Contribution of Actigraphy for the Evaluation of Elbow Range of Motion in the Joint Assessment in Gerontology

Geriatric Disorder Clinical Trial

— BIOVAL  

Official title:

Contribution of Actigraphy for the Evaluation of Elbow Range of Motion in the Joint Assessment in Gerontology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01462760
• Other study ID #: 11-PP-11
• Status: Recruiting
• Phase: N/A
• First received: October 12, 2011
• Last updated: October 27, 2011
• Start date: October 2011
• Est. completion date: August 2012

Study information

• Verified date: October 2011
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Philippe ROBERT, PhD
• Email: robert.p[@]chu-nice.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of PersonnesFrance: French Data Protection Authority
• Study type: Interventional

Clinical 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). It will also be evaluated during this study, the ease of use and feedback.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 85
• Est. completion date: August 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Geriatric Disorder

Intervention

Device:
• Assessment with inclinometer
joint assessment with inclinometer. The inclinometer used in this trial is Baseline® Bubble Inclinometer
• 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.

Locations

Country	Name	City	State
France	Centre Memoire Ressources et Recherche, CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inclinometer and actigraph assessment	Elbow joint measures by the inclinometer and the actigraph	elbow joint measures are done just at one time point, during the visit	No
Secondary	Assessment of easily use	Assessment of easily use	Assessment are done just at one time point, during the visit	No
Secondary	Assessment comfort and utility of use	Assessment of comfort and utility of use	Assessment are done just at one time point, during the visit	No
Secondary	measurement time	measurement time	Assessment are done just at one time point, during the visit	No