- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07592650
Applicability and Effectiveness of Remote Occupational Therapy
11. maj 2026 opdateret af: Battaglia Domenica Immacolata, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
14
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Rome, Italien, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
population selected from family association groups
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Photosensitivity
- Organizational difficulties in the family that prevent the continuation of treatment
- Ongoing occupational treatment.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Patients
Intervention Group 1 CO-OP with the patient
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Parents
Intervention Group 2 CO-OP with the parents
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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effectiveness of a remote occupational therapy
Tidsramme: 5 months
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Evaluate the degree of improvement in self-perception of performance and satisfaction with goals achieved in therapy will be assessed during the clinical interview
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5 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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cognitive-behavioral profile
Tidsramme: 5 months
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Evaluate the results of any effects of the rehabilitation intervention on the cognitive-behavioral profile of patients, thanks to the standardised tests.
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5 months
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adaptive behavior.
Tidsramme: 5 months
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Verify the effects of remote occupational therapy on patients' adaptive behavior in daily life activities, thanks to a questionnaire
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5 months
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QOLIE-31
Tidsramme: 5 months
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Verify the effects of remote occupational therapy on patients' and their families' quality of life thanks to a questionnaire.
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5 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Domenica Immacolata Battaglia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
16. december 2021
Primær færdiggørelse (Faktiske)
1. juni 2022
Studieafslutning (Faktiske)
2. januar 2023
Datoer for studieregistrering
Først indsendt
2. marts 2023
Først indsendt, der opfyldte QC-kriterier
11. maj 2026
Først opslået (Faktiske)
18. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 3982
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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