Geriatric DisorderBIOVALNCT01462760
Contribution of Actigraphy for the Evaluation of Elbow Range of Motion in the Joint Assessment in Gerontology
A study testing Assessment with inclinometer and Assessment with actigraph in people with Geriatric Disorder, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
In this study, the investigators will measure range of motion of the elbow in a geriatric assessment in 85 subjects aged 65 years or over. These measures will be made by an actigraph and the software analysis BioVal. This technique will be compared with the standard technique (inclinometer). Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Geriatric Disorder
- What is being tested?
- Assessment with inclinometer and Assessment with actigraph
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2011to Aug 2012
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Prescription of physiotherapy .
- Prescription of a passive joint assessment
- Consent to participate in the study signed
- person with a social security system
Who cannot join
- person with a pacemeker
- patient with the inability to position the wrist straightness
- patient with the inability to position the shoulder in neutral
- metal prosthesis or osteosynthesis
- patient with a joint debate <20 °
- contraindicated warm up
Trial locations and contacts
1 site in 1 country.
Philippe ROBERT, PhD contact
France1 site, 1 recruiting
- Recruiting
Centre Memoire Ressources et Recherche, CHU de Nice
Nice, 06000
Delphine DEL CONT, delcont.d@chu-nice.fr
Philippe ROBERT, PhD
About this study
In this study, the investigators will measure range of motion of the elbow in a geriatric assessment in 85 subjects aged 65 years or over. These measures will be made by an actigraph and the software analysis BioVal. This technique will be compared with the standard technique (inclinometer). It will also be evaluated during this study, the ease of use and feedback.
Read the detailed description
The deterioration of the musculoskeletal system occurring in aging is a major cause of loss of autonomy and directly affects the quality of life of the individual.
Support and appropriate rehabilitation for the patient's return home is essential. It requires physiotherapy assessment, which includes, among other things, a joint assessment with a measure passive range of motion.
Physical therapists have different techniques to achieve these measures for each of them, the benefits (time, reliability) and disadvantages. Among them, the goniometer and inclinometer are technical references The main objective of the study is to validate the MotionPod and the software BioVal as valid tool for measuring range of motion of the elbow in a joint geriatric assessment.
Secondary objectives are the study of the reproducibility of the measurement time and ease of use The measurement range of motion in the elbow in degree, estimated by actigraphy and software BioVal will be compared to those obtained with an inclinometer.
The movements are examined successively flexion, extension, pronation and supination.
The proportion of valid measurements will be calculated for each movement. The confidence interval 95% partner will also be calculated.
Moreover, in order to judge the validity of actigraphy in all of these measures, the investigators will calculate the proportion of patients for which the measures are valid for all four movements and the confidence interval 95% partner.
85 patients aged 65 years or more will be recruited at the Cimiez hospital the CHU of Nice, in the services of short, medium and long geriatric stay
- Conditions
- Geriatric Disorder
- Being tested
- Assessment with inclinometer, Assessment with actigraph
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment with inclinometerDevice
joint assessment with inclinometer. The inclinometer used in this trial is Baseline® Bubble Inclinometer
Assessment with actigraphDevice
joint assessment with actigraph The actigraph used in this trial is the Motion Pod. It's an analysis and reeducation systems by biofeedback. The manufacturer is Movea.
| Study group | Role | What they receive |
|---|---|---|
| First assessment: inclinometer | Other | First assessment: inclinometer Second assessment: actigraph and inclinometer Receives: Device: Assessment with inclinometer |
| first: Inclinometer and actigraph | Other | first: Inclinometer and actigraph second: inclinometer Receives: Device: Assessment with inclinometer; Device: Assessment with actigraph |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inclinometer and actigraph assessment
Elbow joint measures by the inclinometer and the actigraph
Measured: elbow joint measures are done just at one time point, during the visit
Secondary outcomes (3)
Assessment of easily use
Assessment of easily use
Measured: Assessment are done just at one time point, during the visit
Assessment comfort and utility of use
Assessment of comfort and utility of use
Measured: Assessment are done just at one time point, during the visit
measurement time
measurement time
Measured: Assessment are done just at one time point, during the visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionMay 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Geriatric DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Del Cont Delphine, Centre Hospitalier Universitaire de Nice
- Investigators
- Philippe ROBERT, PhD, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01462760
- Sponsor's protocol ID
- 11-PP-11
- Acronym
- BIOVAL
- Status last verified
- Oct 2011
- First submitted
- 12 Oct 2011
- Last updated
- 31 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Sacco G, Turpin JM, Marteu A, Sakarovitch C, Teboul B, Boscher L, Brocker P, Robert P, Guerin O. Inertial sensors as measurement tools of elbow range of motion in gerontology. Clin Interv Aging. 2015 Feb 23;10:491-7. doi: 10.2147/CIA.S70452. eCollection 2015.
PubMed 25759568
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Actigraphy for the Evaluation of Elbow Range of Motion in the Joint Assessment in Gerontology
- ClinicalTrials.gov ID
- NCT01462760
- Acronym / sponsor ID
- BIOVAL / 11-PP-11
- Conditions
- Geriatric Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- May 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 31 Oct 2011 (estimated)
- 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.
In this study, the investigators will measure range of motion of the elbow in a geriatric assessment in 85 subjects aged 65 years or over. These measures will be made by an actigraph and the software analysis BioVal. This technique will be compared with the standard technique (inclinometer). It will also be evaluated during this study, the ease of use and feedback.
Detailed description
The deterioration of the musculoskeletal system occurring in aging is a major cause of loss of autonomy and directly affects the quality of life of the individual.
Support and appropriate rehabilitation for the patient's return home is essential. It requires physiotherapy assessment, which includes, among other things, a joint assessment with a measure passive range of motion.
Physical therapists have different techniques to achieve these measures for each of them, the benefits (time, reliability) and disadvantages. Among them, the goniometer and inclinometer are technical references The main objective of the study is to validate the MotionPod and the software BioVal as valid tool for measuring range of motion of the elbow in a joint geriatric assessment.
Secondary objectives are the study of the reproducibility of the measurement time and ease of use The measurement range of motion in the elbow in degree, estimated by actigraphy and software BioVal will be compared to those obtained with an inclinometer.
The movements are examined successively flexion, extension, pronation and supination.
The proportion of valid measurements will be calculated for each movement. The confidence interval 95% partner will also be calculated.
Moreover, in order to judge the validity of actigraphy in all of these measures, the investigators will calculate the proportion of patients for which the measures are valid for all four movements and the confidence interval 95% partner.
85 patients aged 65 years or more will be recruited at the Cimiez hospital the CHU of Nice, in the services of short, medium and long geriatric stay
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First assessment: inclinometer | Other | Device: Assessment with inclinometerFirst assessment: inclinometer Second assessment: actigraph and inclinometer |
| first: Inclinometer and actigraph | Other | Device: Assessment with inclinometer, Device: Assessment with actigraphfirst: Inclinometer and actigraph second: inclinometer |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Prescription of physiotherapy .
- Prescription of a passive joint assessment
- Consent to participate in the study signed
- person with a social security system
Key exclusion criteria (6 listed)
- person with a pacemeker
- patient with the inability to position the wrist straightness
- patient with the inability to position the shoulder in neutral
- metal prosthesis or osteosynthesis
- patient with a joint debate <20 °
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 with inclinometerjoint assessment with inclinometer. The inclinometer used in this trial is Baseline® Bubble Inclinometer | Device | First assessment: inclinometer, first: Inclinometer and actigraph |
| Assessment with actigraphjoint assessment with actigraph The actigraph used in this trial is the Motion Pod. It's an analysis and reeducation systems by biofeedback. The manufacturer is Movea. | Device | first: Inclinometer and actigraph |
Primary outcome
Inclinometer and actigraph assessment
Time frame: elbow joint measures are done just at one time point, during the visit
Elbow joint measures by the inclinometer and the actigraph
3 secondary outcomes
Assessment of easily use
Time frame: Assessment are done just at one time point, during the visit
Assessment comfort and utility of use
Time frame: Assessment are done just at one time point, during the visit
measurement time
Time frame: Assessment are done just at one time point, during the visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2011.
- Derived from this study: PubMed 25759568Sacco G, Turpin JM, Marteu A, Sakarovitch C, Teboul B, Boscher L, Brocker P, Robert P, Guerin O. Inertial sensors as measurement tools of elbow range of motion in gerontology. Clin Interv Aging. 2015 Feb 23;10:491-7. doi: 10.2147/CIA.S70452. eCollection 2015.
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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.
Philippe ROBERT, PhD contact
Philippe ROBERT, PhD principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment with inclinometer and Assessment with actigraph in people with Geriatric Disorder, run by Centre Hospitalier Universitaire de Nice 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 31 Oct 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe ROBERT, PhD (robert.p@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inclinometer and actigraph assessment (time frame: elbow joint measures are done just at one time point, during the visit). 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 NCT01462760, which also lists 1 linked publication.
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 31 Oct 2011.