Assessment of Motivity in People Aged 65 to 86 Years

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Assessment of Motivity	Device: go-cart	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	30 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Assessment of Motivity in People Aged 65 to 86 Years : Comparison of a Standard Assessment Versus a Technological Solution
Study Start Date :	December 2011
Estimated Primary Completion Date :	December 2012
Estimated Study Completion Date :	December 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: with go-cart; conducts exercises with the help of a go-cart	Device: go-cart; conducts exercises with the help of a go-cart
No Intervention: without go-cart; conduct exercises without go-cart

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. acceptance of the go-cart [ Time Frame: one day ]
   1. to assess the acceptance of ANG in the elderly. A questionnaire after the experiment will determine the level of acceptance of the go-cart, and to assess its ease of use.
   2. Develop mathematical algorithms to index certain characteristics of the market depending on the linear trajectory, U-turns. c) The detection of a weak joint. d) The index of walking on a path set will be made with and without use of the go-cart. e) Evaluate the ability of subjects to perform complex and precise trajectories

Eligibility Criteria

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Ages Eligible for Study:	65 Years to 86 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Julie Piano, Psychologue	33 (0)4 92 03 47 75	piano.j@chu-nice.fr

Locations

France
Centre Mémoire de Ressources et de Recherche	Recruiting
Nice, France, 06000
Contact: Julie Piano, Psychologue 33 (0)4 92 03 47 75 piano/j@chu-nice.fr
Contact: Philippe Robert, MD, PhD 33 (0)4 92 03 47 70 robert.p@chu-nice.fr
Principal Investigator: Philippe Robert, MD, PhD

Sponsors and Collaborators

Department of Clinical Research and Innovation

Investigators

Principal Investigator:	Philippe Robert, Md, PhD	CHU de Nice

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Department of Clinical Research and Innovation, Department of Clinical Research and Innovation (drc), Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:	NCT01706757 History of Changes
Other Study ID Numbers:	11-PP-05
First Posted:	October 15, 2012
Last Update Posted:	October 15, 2012
Last Verified:	July 2012