Assessment of Motivity in People Aged 65 to 86 Years

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Centre Hospitalier Universitaire de Nice.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Department of Clinical Research and Innovation, Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01706757
First received: June 18, 2012
Last updated: October 12, 2012
Last verified: July 2012
  Purpose

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 Intervention
Assessment of Motivity
Device: go-cart

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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

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

Primary Outcome Measures:
  • Walking speed. [ Time Frame: one day ] [ Designated as safety issue: No ]

    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:
  • acceptance of the go-cart [ Time Frame: one day ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 30
Study Start Date: December 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   65 Years to 86 Years
Genders Eligible for Study:   Both
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
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: NCT01706757

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

No publications provided

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
Study First Received: June 18, 2012
Last Updated: October 12, 2012
Health Authority: France: Committee for the Protection of Personnes
France: The Commission nationale de l’informatique et des libertés

ClinicalTrials.gov processed this record on August 20, 2014