Contribution of Actigraphy for the Evaluation of Elbow Range of Motion in the Joint Assessment in Gerontology (BIOVAL)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Geriatric Disorder |
Device: Assessment with inclinometer Device: Assessment with actigraph |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Contribution of Actigraphy for the Evaluation of Elbow Range of Motion in the Joint Assessment in Gerontology |
- Inclinometer and actigraph assessment [ Time Frame: elbow joint measures are done just at one time point, during the visit ] [ Designated as safety issue: No ]Elbow joint measures by the inclinometer and the actigraph
- Assessment of easily use [ Time Frame: Assessment are done just at one time point, during the visit ] [ Designated as safety issue: No ]Assessment of easily use
- Assessment comfort and utility of use [ Time Frame: Assessment are done just at one time point, during the visit ] [ Designated as safety issue: No ]Assessment of comfort and utility of use
- measurement time [ Time Frame: Assessment are done just at one time point, during the visit ] [ Designated as safety issue: No ]measurement time
| Estimated Enrollment: | 85 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
First assessment: inclinometer
First assessment: inclinometer Second assessment: actigraph and inclinometer
|
Device: Assessment with inclinometer
joint assessment with inclinometer. The inclinometer used in this trial is Baseline® Bubble Inclinometer
|
|
first: Inclinometer and actigraph
first: Inclinometer and actigraph second: inclinometer
|
Device: Assessment with inclinometer
joint assessment with inclinometer. The inclinometer used in this trial is Baseline® Bubble Inclinometer
Device: Assessment with actigraph
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.
|
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
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Prescription of physiotherapy .
- Prescription of a passive joint assessment
- Consent to participate in the study signed
- person with a social security system
Exclusion Criteria:
- 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
Contacts and Locations| Contact: Philippe ROBERT, PhD | robert.p@chu-nice.fr |
| France | |
| Centre Memoire Ressources et Recherche, CHU de Nice | Recruiting |
| Nice, France, 06000 | |
| Contact: Delphine DEL CONT delcont.d@chu-nice.fr | |
| Principal Investigator: Philippe ROBERT, PhD | |
| Sub-Investigator: Jean-Michel TURPIN, PhD | |
| Principal Investigator: | Philippe ROBERT, PhD | CHU de NICE |
More Information
No publications provided
| Responsible Party: | Del Cont Delphine, Professeur, Centre Hospitalier Universitaire de Nice |
| ClinicalTrials.gov Identifier: | NCT01462760 History of Changes |
| Other Study ID Numbers: | 11-PP-11 |
| Study First Received: | October 12, 2011 |
| Last Updated: | October 27, 2011 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: Committee for the Protection of Personnes France: French Data Protection Authority |
ClinicalTrials.gov processed this record on May 23, 2013