Personalized Online Occupational Therapy Intervention for Adults With Scleroderma

This pilot exploratory randomized controlled trial will evaluate the feasibility, acceptability, and safety of a personalized online occupational therapy intervention for adults with scleroderma in Spain. Participants will be individually randomized in a 1:1 ratio to either an online occupational therapy intervention added to usual care or usual care alone. The intervention consists of eight individual online occupational therapy sessions delivered over four weeks, with two sessions per week, plus individualized materials. The control group will continue with usual care during the intervention and follow-up period. Outcomes will be assessed at baseline, post-intervention, and four weeks after the end of the intervention. The primary outcome is feasibility, defined as the proportion of participants in the intervention group who complete at least six of the eight planned sessions. Secondary and exploratory outcomes include acceptability, adherence, safety, technical feasibility, functioning, quality of life, occupational balance, hand function, and individual goal attainment.

NCT Number	NCT07661836
Lead Sponsor	Universidad de Zaragoza Collaborators: Asociación Española de Esclerodermia
Conditions	Scleroderma, Scleroderma (Limited and Diffuse), Systemic Sclerosis (SSc)
Enrollment	24 participants
Start Date	2026-05-16
Primary Completion	2026-07 (estimated)
Study Completion	2026-08 (estimated)
Updated on ClinicalTrials.gov	2026-06-22