NCT04103827

Brief Summary

Falls are a frequent and serious problem in old people. It is estimated that one-third of subjects over 65 years of age and 50% of those over 85 years of age have at least one fall per year (1). The traumatic and psychological consequences of falls contribute to the loss of functional independence and lead to early institutionalization (2). All activities of daily living require us to maintain a state of postural balance, whether standing, sitting, static or dynamic. Thus, good coordination is essential to maintain balance, reflecting both peripheral (muscular) and central (cognitive) motor control (3,4). Coordination skills between posture and movement decline during aging without associated disorder, and even more so when this aging is associated by cognitive disorders (5,6). On the contrary, as part of a balance rehabilitation program, an adapted training allows the partial recovery of the balance management process in elderly subjects who fall (7). Le Qoos® by LudHealth is technical foam equipment, which can be installed on the wall, to practice various physical exercises. It can therefore be used as a simple support, leaning on with hands, arms, feet or even the head, exerting contact points, pressures or even impacts with more or less force. Le Qoos® is an equipment that allows to perform, on the same object, gentle or tonic exercises, balance, flexibility, sheathing or muscle strengthening while having fun. We hypothesize that cognitive-physical stimulation workshops based on the use of the device Le Qoos® and is environment are i) adapted to geriatric fall prevention issues, ii) accessible to elderly hospitalized patients and health professionals, and iii) effective and safe to maintain and/or recover postural balance in elderly hospitalized patients. First step of this work is to assess whether "Le Qoos" is considered as usable par end-users of the device.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

September 16, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 25, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2020

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2020

Completed
Last Updated

February 24, 2020

Status Verified

February 1, 2020

Enrollment Period

1 year

First QC Date

September 13, 2019

Last Update Submit

February 20, 2020

Conditions

Keywords

UsabilityElderlyOld peoplePhysical activityBalance

Outcome Measures

Primary Outcomes (1)

  • Usability of the device "Le Qoos"

    The usability will be assessed using the validated System Usability Scale (SUS). SUS scale range from 0 to 100. The mean score obtained by users will be calculated. A score over 50 could be considered as acceptable usability. A score over 65 could be considered as good usability.

    During the 48 hours before the discharge of the hospital

Secondary Outcomes (4)

  • Satisfaction of the users following the use of the device "Le Qoos"

    During the 48 hours before the discharge of the hospital

  • Frequency of use of the device "Le Qoos" by elderly hospitalized patients.

    During the 48 hours before the discharge of the hospital

  • The most appreciated ergonomic elements

    During the 48 hours before the discharge of the hospital

  • Areas of improvment regarding ergonomics of "Le Qoos"

    During the 48 hours before the discharge of the hospital

Study Arms (3)

old patients

During the first 24 hours of the hospitalisation in the equiped room and before the presentation of the device, A first series of questions will be asked a priori to the patients. Patient will freely use "Le Qoos" during all his hospitalisation. After this use, a survey concerning the usability of "Le Qoos" will be administered to the patient, during the 48 hours before his discharge from hospital.

Other: usability assessment

relatives / unformal caregivers

Before the presentation of the device, a first series of questions will be asked a priori to the unformal caregiver. Unformal caregiver will freely use "Le Qoos" during the hospitalization of his relative. After this use, a survey concerning the usability of "Le Qoos" will be administered to the unformal caregivers, 48 hours before the discharge of his hospitalized relative from hospital.

Other: usability assessment

profesional caregivers

After the inclusion of all expected patients and relatives, a survey concerning the usability of "Le Qoos" will be administered to professional caregivers.

Other: usability assessment

Interventions

Usability of "Le Qoos" will be assessed using a validated usability questionnaire

old patientsprofesional caregiversrelatives / unformal caregivers

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients are recruited during their hospitalisation in geriatric medicine. Relatives / unformal caregivers are recruited during the hospitalisation of patients in geriatric medicine. Professionnal caregivers are recruited in the acute care geriatric unit.

You may qualify if:

  • Patients:
  • Aged 65 years old and over
  • To be hospitalised in geriatric medicine department of Angers University Hospital
  • Caregivers:
  • Family members or relatives
  • Aged 18 years old and over
  • Healthcare team :
  • geriatric medicine department's staff of Angers University Hospital
  • Aged 18 years old and over

You may not qualify if:

  • To be under legal protection
  • Refusal of participating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Angers University Hospital

Angers, 49933 cedex 9, France

Location

MeSH Terms

Conditions

Personal SatisfactionMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Cédric Annweiler, MD, PhD

    Angers University Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2019

First Posted

September 25, 2019

Study Start

September 16, 2019

Primary Completion

September 16, 2020

Study Completion

October 5, 2020

Last Updated

February 24, 2020

Record last verified: 2020-02

Locations