Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 12:45 AM
Study NCT ID:
NCT01462760
Status:
UNKNOWN
Last Update Posted:
2011-10-31
First Post:
2011-10-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Contribution of Actigraphy for the Evaluation of Elbow Range of Motion in the Joint Assessment in Gerontology
Sponsor:
Centre Hospitalier Universitaire de Nice
Organization:
Study Overview
Official Title:
Contribution of Actigraphy for the Evaluation of Elbow Range of Motion in the Joint Assessment in Gerontology
Status:
UNKNOWN
Status Verified Date:
2011-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIOVAL
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.
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: