NCT07661836Completed
Personalized Online Occupational Therapy Intervention for Adults With Scleroderma
Pilot Exploratory Parallel-Group Randomized Controlled Trial to Evaluate a Personalized Online Occupational Therapy Intervention Versus Usual Care in Adults With Scleroderma
Source: ClinicalTrials.gov · Last updated 14 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 24 (actual)
- First submitted
- 10 Jun 2026
- Start date
- 16 May 2026
- Primary completion date
- 3 Aug 2026
- Lead sponsor
- Universidad de Zaragoza
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT07661836
What you commit to
- Study type: Interventional
- Participants enrolled: 24
- From 16 May 2026 to the primary completion date, 3 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent participation in a specific occupational therapy program or another intensive, potentially interfering rehabilitation or therapeutic education intervention.
Other illness
- Clinical condition or severe comorbidity preventing safe participation.
Other
- Current residence outside Spain.
- Inability to provide informed consent or complete the baseline assessment.
- Withdrawal of interest before the effective start of the intervention or inability to participate during the planned study dates.
Who the study is looking for
- Adults aged 18 years or older with scleroderma from the previous project cohort and meeting the general eligibility criteria of the initial study.
- Current residence in Spain.
- Sufficient Spanish language ability to provide informed consent, participate in the intervention, and complete study assessments.
- Ability to understand the study information and provide informed consent, with support if needed.
- Access to the internet and to a device compatible with Google Meet and Hefora.
- Availability to participate in eight online sessions of approximately 60 minutes, twice weekly over four weeks.
- Not currently participating in a specific occupational therapy program or another intervention that could substantially influence functioning, activities of daily living, quality of life, or occupational balance.
- Provision of informed consent and completion of the baseline assessment.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universidad de Zaragoza Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.