Joint(S) DegenerationRAAPCNCT05134038
Association Between Fear of Falling and Spinal Stiffness.
An observational study of Joint(S) Degeneration and Old Age; Atrophy, run by Hopital of Melun at 1 site in France.
Trial summary
1. / evaluation of the fear of falling using an FES-I questionnaire, distribution of subjects according to the score into 3 groups (16-19: little concerned by the fear of falling, 20-27 moderately concerned, 28-64 very concerned by fear of falling) 2. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Joint(S) Degeneration, Old Age; Atrophy, Fear of Injury
- What is being tested?
- anthropomorphic measurements
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2021to 1 Jan 2023
- 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 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: > 75 ans, in any geriatric department of the hospital
Who may be able to join
- over 75 years old,
- Ability to understand and answer a questionnaire in French
- Ability to stand up
- Patient from the Melun hospital (santé pole center + nursing home of the GHSIF)
- Affiliated with a social security scheme
Who cannot join
- mental disorders,
- lumbar surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: L'impact De La Raideur Articulaire Pelvienne Sur La Peur De Chuter Du Sujet Âgé Hospitalisé Ou En Institution.
- / evaluation of the fear of falling using an FES-I questionnaire, distribution of subjects according to the score into 3 groups (16-19: little concerned by the fear of falling, 20-27 moderately concerned, 28-64 very concerned by fear of falling)
- / evaluation of lumbar articular mobility by the schober index, coxofemoral by hip goniometry in flexion and extension (no evaluation of other amplitudes because lack of abduction / abduction / external and internal rotation of the hip remain functional in walking and the balance)
Read the detailed description
- / evaluation of the fear of falling using an FES-I questionnaire, distribution of subjects according to the score into 3 groups (16-19: little concerned by the fear of falling, 20-27 moderately concerned, 28-64 very concerned by fear of falling)
- / evaluation of lumbar articular mobility by the schober index, coxofemoral by hip goniometry in flexion and extension (no evaluation of other amplitudes because lack of abduction / abduction / external and internal rotation of the hip remain functional in walking and the balance)
- Conditions
- Joint(S) Degeneration, Old Age; Atrophy, Fear of Injury
- Being tested
- anthropomorphic measurements
- Medical subject headings
- Joint Diseases, Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anthropomorphic measurementsDiagnostic test
Also called FES questionnaire
anthropomorphic measurements + FES questionnaire + demographic data and medications
What is being measured
The primary outcome is the main question the study is designed to answer.
Association FES and goniometry
Highlight a significant positive association between hips' goniometry (angle degree) and FES-I score (continuous scale without unit)
Measured: 15 minutes
Association FES-I (continuous scale without unit) and Schober index (centimeter)
Highlight a significant positive association between Shober index and FES-I score
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start1 Dec 2021
- Primary completion1 May 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Joint(S) DegenerationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital of Melun
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastien Jochmans, MD, Groupe Hospitalier Sud Ile-de-France
- Investigators
- SEBASTIEN JOCHMANS, M.D., Study director, GHSIF MELUN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05134038
- Sponsor's protocol ID
- 294-URC-GHSIF
- Acronym
- RAAPC
- Status last verified
- Sep 2024
- First submitted
- 23 Oct 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tinetti ME, Powell L. Fear of falling and low self-efficacy: a case of dependence in elderly persons. J Gerontol. 1993 Sep;48 Spec No:35-8. doi: 10.1093/geronj/48.special_issue.35. No abstract available.
PubMed 8409238Kendrick D, Kumar A, Carpenter H, Zijlstra GA, Skelton DA, Cook JR, Stevens Z, Belcher CM, Haworth D, Gawler SJ, Gage H, Masud T, Bowling A, Pearl M, Morris RW, Iliffe S, Delbaere K. Exercise for reducing fear of falling in older people living in the community. Cochrane Database Syst Rev. 2014 Nov 28;2014(11):CD009848. doi: 10.1002/14651858.CD009848.pub2.
PubMed 25432016Delbaere K, Close JC, Mikolaizak AS, Sachdev PS, Brodaty H, Lord SR. The Falls Efficacy Scale International (FES-I). A comprehensive longitudinal validation study. Age Ageing. 2010 Mar;39(2):210-6. doi: 10.1093/ageing/afp225. Epub 2010 Jan 8.
PubMed 20061508Laizeau C, Jochmans S, Aufaure S. Pelvic joint stiffness and fear of falling in patients over 75 years of age: a prospective cohort study of 100 patients. J Osteopath Med. 2024 May 8;124(11):481-486. doi: 10.1515/jom-2024-0004. eCollection 2024 Nov 1.
PubMed 38713850
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L'impact De La Raideur Articulaire Pelvienne Sur La Peur De Chuter Du Sujet Âgé Hospitalisé Ou En Institution.
- ClinicalTrials.gov ID
- NCT05134038
- Acronym / sponsor ID
- RAAPC / 294-URC-GHSIF
- Conditions
- Joint(S) Degeneration, Old Age; Atrophy, Fear of Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hopital of MelunUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 24 Nov 2021 (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.
- / evaluation of the fear of falling using an FES-I questionnaire, distribution of subjects according to the score into 3 groups (16-19: little concerned by the fear of falling, 20-27 moderately concerned, 28-64 very concerned by fear of falling)
- / evaluation of lumbar articular mobility by the schober index, coxofemoral by hip goniometry in flexion and extension (no evaluation of other amplitudes because lack of abduction / abduction / external and internal rotation of the hip remain functional in walking and the balance)
Detailed description
- / evaluation of the fear of falling using an FES-I questionnaire, distribution of subjects according to the score into 3 groups (16-19: little concerned by the fear of falling, 20-27 moderately concerned, 28-64 very concerned by fear of falling)
- / evaluation of lumbar articular mobility by the schober index, coxofemoral by hip goniometry in flexion and extension (no evaluation of other amplitudes because lack of abduction / abduction / external and internal rotation of the hip remain functional in walking and the balance)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- > 75 ans, in any geriatric department of the hospital
Key inclusion criteria (5 listed)
- over 75 years old,
- Ability to understand and answer a questionnaire in French
- Ability to stand up
- Patient from the Melun hospital (santé pole center + nursing home of the GHSIF)
- Affiliated with a social security scheme
Key exclusion criteria (2 listed)
- mental disorders,
- lumbar surgery
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 |
|---|---|---|
| anthropomorphic measurementsAlso: FES questionnaireanthropomorphic measurements + FES questionnaire + demographic data and medications | Diagnostic test | – |
Primary outcome
Association FES and goniometry
Time frame: 15 minutes
Highlight a significant positive association between hips' goniometry (angle degree) and FES-I score (continuous scale without unit)
Association FES-I (continuous scale without unit) and Schober index (centimeter)
Time frame: 15 minutes
Highlight a significant positive association between Shober index and FES-I score
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 19 Sep 2024.
- Background: PubMed 8409238Tinetti ME, Powell L. Fear of falling and low self-efficacy: a case of dependence in elderly persons. J Gerontol. 1993 Sep;48 Spec No:35-8. doi: 10.1093/geronj/48.special_issue.35. No abstract available.
- Background: PubMed 25432016Kendrick D, Kumar A, Carpenter H, Zijlstra GA, Skelton DA, Cook JR, Stevens Z, Belcher CM, Haworth D, Gawler SJ, Gage H, Masud T, Bowling A, Pearl M, Morris RW, Iliffe S, Delbaere K. Exercise for reducing fear of falling in older people living in the community. Cochrane Database Syst Rev. 2014 Nov 28;2014(11):CD009848. doi: 10.1002/14651858.CD009848.pub2.
- Background: PubMed 20061508Delbaere K, Close JC, Mikolaizak AS, Sachdev PS, Brodaty H, Lord SR. The Falls Efficacy Scale International (FES-I). A comprehensive longitudinal validation study. Age Ageing. 2010 Mar;39(2):210-6. doi: 10.1093/ageing/afp225. Epub 2010 Jan 8.
- Derived from this study: PubMed 38713850Laizeau C, Jochmans S, Aufaure S. Pelvic joint stiffness and fear of falling in patients over 75 years of age: a prospective cohort study of 100 patients. J Osteopath Med. 2024 May 8;124(11):481-486. doi: 10.1515/jom-2024-0004. eCollection 2024 Nov 1.
- 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.
SEBASTIEN JOCHMANS, M.D. study director
GHSIF MELUN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Joint(S) Degeneration and Old Age; Atrophy, run by Hopital of Melun at 1 site 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 5 inclusion and 2 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 19 Sep 2024. 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 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?
Association FES and goniometry (time frame: 15 minutes). 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?
On the ClinicalTrials.gov record for NCT05134038, which also lists 4 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 19 Sep 2024.