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OpenTrials
Completed

NCT Number: NCT07592650

Applicability and Effectiveness of Remote Occupational Therapy

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.

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Key information

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. cognitive-behavioral profile

    Time frame: 5 months

    Evaluate the results of any effects of the rehabilitation intervention on the cognitive-behavioral profile of patients, thanks to the standardised tests.

  2. adaptive behavior.

    Time frame: 5 months

    Verify the effects of remote occupational therapy on patients' adaptive behavior in daily life activities, thanks to a questionnaire

  3. QOLIE-31

    Time frame: 5 months

    Verify the effects of remote occupational therapy on patients' and their families' quality of life thanks to a questionnaire.

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Applicability and Effectiveness of Remote Occupational Therapy With Children and Adolescents With Dravet Syndrome and Their Families.

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
May 18, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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