Assessment of MotivityNCT01706757
Assessment of Motivity in People Aged 65 to 86 Years
A study testing go-cart in people with Assessment of Motivity, run by Department of Clinical Research and Innovation at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 86 yearsHealthy volunteers can take part
- Conditions the study is for
- Assessment of Motivity
- What is being tested?
- go-cart
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 86 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- impossibility of carrying out the experimental protocol because of a mobility impairment
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Mémoire de Ressources et de Recherche
Nice, 06000
Julie Piano, Psychologue, 33 (0)4 92 03 47 75, piano/j@chu-nice.fr
Philippe Robert, MD, PhD, 33 (0)4 92 03 47 70, robert.p@chu-nice.fr
About this study
Official title: 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.
- Conditions
- Assessment of Motivity
- Being tested
- go-cart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
go-cartDevice
conducts exercises with the help of a go-cart
| Study group | Role | What they receive |
|---|---|---|
| with go-cart | Experimental | conducts exercises with the help of a go-cart Receives: Device: go-cart |
| without go-cart | No intervention | conduct exercises without go-cart |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one day
Secondary outcomes (1)
acceptance of the go-cart
- 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.
- 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
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assessment of MotivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Department of Clinical Research and Innovation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Department of Clinical Research and Innovation, Centre Hospitalier Universitaire de Nice
- Investigators
- Philippe Robert, Md, PhD, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01706757
- Sponsor's protocol ID
- 11-PP-05
- Status last verified
- Jul 2012
- First submitted
- 18 Jun 2012
- Last updated
- 15 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Motivity in People Aged 65 to 86 Years : Comparison of a Standard Assessment Versus a Technological Solution
- ClinicalTrials.gov ID
- NCT01706757
- Acronym / sponsor ID
- 11-PP-05
- Conditions
- Assessment of Motivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Department of Clinical Research and InnovationUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 15 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with go-cart | Experimental | Device: go-cartconducts exercises with the help of a go-cart |
| without go-cart | No intervention | –conduct exercises without go-cart |
Who may qualify
- Ages
- 65 to 86 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- impossibility of carrying out the experimental protocol because of a mobility impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| go-cartconducts exercises with the help of a go-cart | Device | with go-cart |
Primary outcome
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.
1 secondary outcome
acceptance of the go-cart
Time frame: one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Robert, Md, PhD principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing go-cart in people with Assessment of Motivity, run by Department of Clinical Research and Innovation at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie Piano, Psychologue (33 (0)4 92 03 47 75, piano.j@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking speed. (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2012.