Effect of Playful Cognitive-motor Mobility Training on Balance, Gait and Cognition and on the Prevention of Falls in Seniors

NCT ID: NCT05422495

Last Updated: 2022-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-26

Study Completion Date

2024-01-26

Brief Summary

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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.

Detailed Description

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Conditions

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Fall Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Activity

cognitive-motor training : Cycléo device (COTTOS ®),

Group Type EXPERIMENTAL

training with Cycléo device (COTTOS ®),

Intervention Type BEHAVIORAL

8 weeks of training

No activity

no training

Group Type PLACEBO_COMPARATOR

non intervention

Intervention Type OTHER

non intervention

Interventions

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training with Cycléo device (COTTOS ®),

8 weeks of training

Intervention Type BEHAVIORAL

non intervention

non intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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)
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Caen University Hospital

Caen, , France

Site Status RECRUITING

Countries

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France

Facility Contacts

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Loggia Gilles

Role: primary

0230063106 ext. +33

Other Identifiers

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19-214

Identifier Type: -

Identifier Source: org_study_id

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