- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01706757
Assessment of Motivity in People Aged 65 to 86 Years
October 12, 2012 updated by: Department of Clinical Research and Innovation
Assessment of Motivity in People Aged 65 to 86 Years : Comparison of a Standard Assessment Versus a Technological Solution
The ability to walk is one of the fundamental attributes of human beings.
However, with advancing age this ability is modified by a combination of physiological and pathological aging.These changes mainly involve an irregularity of the pitch, reducing the length of the stride, instability and a decrease in walking speed (Beauchet et al., 2002).
Tinetti, Speecheley, Ginter (1988, from Ch Wider, F. Vingerhoets, J Bogousslavsky, 2005) show that 20-30% of heathly older fall each year and state that one of these falls, 25% result in injuries with significant effect and 5% a fracture.
In addition to the risk of fracture fear of falling exists in many older people even before a drop in effective (Recommandation of HAS, 2005).In France, about 9 000 deaths of people aged over 65 are associated each year with a fall and this association increases rapidly with advancing age in both sexes.
It is therefore important in terms of public health, learn to recognize the gait disturbance, to prevent and to make adequate assessments to reduce the risk of falls.
Tools exist to assess the risk of falling.
Some are comprehensive but time-consuming and are generally discarded in favour of other simpler tests (test of Tinetti or get up and go test).
However, the listing of these lacks precision, particularly in terms of duration single timer.To overcome these biases, innovative technology solutions seem to be a good way.
In this study, the investigators will use the motorized go-cart developed by INRIA, entitled ANG (for Assisted Navigation Guide), to obtain more reliable and accurate measurements of parameters such as walking speed and direction.
Thus, the investigators set the main objective, to compare a standard evaluation of the process to a technology assessment, in participants aged 65 to 86 years.
And as secondary objectives : evaluate the acceptance of using go-cart ANG in the elderly, develop an index of walking and test the feasibility of detecting a weakness of the knee joint by ANG undetected at clinic.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Nice, France, 06000
- Recruiting
- Centre Mémoire de Ressources et de Recherche
-
Contact:
- Julie Piano, Psychologue
- Phone Number: 33 (0)4 92 03 47 75
- Email: piano/j@chu-nice.fr
-
Contact:
- Philippe Robert, MD, PhD
- Phone Number: 33 (0)4 92 03 47 70
- Email: robert.p@chu-nice.fr
-
Principal Investigator:
- Philippe Robert, MD, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 86 years (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- men and women aged between 65 and 86 years
- participants with no locomotor disability hindering the implementation of the protocol
- participants with no global cognitive impairment (MMSE score <24) (Folstein et al. 1975), or arguments in favor of the following diagnoses : probable Alzheimer's disease according to the criteria of the NINCDS-ADRDA, major depressive episode according to DSM-IV-R
- participant with no apathy according to diagnostic criteria for apathy (Robert, Onyike et al. 2009)
- participants recipients of social security
- signature of informed consent.
Exclusion Criteria:
- impossibility of carrying out the experimental protocol because of a mobility impairment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: with go-cart
conducts exercises with the help of a go-cart
|
conducts exercises with the help of a go-cart
|
|
No Intervention: without go-cart
conduct exercises without go-cart
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Walking speed.
Time Frame: one day
|
Walking speed. This will be calculated from an exercise where participants will be asked to walk from one point to another of the room according to the instructions set out below. The average speed of walking in technology assessment, will be directly collected by ANG. A comparison of estimated speeds as standard and technology can then be performed. |
one day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
acceptance of the go-cart
Time Frame: one day
|
|
one day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Philippe Robert, Md, PhD, Centre Hospitalier Universitaire de Nice
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2011
Primary Completion (Anticipated)
December 1, 2012
Study Completion (Anticipated)
December 1, 2012
Study Registration Dates
First Submitted
June 18, 2012
First Submitted That Met QC Criteria
October 12, 2012
First Posted (Estimate)
October 15, 2012
Study Record Updates
Last Update Posted (Estimate)
October 15, 2012
Last Update Submitted That Met QC Criteria
October 12, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- 11-PP-05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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