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

Not Applicable

• Conditions: Fall Patients
• Interventions: Behavioral: training with Cycléo device (COTTOS ®),; Other: non intervention

• Registration Number: NCT05422495
• Lead Sponsor: University Hospital, Caen

Brief 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. 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

Not available

Study Timeline

• Study Start: 2021-01-26
• Status Verified: 2022-06
• Study First Submitted: 2022-06-10
• Study First Submitted QC: 2022-06-14
• Last Update Submitted: 2022-06-14
• Study First Posted: 2022-06-16
• Last Update Posted: 2022-06-16
• Primary Completion: 2023-01-26
• Study Completion: 2024-01-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Activity	training with Cycléo device (COTTOS ®),	cognitive-motor training : Cycléo device (COTTOS ®),
No activity	non intervention	no training

Primary Outcome Measures

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

Trial Locations

Locations (1)

Caen University Hospital; 🇫🇷 Caen, France