Measure - Children and Youth (PEM-CY)
It is a measure that evaluates participation in the home, at school, and in the community, alongside environmental factors within each of these settings.
Measured: Baseline (T0) and T3 (16 weeks after T2)
Changes in Canadian occupational performance measure (COPM)
It is a validated measure that aims to identify rehabilitation needs in daily life and changes by the subject or his family.
Measured: 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 technological measurement of manual abilities by means of Virtual Reality Rehabilitation System (VRRS)
VRRS activities are aimed at estimating and evaluating the uni and bimanual activities, quantitatively through kinematic parameters.
Measured: 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 technological measurement of manual abilities by means of Upper Limb TRAcker system (ULTRA +)
ULTRA+ is a sensorized biomechatronic system equipped with an articulated arm with seven degrees of freedom. Kinematic and grip strength parameters will be obtained, thanks to a real immersion in a three-dimensional virtual environment.
Measured: 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)
Feasibility questionnaire
In order to investigate the feasibility of the system and the compliance of children and their families, will be carried out a questionnaire ad hoc at the end of the T1 assessment training in the experimental group.
Measured: T1 (within 1 week after the end of the training)
Changes in cerebral plasticity with fMRI (Functional Magnetic Resonance Imaging)
A subgroup of children, selected based on specific inclusion sub-criteria, will be asked to perform the fMRI examination before (T0) and immediately after the end of the experimental or standard treatment period (T1). The children will perform two tasks:
- Motor execution
- Action observation task In order to understand the feasibility of these tasks and the brain circuits involved during their execution, a group of typically developing children and healthy young adults will also be enrolled on a voluntary basis.
The fMRI study will evaluate the difference in intensity and extension of brain activation in relation to the rehabilitation intervention, as well as to demonstrate the effectiveness of the experimental rehabilitation intervention compared to the control one.
Measured: Baseline (T0, 1week before beginning of the study); T1 (within 1 week after the end of the training/control period)
Quantitative Changes in upper limbs activities detected with Actigraph GXT3+ during clinical assessment.
Actigraph GXT3+ worn during BoHA assessments
Measured: 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 daily life activities detected with Actigraph GXT3+
Quantitative measurement of daily manual activities
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start1 Jun 2022 (estimated)
- Primary completion16 Jun 2025 (estimated)
- Study completion16 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diplegic Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It will be a parallel RCT
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Fondazione Stella Maris
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda USL Reggio Emilia - IRCCS, University of Parma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223257
- Sponsor's protocol ID
- RF-2019-12370746
- Status last verified
- Mar 2022
- First submitted
- 17 Dec 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 21711525Buchignani 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.
PubMed 31881854Sgandurra 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.
PubMed 29764869Beani 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.
PubMed 32180754Sgandurra 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.
PubMed 32986904
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Action Observation Tele-rehabilitation for Upper Limb in Children With Diplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05223257
- Acronym / sponsor ID
- RF-2019-12370746
- Conditions
- Diplegic Cerebral Palsy
- Keywords
- Tele-rehabilitation, Action Observation, Mirror neurons, ICT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- IRCCS Fondazione Stella MarisUniversity, hospital or other
- Collaborators
- Azienda USL Reggio Emilia - IRCCS, University of Parma
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 16 Jun 2025 (estimated)
- Study completion
- 16 Sep 2025 (estimated)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Intervention group (Experimental group). Children will receive immediately the system for 8 weeks.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- It will be a parallel RCT
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: AOTAOT is based on the observation of meaningful actions followed by their execution |
| 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. |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Exclusion criteria will be uncontrolled seizures and UL botulinum injections or orthopaedic surgery in the previous 6 months or during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AOTObservation 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. | Other | Experimental group |
Primary outcome
Changes in the Both Hands Assessment (BoHA)
Time frame: 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)
This assessment measures bimanual performance in children with bilateral CP, during a semi-structured session with specific toys or activities.
18 secondary outcomes
Changes in Melbourne Assessment 2 (MA2)
Time frame: 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)
Time frame: 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
Time frame: Baseline (T0, 1 week before beginning of the study)
Changes in neuropsychological assessment (social perception domain)
Time frame: Baseline (T0, 1 week before beginning of the study)
Changes in neuropsychological assessment (sensory-motor domain)
Time frame: 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)
Changes in BRIEF P
Time frame: 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)
Changes in BRIEF 2
Time frame: 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)
Changes in ABILHAND-kids
Time frame: 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 Cerebral Palsy Quality of Life Questionnaire for Children (CP QOL -Child, 4-12 years)
Time frame: Baseline (T0) and T3 (24 weeks after the end of the training/control period)
Changes in Cerebral Palsy Quality of Life Questionnaire for Adolescents (CP QOL -Teen, 13-18 years)
Time frame: Baseline (T0) and T3 (24 weeks after the end of the training/control period)
Changes in Participation and Environment Measure - Children and Youth (PEM-CY)
Time frame: Baseline (T0) and T3 (16 weeks after T2)
Changes in Canadian occupational performance measure (COPM)
Time frame: 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 technological measurement of manual abilities by means of Virtual Reality Rehabilitation System (VRRS)
Time frame: 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 technological measurement of manual abilities by means of Upper Limb TRAcker system (ULTRA +)
Time frame: 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)
Feasibility questionnaire
Time frame: T1 (within 1 week after the end of the training)
Changes in cerebral plasticity with fMRI (Functional Magnetic Resonance Imaging)
Time frame: Baseline (T0, 1week before beginning of the study); T1 (within 1 week after the end of the training/control period)
Quantitative Changes in upper limbs activities detected with Actigraph GXT3+ during clinical assessment.
Time frame: 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 daily life activities detected with Actigraph GXT3+
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Background: PubMed 21711525Sgandurra 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.
- Background: PubMed 31881854Buchignani 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.
- Background: PubMed 29764869Sgandurra 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.
- Background: PubMed 32180754Beani 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.
- Background: PubMed 32986904Sgandurra 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AOT in people with Diplegic Cerebral Palsy, run by IRCCS Fondazione Stella Maris at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giuseppina Sgandurra, Dr. (+393392472874, g.sgandurra@fsm.unipi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Both Hands Assessment (BoHA) (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05223257, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.