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

Fall Patients Clinical Trial

— GATE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05422495
• Other study ID #: 19-214
• Status: Recruiting
• Phase: N/A
• Start date: January 26, 2021
• Est. completion date: January 26, 2024

Study information

• Verified date: June 2022
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 26, 2024
• Est. primary completion date: January 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Fall Patients

Intervention

Behavioral:
• training with Cycléo device (COTTOS ®),
8 weeks of training

Other:
• non intervention
non intervention

Locations

Country	Name	City	State
France	Caen University Hospital	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timed Up and Go (TUG)		change between baseline and 6 month
Primary	MMSE globale cognitive assesment		change between baseline and 6 month
Primary	Attention assessed by WAIS digit spans		change between baseline and 6 month
Primary	Executive functions assessed by the TMT A AND B		change between baseline and 6 month