NCT01706757

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.

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2011

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 15, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

October 15, 2012

Status Verified

July 1, 2012

Enrollment Period

1 year

First QC Date

June 18, 2012

Last Update Submit

October 12, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Walking speed.

    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 Outcomes (1)

  • acceptance of the go-cart

    one day

Study Arms (2)

with go-cart

EXPERIMENTAL

conducts exercises with the help of a go-cart

Device: go-cart

without go-cart

NO INTERVENTION

conduct exercises without go-cart

Interventions

go-cartDEVICE

conducts exercises with the help of a go-cart

with go-cart

Eligibility Criteria

Age65 Years - 86 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • impossibility of carrying out the experimental protocol because of a mobility impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Mémoire de Ressources et de Recherche

Nice, 06000, France

RECRUITING

Study Officials

  • Philippe Robert, Md, PhD

    Centre Hospitalier Universitaire de Nice

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Piano, Psychologue

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Department of Clinical Research and Innovation (drc)

Study Record Dates

First Submitted

June 18, 2012

First Posted

October 15, 2012

Study Start

December 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

October 15, 2012

Record last verified: 2012-07

Locations