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

C

Caen University Hospital

Status

Enrolling

Conditions

Fall Patients

Treatments

Other: non intervention
Behavioral: training with Cycléo device (COTTOS ®),

Study type

Interventional

Funder types

Other

Identifiers

NCT05422495
19-214

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups, including a placebo group

Activity
Experimental group
Description:
cognitive-motor training : Cycléo device (COTTOS ®),
Treatment:
Behavioral: training with Cycléo device (COTTOS ®),
No activity
Placebo Comparator group
Description:
no training
Treatment:
Other: non intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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