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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2011 by Del Cont Delphine, Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01462760
First Posted: October 31, 2011
Last Update Posted: October 31, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Del Cont Delphine, Centre Hospitalier Universitaire de Nice
October 12, 2011
October 31, 2011
October 31, 2011
October 2011
May 2012   (Final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
  • Assessment of easily use [ Time Frame: Assessment are done just at one time point, during the visit ]
    Assessment of easily use
  • Assessment comfort and utility of use [ Time Frame: Assessment are done just at one time point, during the visit ]
    Assessment of comfort and utility of use
  • measurement time [ Time Frame: Assessment are done just at one time point, during the visit ]
    measurement time
Same as current
Not Provided
Not Provided
 
Contribution of Actigraphy for the Evaluation of Elbow Range of Motion in the Joint Assessment in Gerontology
Contribution of Actigraphy for the Evaluation of Elbow Range of Motion in the Joint Assessment in Gerontology
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.

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

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Geriatric Disorder
  • 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.
  • First assessment: inclinometer
    First assessment: inclinometer Second assessment: actigraph and inclinometer
    Intervention: Device: Assessment with inclinometer
  • first: Inclinometer and actigraph
    first: Inclinometer and actigraph second: inclinometer
    Interventions:
    • Device: Assessment with inclinometer
    • Device: Assessment with actigraph
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
85
August 2012
May 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
65 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01462760
11-PP-11
No
Not Provided
Not Provided
Del Cont Delphine, Centre Hospitalier Universitaire de Nice
Centre Hospitalier Universitaire de Nice
Not Provided
Principal Investigator: Philippe ROBERT, PhD CHU de NICE
Centre Hospitalier Universitaire de Nice
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP