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

June 14, 2022 updated by: University Hospital, Caen

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France
        • Recruiting
        • Caen University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Activity
cognitive-motor training : Cycléo device (COTTOS ®),
Behavioral: training with Cycléo device (COTTOS ®),
8 weeks of training
Placebo Comparator: No activity
no training
Other: non intervention
non intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Timed Up and Go (TUG)
Time Frame: change between baseline and 6 month
change between baseline and 6 month
MMSE globale cognitive assesment
Time Frame: change between baseline and 6 month
change between baseline and 6 month
Attention assessed by WAIS digit spans
Time Frame: change between baseline and 6 month
change between baseline and 6 month
Executive functions assessed by the TMT A AND B
Time Frame: change between baseline and 6 month
change between baseline and 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2021

Primary Completion (Anticipated)

January 26, 2023

Study Completion (Anticipated)

January 26, 2024

Study Registration Dates

First Submitted

June 10, 2022

First Submitted That Met QC Criteria

June 14, 2022

First Posted (Actual)

June 16, 2022

Study Record Updates

Last Update Posted (Actual)

June 16, 2022

Last Update Submitted That Met QC Criteria

June 14, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 19-214

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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