Dravet SyndromeNCT07592650
Applicability and Effectiveness of Remote Occupational Therapy
An observational study of Dravet Syndrome, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The pandemic has made it necessary to imagine and experiment with new ways for disabled patients to continue their care, responding to the sudden employment and emotional void of this historical period. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Dravet Syndrome
- How many people
- 14 participants
- Where
- 1 siteItaly
- Study dates
- 16 Dec 2021to 2 Jan 2023
- Phase
- Observational
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: population selected from family association groups
Who may be able to join
- Diagnosis of Dravet Syndrome.
- Ages 7-18 years.
- Sufficient cognitive and behavioral skills to set goals and participate in treatment
- Access and manageability with respect to using a PC/tablet with a stable Internet connection
- Sufficient language/communication skills to follow simple instructions and interact with therapist
- Willingness/ability of a parent/caregiver in the family to attend all treatment sessions and involve themselves in "parent coaching." It will be necessary to maintain the same parent for the duration of the course.
Who cannot join
- Photosensitivity
- Organizational difficulties in the family that prevent the continuation of treatment
- Ongoing occupational treatment.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, 00168
About this study
Official title: Applicability and Effectiveness of Remote Occupational Therapy With Children and Adolescents With Dravet Syndrome and Their Families.
The pandemic has made it necessary to imagine and experiment with new ways for disabled patients to continue their care, responding to the sudden employment and emotional void of this historical period. With this in mind, several studies have shown how telemedicine and telerehabilitation can represent a new frontier in care, reducing costs, shortening distances, increasing continuity of care, and also allowing services to be performed in a comfortable and familiar environment. All these elements also combine to determine a positive effect on the patient's compliance with the therapeutic project, in which he or she finally feels like a protagonist. It is evident that the application of these modalities in the pediatric patient requires the maximum cooperation from the family. In this regard, it has been shown that despite the complexity associated with managing a patient with Dravet syndrome, families want to be involved, showing readiness to invest and participate in meaningful activities for their children.Considering the persistence of the national health emergency and the demonstrated effectiveness of remote occupational therapy in patients with behavioral and adaptive frameworks similar to Dravet patients, it is deemed interesting to test the feasibility of an occupational therapy project following the CO-OP approach (with the child or with the parent) also in this specific population. Moreover, when considering the care gap given by the small number of recognized professionals in the field of occupational therapy and the uneven distribution of such a service across the territory at the expense of rural and disadvantaged areas, remote occupational therapy could be a significant resource for families of children and youth with disabilities even beyond the boundaries of the current COVID emergency.
- Conditions
- Dravet Syndrome
- Keywords
- Dravet, occupational therapy
- Medical subject headings
- Epilepsies, Myoclonic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Intervention Group 1 CO-OP with the patient | |
| Parents | Intervention Group 2 CO-OP with the parents |
What is being measured
The primary outcome is the main question the study is designed to answer.
effectiveness of a remote occupational therapy
Evaluate the degree of improvement in self-perception of performance and satisfaction with goals achieved in therapy will be assessed during the clinical interview
Measured: 5 months
Secondary outcomes (3)
cognitive-behavioral profile
Evaluate the results of any effects of the rehabilitation intervention on the cognitive-behavioral profile of patients, thanks to the standardised tests.
Measured: 5 months
adaptive behavior.
Verify the effects of remote occupational therapy on patients' adaptive behavior in daily life activities, thanks to a questionnaire
Measured: 5 months
QOLIE-31
Verify the effects of remote occupational therapy on patients' and their families' quality of life thanks to a questionnaire.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start16 Dec 2021
- Primary completion1 Jun 2022
- Study completion2 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dravet SyndromeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Battaglia Domenica Immacolata, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Domenica Immacolata Battaglia, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07592650
- Sponsor's protocol ID
- 3982
- Status last verified
- May 2026
- First submitted
- 2 Mar 2023
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applicability and Effectiveness of Remote Occupational Therapy With Children and Adolescents With Dravet Syndrome and Their Families.
- ClinicalTrials.gov ID
- NCT07592650
- Acronym / sponsor ID
- 3982
- Conditions
- Dravet Syndrome
- Keywords
- Dravet, occupational therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 16 Dec 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 2 Jan 2023 (actual)
- First posted
- 18 May 2026 (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.
The pandemic has made it necessary to imagine and experiment with new ways for disabled patients to continue their care, responding to the sudden employment and emotional void of this historical period. With this in mind, several studies have shown how telemedicine and telerehabilitation can represent a new frontier in care, reducing costs, shortening distances, increasing continuity of care, and also allowing services to be performed in a comfortable and familiar environment. All these elements also combine to determine a positive effect on the patient's compliance with the therapeutic project, in which he or she finally feels like a protagonist. It is evident that the application of these modalities in the pediatric patient requires the maximum cooperation from the family. In this regard, it has been shown that despite the complexity associated with managing a patient with Dravet syndrome, families want to be involved, showing readiness to invest and participate in meaningful activities for their children.Considering the persistence of the national health emergency and the demonstrated effectiveness of remote occupational therapy in patients with behavioral and adaptive frameworks similar to Dravet patients, it is deemed interesting to test the feasibility of an occupational therapy project following the CO-OP approach (with the child or with the parent) also in this specific population. Moreover, when considering the care gap given by the small number of recognized professionals in the field of occupational therapy and the uneven distribution of such a service across the territory at the expense of rural and disadvantaged areas, remote occupational therapy could be a significant resource for families of children and youth with disabilities even beyond the boundaries of the current COVID emergency.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Intervention Group 1 CO-OP with the patient |
| Parents | – | –Intervention Group 2 CO-OP with the parents |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- population selected from family association groups
Key inclusion criteria (6 listed)
- Diagnosis of Dravet Syndrome.
- Ages 7-18 years.
- Sufficient cognitive and behavioral skills to set goals and participate in treatment
- Access and manageability with respect to using a PC/tablet with a stable Internet connection
- Sufficient language/communication skills to follow simple instructions and interact with therapist
Key exclusion criteria (3 listed)
- Photosensitivity
- Organizational difficulties in the family that prevent the continuation of treatment
- Ongoing occupational treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
effectiveness of a remote occupational therapy
Time frame: 5 months
Evaluate the degree of improvement in self-perception of performance and satisfaction with goals achieved in therapy will be assessed during the clinical interview
3 secondary outcomes
cognitive-behavioral profile
Time frame: 5 months
adaptive behavior.
Time frame: 5 months
QOLIE-31
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
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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.
Domenica Immacolata Battaglia principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dravet Syndrome, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site 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 3 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: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effectiveness of a remote occupational therapy (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2026.