SclerodermaNCT07661836
Personalized Online Occupational Therapy Intervention for Adults With Scleroderma
A study testing Personalized Online Occupational Therapy Intervention in people with Scleroderma and Scleroderma (Limited and Diffuse), run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scleroderma, Scleroderma (Limited and Diffuse), Systemic Sclerosis (SSc)
- What is being tested?
- Personalized Online Occupational Therapy Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 16 May 2026to 3 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Clinical condition or severe comorbidity preventing safe participation.
- Current residence outside Spain.
- Inability to provide informed consent or complete the baseline assessment.
- Concurrent participation in a specific occupational therapy program or another intensive, potentially interfering rehabilitation or therapeutic education intervention.
- Withdrawal of interest before the effective start of the intervention or inability to participate during the planned study dates.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Exploratory Parallel-Group Randomized Controlled Trial to Evaluate a Personalized Online Occupational Therapy Intervention Versus Usual Care in 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.
Read the detailed description
Scleroderma is a chronic connective tissue disease that may be associated with skin and visceral fibrosis, pain, fatigue, stiffness, respiratory symptoms, gastrointestinal symptoms, vascular alterations, and functional limitations. From an occupational perspective, these manifestations may affect activities of daily living, self-care, work, leisure, social participation, quality of life, hand function, and occupational balance.
This study is based on a previous cohort of adults with scleroderma in Spain, in which information was collected on functioning, quality of life, occupational balance, hand function, symptoms, assistive products, and unmet needs. The present phase aims to implement and preliminarily evaluate a personalized, occupation-centered, online occupational therapy intervention.
The study is a pilot exploratory parallel-group randomized controlled trial with individual allocation in a 1:1 ratio. It is coordinated by the University of Zaragoza and delivered remotely. Participants take part from their home or community environment in Spain. The intervention group receives eight individual online occupational therapy sessions, approximately 50-60 minutes each, twice weekly over four weeks, through Google Meet and without recording. The intervention is individualized according to baseline assessment and the first session, including personalized occupational goals using SMART criteria and Goal Attainment Scaling. The control group continues with usual care and does not receive additional intervention from the research team during the intervention and follow-up period. After completing follow-up, the control group will receive access to general educational materials and will be offered an online educational group session.
The primary feasibility outcome is the proportion of intervention-group participants who complete at least six of the eight planned sessions at post-intervention assessment. The pre-specified feasibility threshold is at least 70%. Secondary outcomes include acceptability, adherence, safety, and technical feasibility. Exploratory clinical and occupational outcomes include WHODAS 2.0, WHOQOL-BREF, Occupational Balance Questionnaire, Cochin Hand Function Scale, and Goal Attainment Scaling in the intervention group.
- Being tested
- Personalized Online Occupational Therapy Intervention, Usual Care
- Keywords
- Scleroderma, Systemic sclerosis, Occupational therapy, Telerehabilitation, Activities of daily living, Quality of life, Occupational balance, Hand function
- Medical subject headings
- Scleroderma, Diffuse, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Online Occupational Therapy InterventionBehavioural
The intervention consists of eight individual online occupational therapy sessions delivered over four weeks, with two sessions per week, through videoconference and without recording. Sessions are individualized according to baseline assessment, participant needs, and personalized occupational goals. The intervention may include goal setting using SMART criteria and Goal Attainment Scaling, hand preparation for occupation, self-care and pain management strategies, energy conservation, daily planning, environmental adaptations, assistive product guidance, occupational balance strategies, functional integration, and a maintenance plan. The intervention is delivered in addition to usual care.
Usual CareOther
Usual care refers to the ordinary health and social care that participants receive in their usual context. It is not administered by the research team. Participants allocated to this arm will not receive additional occupational therapy from the research team during the intervention and follow-up period. Changes in usual care will be recorded at post-intervention and follow-up assessments.
| Study group | Role | What they receive |
|---|---|---|
| Personalized Online Occupational Therapy Plus Usual Care | Experimental | Participants allocated to the intervention group will receive eight individual online occupational therapy sessions over four weeks, with two sessions per week, delivered by videoconference and added to usual care. Sessions will be individualized according to baseline assessment and participant goals and may include goal setting, hand preparation for occupation, self-care and pain management, energy conservation, daily planning, environmental adaptations, assistive product guidance, occupational balance, functional integration, and a maintenance plan. Sessions will not be recorded. Receives: Behavioral: Personalized Online Occupational Therapy Intervention |
| Usual Care | Active comparator | Participants allocated to the control group will continue with their usual health and social care during the intervention and follow-up period. They will not receive additional occupational therapy from the research team during this period. Changes in usual care will be recorded at post-intervention and follow-up assessments. After completing follow-up, participants in this arm will receive access to general educational materials and will be offered an online educational group session. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: intervention completion
Percentage of participants allocated to the intervention group who complete at least 6 of the 8 planned online occupational therapy sessions. The pre-specified feasibility threshold is 70% or higher.
Measured: From baseline to post-intervention, approximately 4 weeks.
Secondary outcomes (7)
Acceptability: session satisfaction
Participant satisfaction after each intervention session, assessed using Likert-type items scored from 1 to 5 and open-ended questions. Items address perceived usefulness, integration into daily routine, comprehension, self-efficacy, perceived safety, and suggestions for improvement.
Measured: After each intervention session during the 4-week intervention period.
Acceptability: final intervention satisfaction questionnaire score
Final satisfaction with the intervention will be assessed in the intervention group using a structured final intervention satisfaction questionnaire administered at post-intervention. The questionnaire includes Likert-type items scored from 1 to 5. A mean satisfaction score will be calculated across the Likert-type items, with higher scores indicating greater intervention acceptability and satisfaction.Open-ended questions will also be used to collect qualitative feedback on acceptability, perceived usefulness, and suggestions for improvement; these qualitative responses will be summarized descriptively and will not be included in the numerical score.
Measured: Post-intervention, approximately 4 weeks after baseline.
Complementary adherence: Percentage of expected weekly diaries completed
Complementary adherence will be assessed in the intervention group using the weekly participant diary. The outcome will be reported as the percentage of expected weekly diaries completed by each participant during the 4-week intervention period. Four weekly diaries are expected per participant. The percentage ranges from 0% to 100%, with higher percentages indicating greater adherence to weekly diary completion.
Measured: Weekly during the 4-week intervention period.
Complementary adherence: Percentage of agreed home-based tasks completed
Completion of agreed home-based tasks will be assessed in the intervention group using participant self-reports recorded in the weekly diary and adherence record. Each week, task completion will be recorded as completed, partially completed, or not completed. The outcome will be reported as the percentage of agreed home-based tasks completed during the intervention period. The percentage ranges from 0% to 100%, with higher percentages indicating greater adherence to the agreed home-based tasks.
Measured: Weekly during the 4-week intervention period and post-intervention, approximately 4 weeks after baseline.
Complementary adherence: Percentage of intervention materials reviewed
Review of intervention materials will be assessed in the intervention group using participant self-reports recorded in the weekly diary and adherence record. Each week, participants will report whether they reviewed the materials shared with them. The outcome will be reported as the percentage of intervention materials reviewed during the intervention period. The percentage ranges from 0% to 100%, with higher percentages indicating greater adherence to reviewing the intervention materials.
Measured: Weekly during the 4-week intervention period and post-intervention, approximately 4 weeks after baseline.
Safety: adverse events
Number of adverse events and number of participants with at least one adverse event, classified by severity, relationship with the intervention, outcome, and whether the event led to interruption, adaptation, or discontinuation of a session.
Measured: Continuously during the intervention period and at post-intervention and follow-up assessments, up to approximately 8 weeks after baseline.
Technical feasibility
Frequency, type, and impact of technical incidents affecting online intervention delivery, participant participation, or online data collection.
Measured: Continuously during the intervention period and assessment windows, up to approximately 8 weeks after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start16 May 2026
- Primary completion3 Aug 2026
- Study completion3 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SclerodermaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are individually randomized in a 1:1 ratio to either a personalized online occupational therapy intervention added to usual care or usual care alone.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Collaborators
- Asociación Española de Esclerodermia
- Responsible party
- Principal investigator, Sandra Martina Espín Tello, Universidad de Zaragoza
- Investigators
- Sandra M Espín Tello, PhD, Principal investigator, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661836
- Sponsor's protocol ID
- C.I. PI26/254
- Other IDs
- 216213
- Status last verified
- Oct 2026
- First submitted
- 10 Jun 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared due to the small sample size, the low prevalence of systemic sclerosis, and the potential risk of re-identification from the combination of sociodemographic, clinical, and occupational variables. Study findings will be disseminated only in aggregate form. General intervention materials and statistical code may be shared after review to remove any potentially identifiable information, but no individual participant-level dataset will be deposited in a public repository.
Publications
Lucas-Carrasco R. The WHO quality of life (WHOQOL) questionnaire: Spanish development and validation studies. Qual Life Res. 2012 Feb;21(1):161-5. doi: 10.1007/s11136-011-9926-3. Epub 2011 May 25.
PubMed 21611868Arreguin Reyes R, Lopez Lopez CO, Alvarez Hernandez E, Medrano Ramirez G, Montes Castillo Mde L, Vazquez-Mellado J. Evaluation of hand function in rheumatic disease. Validation and usefulness of the Spanish version AUSCAN, m-SACRAH and Cochin questionnaires. Reumatol Clin. 2012 Sep-Oct;8(5):250-4. doi: 10.1016/j.reuma.2012.03.005. Epub 2012 May 17.
PubMed 22609002Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. doi: 10.1023/B:QURE.0000018486.91360.00.
PubMed 15085902Peral-Gomez P, Lopez-Roig S, Pastor-Mira MA, Abad-Navarro E, Valera-Gran D, Hakansson C, Wagman P. Cultural Adaptation and Psychometric Properties of the Spanish Version of the Occupational Balance Questionnaire: An Instrument for Occupation-Based Research. Int J Environ Res Public Health. 2021 Jul 14;18(14):7506. doi: 10.3390/ijerph18147506.
PubMed 34299957Garin O, Ayuso-Mateos JL, Almansa J, Nieto M, Chatterji S, Vilagut G, Alonso J, Cieza A, Svetskova O, Burger H, Racca V, Francescutti C, Vieta E, Kostanjsek N, Raggi A, Leonardi M, Ferrer M; MHADIE consortium. Validation of the "World Health Organization Disability Assessment Schedule, WHODAS-2" in patients with chronic diseases. Health Qual Life Outcomes. 2010 May 19;8:51. doi: 10.1186/1477-7525-8-51.
PubMed 20482853Chan AW, Boutron I, Hopewell S, Moher D, Schulz KF, Collins GS, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne DR, Farmer AJ, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson DJ, Vohra S, White IR, Hrobjartsson A. SPIRIT 2025 statement: updated guideline for protocols of randomised trials. BMJ. 2025 Apr 28;389:e081477. doi: 10.1136/bmj-2024-081477.
PubMed 40294953
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Exploratory Parallel-Group Randomized Controlled Trial to Evaluate a Personalized Online Occupational Therapy Intervention Versus Usual Care in Adults With Scleroderma
- ClinicalTrials.gov ID
- NCT07661836
- Acronym / sponsor ID
- C.I. PI26/254
- Keywords
- Scleroderma, Systemic sclerosis, Occupational therapy, Telerehabilitation, Activities of daily living, Quality of life, Occupational balance, Hand function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Collaborators
- Asociación Española de Esclerodermia
- Study start
- 16 May 2026 (actual)
- Primary completion
- 3 Aug 2026 (actual)
- Study completion
- 3 Aug 2026 (actual)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Scleroderma is a chronic connective tissue disease that may be associated with skin and visceral fibrosis, pain, fatigue, stiffness, respiratory symptoms, gastrointestinal symptoms, vascular alterations, and functional limitations. From an occupational perspective, these manifestations may affect activities of daily living, self-care, work, leisure, social participation, quality of life, hand function, and occupational balance.
This study is based on a previous cohort of adults with scleroderma in Spain, in which information was collected on functioning, quality of life, occupational balance, hand function, symptoms, assistive products, and unmet needs. The present phase aims to implement and preliminarily evaluate a personalized, occupation-centered, online occupational therapy intervention.
The study is a pilot exploratory parallel-group randomized controlled trial with individual allocation in a 1:1 ratio. It is coordinated by the University of Zaragoza and delivered remotely. Participants take part from their home or community environment in Spain. The intervention group receives eight individual online occupational therapy sessions, approximately 50-60 minutes each, twice weekly over four weeks, through Google Meet and without recording. The intervention is individualized according to baseline assessment and the first session, including personalized occupational goals using SMART criteria and Goal Attainment Scaling. The control group continues with usual care and does not receive additional intervention from the research team during the intervention and follow-up period. After completing follow-up, the control group will receive access to general educational materials and will be offered an online educational group session.
The primary feasibility outcome is the proportion of intervention-group participants who complete at least six of the eight planned sessions at post-intervention assessment. The pre-specified feasibility threshold is at least 70%. Secondary outcomes include acceptability, adherence, safety, and technical feasibility. Exploratory clinical and occupational outcomes include WHODAS 2.0, WHOQOL-BREF, Occupational Balance Questionnaire, Cochin Hand Function Scale, and Goal Attainment Scaling in the intervention group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are individually randomized in a 1:1 ratio to either a personalized online occupational therapy intervention added to usual care or usual care alone.
| Arm | Type | Receives |
|---|---|---|
| Personalized Online Occupational Therapy Plus Usual Care | Experimental | Behavioral: Personalized Online Occupational Therapy InterventionParticipants allocated to the intervention group will receive eight individual online occupational therapy sessions over four weeks, with two sessions per week, delivered by videoconference and added to usual care. Sessions will be individualized according to baseline assessment and participant goals and may include goal setting, hand preparation for occupation, self-care and pain management, energy conservation, daily planning, environmental adaptations, assistive product guidance, occupational balance, functional integration, and a maintenance plan. Sessions will not be recorded. |
| Usual Care | Active comparator | Other: Usual CareParticipants allocated to the control group will continue with their usual health and social care during the intervention and follow-up period. They will not receive additional occupational therapy from the research team during this period. Changes in usual care will be recorded at post-intervention and follow-up assessments. After completing follow-up, participants in this arm will receive access to general educational materials and will be offered an online educational group session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- Clinical condition or severe comorbidity preventing safe participation.
- Current residence outside Spain.
- Inability to provide informed consent or complete the baseline assessment.
- Concurrent participation in a specific occupational therapy program or another intensive, potentially interfering rehabilitation or therapeutic education intervention.
- Withdrawal of interest before the effective start of the intervention or inability to participate during the planned study dates.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized Online Occupational Therapy InterventionThe intervention consists of eight individual online occupational therapy sessions delivered over four weeks, with two sessions per week, through videoconference and without recording. Sessions are individualized according to baseline assessment, participant needs, and personalized occupational goals. The intervention may include goal setting using SMART criteria and Goal Attainment Scaling, hand preparation for occupation, self-care and pain management strategies, energy conservation, daily planning, environmental adaptations, assistive product guidance, occupational balance strategies, functional integration, and a maintenance plan. The intervention is delivered in addition to usual care. | Behavioural | Personalized Online Occupational Therapy Plus Usual Care |
| Usual CareUsual care refers to the ordinary health and social care that participants receive in their usual context. It is not administered by the research team. Participants allocated to this arm will not receive additional occupational therapy from the research team during the intervention and follow-up period. Changes in usual care will be recorded at post-intervention and follow-up assessments. | Other | Usual Care |
Primary outcome
Feasibility: intervention completion
Time frame: From baseline to post-intervention, approximately 4 weeks.
Percentage of participants allocated to the intervention group who complete at least 6 of the 8 planned online occupational therapy sessions. The pre-specified feasibility threshold is 70% or higher.
7 secondary outcomes
Acceptability: session satisfaction
Time frame: After each intervention session during the 4-week intervention period.
Acceptability: final intervention satisfaction questionnaire score
Time frame: Post-intervention, approximately 4 weeks after baseline.
Complementary adherence: Percentage of expected weekly diaries completed
Time frame: Weekly during the 4-week intervention period.
Complementary adherence: Percentage of agreed home-based tasks completed
Time frame: Weekly during the 4-week intervention period and post-intervention, approximately 4 weeks after baseline.
Complementary adherence: Percentage of intervention materials reviewed
Time frame: Weekly during the 4-week intervention period and post-intervention, approximately 4 weeks after baseline.
Safety: adverse events
Time frame: Continuously during the intervention period and at post-intervention and follow-up assessments, up to approximately 8 weeks after baseline.
Technical feasibility
Time frame: Continuously during the intervention period and assessment windows, up to approximately 8 weeks after baseline.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Background: PubMed 21611868Lucas-Carrasco R. The WHO quality of life (WHOQOL) questionnaire: Spanish development and validation studies. Qual Life Res. 2012 Feb;21(1):161-5. doi: 10.1007/s11136-011-9926-3. Epub 2011 May 25.
- Background: PubMed 22609002Arreguin Reyes R, Lopez Lopez CO, Alvarez Hernandez E, Medrano Ramirez G, Montes Castillo Mde L, Vazquez-Mellado J. Evaluation of hand function in rheumatic disease. Validation and usefulness of the Spanish version AUSCAN, m-SACRAH and Cochin questionnaires. Reumatol Clin. 2012 Sep-Oct;8(5):250-4. doi: 10.1016/j.reuma.2012.03.005. Epub 2012 May 17.
- Background: PubMed 15085902Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. doi: 10.1023/B:QURE.0000018486.91360.00.
- Background: PubMed 34299957Peral-Gomez P, Lopez-Roig S, Pastor-Mira MA, Abad-Navarro E, Valera-Gran D, Hakansson C, Wagman P. Cultural Adaptation and Psychometric Properties of the Spanish Version of the Occupational Balance Questionnaire: An Instrument for Occupation-Based Research. Int J Environ Res Public Health. 2021 Jul 14;18(14):7506. doi: 10.3390/ijerph18147506.
- Background: PubMed 20482853Garin O, Ayuso-Mateos JL, Almansa J, Nieto M, Chatterji S, Vilagut G, Alonso J, Cieza A, Svetskova O, Burger H, Racca V, Francescutti C, Vieta E, Kostanjsek N, Raggi A, Leonardi M, Ferrer M; MHADIE consortium. Validation of the "World Health Organization Disability Assessment Schedule, WHODAS-2" in patients with chronic diseases. Health Qual Life Outcomes. 2010 May 19;8:51. doi: 10.1186/1477-7525-8-51.
- Background: PubMed 40294953Chan AW, Boutron I, Hopewell S, Moher D, Schulz KF, Collins GS, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne DR, Farmer AJ, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson DJ, Vohra S, White IR, Hrobjartsson A. SPIRIT 2025 statement: updated guideline for protocols of randomised trials. BMJ. 2025 Apr 28;389:e081477. doi: 10.1136/bmj-2024-081477.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared due to the small sample size, the low prevalence of systemic sclerosis, and the potential risk of re-identification from the combination of sociodemographic, clinical, and occupational variables. Study findings will be disseminated only in aggregate form. General intervention materials and statistical code may be shared after review to remove any potentially identifiable information, but no individual participant-level dataset will be deposited in a public repository.
Related trials for Scleroderma
Active, not recruiting
Patient Reported Outcomes With UVA-1 Therapy for Treatment of Sclerosing Skin Diseases
Scleroderma, Systemic, Morphea
Not yet recruitingPhase 1
A Phase 1 Study of QLS2416 Injection in Participants With Autoimmune Diseases
Systemic Lupus Erythematosus, Rheumatoid Arthritis (RA)
RecruitingPhase 1/2
A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)
Systemic Sclerosis, Idiopathic Inflammatory Myopathies
Active, not recruitingObservational study
Cross-cultural Adaptation and Validation of the Localised Scleroderma Quality of Life Instrument (LoSQI) in Juvenile Localised Scleroderma (JLS)
Scleroderma
Recruiting
Tissue Modeling in Systemic Sclerosis Using Induced Pluripotent Stem Cells (iPSCs)
Systemic Sclerosis (SSc)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra M Espín Tello, PhD principal investigator
Universidad de Zaragoza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Online Occupational Therapy Intervention in people with Scleroderma and Scleroderma (Limited and Diffuse), run by Universidad de Zaragoza at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: intervention completion (time frame: From baseline to post-intervention, approximately 4 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07661836, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.