Applicability and Effectiveness of Remote Occupational Therapy

NCT07592650 | Completed

• 1 other identifier: 3982
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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

  5 months

Secondary Outcomes (3)

• cognitive-behavioral profile

  5 months

• adaptive behavior.

  5 months

• QOLIE-31

  5 months

Study Arms (2)

Patients

Intervention Group 1 CO-OP with the patient

Parents

Intervention Group 2 CO-OP with the parents

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

population selected from family association groups

You may qualify if:

• 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.

You may not qualify if:

• Photosensitivity
• Organizational difficulties in the family that prevent the continuation of treatment
• Ongoing occupational treatment.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Epilepsies, Myoclonic

Condition Hierarchy (Ancestors)

Epilepsy, Generalized; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes

Study Officials

• Domenica Immacolata Battaglia

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: May 18, 2026
• Study Start: December 16, 2021
• Primary Completion: June 1, 2022
• Study Completion: January 2, 2023
• Last Updated: May 18, 2026

Record last verified: 2026-05

Locations

IT (1)