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

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.

Study Overview

• Status: Unknown
• Conditions: Geriatric Disorder
• Intervention / Treatment: Device: Assessment with inclinometer; Device: Assessment with actigraph

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 Type: Interventional
• Enrollment (Anticipated): 85
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Philippe ROBERT, PhD; Email: robert.p@chu-nice.fr

Study Locations

• France
  • Nice, France, 06000
    • Recruiting
    • Centre Memoire Ressources et Recherche, CHU de Nice
    • Sub-Investigator: Jean-Michel TURPIN, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of easily use	Assessment of easily use	Assessment are done just at one time point, during the visit
Assessment comfort and utility of use	Assessment of comfort and utility of use	Assessment are done just at one time point, during the visit
measurement time	measurement time	Assessment are done just at one time point, during the visit

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Philippe ROBERT, PhD, Centre Hospitalier Universitaire de Nice

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (ANTICIPATED): May 1, 2012
• Study Completion (ANTICIPATED): August 1, 2012

Study Registration Dates

• First Submitted: October 12, 2011
• First Submitted That Met QC Criteria: October 27, 2011
• First Posted (ESTIMATE): October 31, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): October 31, 2011
• Last Update Submitted That Met QC Criteria: October 27, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: 11-PP-11