Fall PatientsGATENCT05422495
Effect of Playful Cognitive-motor Mobility Training on Balance, Gait and Cognition and on the Prevention of Falls in Seniors
A study testing training with Cycléo device (COTTOS ®), and non intervention in people with Fall Patients, run by University Hospital, Caen at 1 site in France.
Trial summary
Falls in the elderly are the cause of considerable morbidity and mortality and constitute a public health problem with more than 9000 deaths in France among the over 65s following an accidental fall. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Fall Patients
- What is being tested?
- training with Cycléo device (COTTOS ®), and non intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jan 2021to 26 Jan 2024
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged over 60, residing in nursing homes
- Subjects able to walk 15 meters unaided
- MMSE > 10
- Visual acuity in both eyes > 6/10
- Affiliated subject or beneficiary of a social security scheme
- Subject having given and signed an informed consent to participate in the study, or his/her guardian
- Subject having a sedentary activity or practicing a usual light to moderate physical activity (physical activities < 6 METs)
Who cannot join
- Subject with a parkinsonian syndrome, any impairment of the motor neuron, pain limiting the practice of physical activity
- Subject with a modification of less than 3 months of psychotropic drugs
- Subject practicing high intensity physical activity (> 6 METs)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Caen University Hospital
Caen
Loggia Gilles, 0230063106 ext. +33, loggia-g@chu-caen.fr
About this study
Falls in the elderly are the cause of considerable morbidity and mortality and constitute a public health problem with more than 9000 deaths in France among the over 65s following an accidental fall. Many scientific data suggest that regular physical activity has significant and long-lasting beneficial effects on the health of the elderly and is associated with better functional status, a lower risk of falls and improved cognitive functions. However, the attraction to physical activity fades over the years and the reasons mentioned by the elderly for a low practice of physical activity are multiple, the main one being the worsening of their state of health.
The objective of this study is therefore to evaluate the impact of playful, motivating mobility training, stimulating both mobility and cognition, for 8 weeks, on the balance and mobility of elderly people in EHPAD, in particular in conditions of dual-task well known to be at high risk of falling, as well as on the prevention of falls.
- Conditions
- Fall Patients
- Being tested
- training with Cycléo device (COTTOS ®),, non intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
training with Cycléo device (COTTOS ®),Behavioural
8 weeks of training
non interventionOther
non intervention
| Study group | Role | What they receive |
|---|---|---|
| Activity | Experimental | cognitive-motor training : Cycléo device (COTTOS ®), Receives: Behavioral: training with Cycléo device (COTTOS ®), |
| No activity | Placebo comparator | no training Receives: Other: non intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go (TUG)
Measured: change between baseline and 6 month
MMSE globale cognitive assesment
Measured: change between baseline and 6 month
Attention assessed by WAIS digit spans
Measured: change between baseline and 6 month
Executive functions assessed by the TMT A AND B
Measured: change between baseline and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start26 Jan 2021
- Primary completion26 Jan 2023 (estimated)
- Study completion26 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall PatientsStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422495
- Sponsor's protocol ID
- 19-214
- Acronym
- GATE
- Status last verified
- Jun 2022
- First submitted
- 10 Jun 2022
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Playful Cognitive-motor Mobility Training on Balance, Gait and Cognition and on the Prevention of Falls in Seniors
- ClinicalTrials.gov ID
- NCT05422495
- Acronym / sponsor ID
- GATE / 19-214
- Conditions
- Fall Patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 26 Jan 2023 (estimated)
- Study completion
- 26 Jan 2024 (estimated)
- First posted
- 16 Jun 2022 (actual)
- 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.
Falls in the elderly are the cause of considerable morbidity and mortality and constitute a public health problem with more than 9000 deaths in France among the over 65s following an accidental fall. Many scientific data suggest that regular physical activity has significant and long-lasting beneficial effects on the health of the elderly and is associated with better functional status, a lower risk of falls and improved cognitive functions. However, the attraction to physical activity fades over the years and the reasons mentioned by the elderly for a low practice of physical activity are multiple, the main one being the worsening of their state of health.
The objective of this study is therefore to evaluate the impact of playful, motivating mobility training, stimulating both mobility and cognition, for 8 weeks, on the balance and mobility of elderly people in EHPAD, in particular in conditions of dual-task well known to be at high risk of falling, as well as on the prevention of falls.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Activity | Experimental | Behavioral: training with Cycléo device (COTTOS ®),cognitive-motor training : Cycléo device (COTTOS ®), |
| No activity | Placebo comparator | Other: non interventionno training |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects aged over 60, residing in nursing homes
- Subjects able to walk 15 meters unaided
- MMSE > 10
- Visual acuity in both eyes > 6/10
- Affiliated subject or beneficiary of a social security scheme
Key exclusion criteria (3 listed)
- Subject with a parkinsonian syndrome, any impairment of the motor neuron, pain limiting the practice of physical activity
- Subject with a modification of less than 3 months of psychotropic drugs
- Subject practicing high intensity physical activity (> 6 METs)
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 |
|---|---|---|
| training with Cycléo device (COTTOS ®),8 weeks of training | Behavioural | Activity |
| non interventionnon intervention | Other | No activity |
Primary outcome
Timed Up and Go (TUG)
Time frame: change between baseline and 6 month
MMSE globale cognitive assesment
Time frame: change between baseline and 6 month
Attention assessed by WAIS digit spans
Time frame: change between baseline and 6 month
Executive functions assessed by the TMT A AND B
Time frame: change between baseline and 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing training with Cycléo device (COTTOS ®), and non intervention in people with Fall Patients, run by University Hospital, Caen 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 7 inclusion and 3 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 16 Jun 2022. 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. Some participants in this study may receive a placebo. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go (TUG) (time frame: change between baseline and 6 month). The study lists 4 primary outcomes in all. 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 16 Jun 2022.