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 because the information has not been verified recently.
Verified October 2011 by Centre Hospitalier Universitaire de Nice.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Del Cont Delphine, Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01462760
First received: October 12, 2011
Last updated: October 27, 2011
Last verified: October 2011
  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

Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01462760

Contacts
Contact: Philippe ROBERT, PhD robert.p@chu-nice.fr

Locations
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         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
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 October 22, 2014