Patients Hospitalized in a FRC DepartmentSASNCT03116204
Validation of a SOFMER Activity Scale
An observational study of Patients Hospitalized in a FRC Department, run by Hospices Civils de Lyon at 9 sites in France.
Trial summary
A person's dependency is defined as the total or partial inability to perform without helps the necessary activities of daily life due to activity limitations in the usual environment. The consequence is a restriction of participation. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Patients Hospitalized in a FRC Department
- What is being tested?
- Assessment of score SAS
- How many people
- 152 participants
- Where
- 9 sitesFrance
- Study dates
- 21 Nov 2018to 19 Oct 2021
- Phase
- Observational
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients hospitalized in a FRC department
Who may be able to join
- Men and women aged 2 years old
- Hospitalized in the participating department for at least 4 days
- For the responsiveness study : patients hospitalized in the FRC departments for obesity, spinal cord injuries, post-stroke rehabilitation or cardiorespiratory rehabilitation after cardiac surgery
Who cannot join
- Non-recipient of French Social Security
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Centre SSR Les Capucins
Angers
Etablissement Hopale-Centre Calvé
Berck
Service SSRS Enfants et Adolescents, Fondation Ildys
Brest
Département de Rééducation Neurologique - Hôpital Sud - CHU de Grenoble
Échirolles
Médecine physique et réadaptation - Hôpital Raymond Poincaré - APHP
Garche
Ctre Médico-Chir Réadapt Des Massues
Lyon
Service de Médecine physique et Réadaptation - Hôpital Henry Gabrielle
Lyon
Service de Médecine Physique et de Réadaptation - F.Widal - APHP
Paris
Service de Médecine Physique et Réadaptation - Pôle Couple Mère-Enfant - HOPITAL DE BELLEVUE
Saint-Etienne
About this study
Official title: Validation of a Score Assessing Physical and Cognitive Activities of Patients in Follow-up Care and Rehabilitation Departments: the SOFMER Activity Score
A person's dependency is defined as the total or partial inability to perform without helps the necessary activities of daily life due to activity limitations in the usual environment. The consequence is a restriction of participation. In physical and Rehabilitation Medicine (PRM), dependency impacts the healthcare team activity at several levels: patient's referral and care plan, conditions of home return and resumption of course of life, burden of care assessment and care teams management...
The main goal of this project is the validation of a score assessing physical and cognitive activities of patients in follow-up care and rehabilitation (FRC) departments based on the ICF model (International Classification of Functioning, Disability and Health) : the SOFMER Activity Scale (SAS).
We want to propose a French generic scale allowing quantifying precisely the dependence and burden of care of patients in FRC departments. This scale needs to be valid, easy to apply, easy to learn, reproducible, sensitive to change and common to adult subjects, children and elderly.
- Being tested
- Assessment of score SAS
- Keywords
- Dependency, FRC department, scale validation, validity, reliability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of score SASOther
Assessment of a score assessing physical and cognitive activities of patients in follow-up care and rehabilitation departments
| Study group | Role | What they receive |
|---|---|---|
| Patients hospitalized in a FRC department | Not described Receives: Other: Assessment of score SAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the validity of SAS
The construct validity will be determined by an exploratory factor analysis and confirmed on an independent sample.
Criterion validity will be studied by comparison of scores obtained from SAS to scores obtained from references scale (FIM, WeeFIM, ADL, IADL, BREF, BREV, MMSE and items of WISC IV).
Measured: Day 0
Assessment of the reliability of SAS.
For the inter rater reliability study, patients will be rated on the same day by two groups of therapists.
For the test-retest reliability study, patients will be rated twice during their hospitalization, within a time frame sufficiently close so that their dependency should not change.
Measured: Day 7
Secondary outcomes (2)
Study of SAS responsiveness
Sensitivity to change will be studied on patients hospitalized in a FRC departments for obesity, spinal cord injuries, post-stroke rehabilitation or cardiorespiratory rehabilitation after cardiac surgery. The change between scores of SAS at entry and exit (or at maximum 6 months after inclusion) of hospitalization will be studied.
Measured: 6 months
Study of invariance of SAS: invariance of the classification between age and sex classes.
Invariance of SAS will be determined between three age classes (<18 years, 18-75 years,> 75 years) using three confirmatory factor analyzes
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start21 Nov 2018
- Primary completion19 Oct 2021
- Study completion19 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Hospitalized in a FRC DepartmentStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carole VUILLEROT, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03116204
- Sponsor's protocol ID
- 69HCL17_0027
- Acronym
- SAS
- Status last verified
- Oct 2025
- First submitted
- 11 Apr 2017
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Score Assessing Physical and Cognitive Activities of Patients in Follow-up Care and Rehabilitation Departments: the SOFMER Activity Score
- ClinicalTrials.gov ID
- NCT03116204
- Acronym / sponsor ID
- SAS / 69HCL17_0027
- Keywords
- Dependency, FRC department, scale validation, validity, reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- 19 Oct 2021 (actual)
- Study completion
- 19 Oct 2021 (actual)
- First posted
- 14 Apr 2017 (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.
A person's dependency is defined as the total or partial inability to perform without helps the necessary activities of daily life due to activity limitations in the usual environment. The consequence is a restriction of participation. In physical and Rehabilitation Medicine (PRM), dependency impacts the healthcare team activity at several levels: patient's referral and care plan, conditions of home return and resumption of course of life, burden of care assessment and care teams management...
The main goal of this project is the validation of a score assessing physical and cognitive activities of patients in follow-up care and rehabilitation (FRC) departments based on the ICF model (International Classification of Functioning, Disability and Health) : the SOFMER Activity Scale (SAS).
We want to propose a French generic scale allowing quantifying precisely the dependence and burden of care of patients in FRC departments. This scale needs to be valid, easy to apply, easy to learn, reproducible, sensitive to change and common to adult subjects, children and elderly.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients hospitalized in a FRC department | – | Other: Assessment of score SAS |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients hospitalized in a FRC department
Key inclusion criteria (3 listed)
- Men and women aged 2 years old
- Hospitalized in the participating department for at least 4 days
- For the responsiveness study : patients hospitalized in the FRC departments for obesity, spinal cord injuries, post-stroke rehabilitation or cardiorespiratory rehabilitation after cardiac surgery
Key exclusion criteria (1 listed)
- Non-recipient of French Social Security
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 |
|---|---|---|
| Assessment of score SASAssessment of a score assessing physical and cognitive activities of patients in follow-up care and rehabilitation departments | Other | Patients hospitalized in a FRC department |
Primary outcome
Assessment of the validity of SAS
Time frame: Day 0
The construct validity will be determined by an exploratory factor analysis and confirmed on an independent sample. Criterion validity will be studied by comparison of scores obtained from SAS to scores obtained from references scale (FIM, WeeFIM, ADL, IADL, BREF, BREV, MMSE and items of WISC IV).
Assessment of the reliability of SAS.
Time frame: Day 7
For the inter rater reliability study, patients will be rated on the same day by two groups of therapists. For the test-retest reliability study, patients will be rated twice during their hospitalization, within a time frame sufficiently close so that their dependency should not change.
2 secondary outcomes
Study of SAS responsiveness
Time frame: 6 months
Study of invariance of SAS: invariance of the classification between age and sex classes.
Time frame: day 0
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 6 Oct 2025.
- Individual participant dataSharing planned: No
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.
Carole VUILLEROT principal investigator
Hospices Civils de Lyon
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Hospitalized in a FRC Department, run by Hospices Civils de Lyon at 9 sites in France.
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 3 inclusion and 1 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 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. 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?
Assessment of the validity of SAS (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2025.