NCT01462760

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2011

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 31, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

October 31, 2011

Status Verified

October 1, 2011

Enrollment Period

7 months

First QC Date

October 12, 2011

Last Update Submit

October 27, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Assessment of easily use

    Assessment are done just at one time point, during the visit

  • Assessment comfort and utility of use

    Assessment are done just at one time point, during the visit

  • measurement time

    Assessment are done just at one time point, during the visit

Study Arms (2)

First assessment: inclinometer

OTHER

First assessment: inclinometer Second assessment: actigraph and inclinometer

Device: Assessment with inclinometer

first: Inclinometer and actigraph

OTHER

first: Inclinometer and actigraph second: inclinometer

Device: Assessment with inclinometerDevice: Assessment with actigraph

Interventions

joint assessment with inclinometer. The inclinometer used in this trial is Baseline® Bubble Inclinometer

First assessment: inclinometerfirst: Inclinometer and 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: Inclinometer and actigraph

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Prescription of physiotherapy .
  • Prescription of a passive joint assessment
  • Consent to participate in the study signed
  • person with a social security system

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Memoire Ressources et Recherche, CHU de Nice

Nice, 06000, France

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Physical Examination

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Philippe ROBERT, PhD

    Centre Hospitalier Universitaire de Nice

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe ROBERT, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professeur

Study Record Dates

First Submitted

October 12, 2011

First Posted

October 31, 2011

Study Start

October 1, 2011

Primary Completion

May 1, 2012

Study Completion

August 1, 2012

Last Updated

October 31, 2011

Record last verified: 2011-10

Locations