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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04103827
Other study ID # 2019/40
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date September 16, 2019
Est. completion date October 5, 2020

Study information

Verified date February 2020
Source University Hospital, Angers
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

This satisfaction survey will be carried out in the Geriatrics department of the University Hospital of Angers. Actually, Le Qoos and is environment is installed in a hospitalisation room of the geriatric unit. When the patient entered the room, a first series of questions are asked a priori concerning the device. These questions are also asked to the relatives of the patient if any, and to the professional caregivers of the unit. After this first series of questions, a list of possible exercises is given to the patients, regrading is functional capabilities according to the EGS-1, with some explanations. The proposed exercises correspond to 3 selected actions based on the results of scientific research conducted by the team at the University Hospital of Angers to prevent the risks of iatrogenic dependence. Then, the patient and is relatives, if any, are free to use the device during the all hospitalisation. During the 48h before the discharge from the hospital, a second list of questions will be asked to assess the usability and the satisfaction concerning the device.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date October 5, 2020
Est. primary completion date September 16, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- To be under legal protection

- Refusal of participating

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France Angers University Hospital Angers

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Satisfaction of the users following the use of the device "Le Qoos" The satisfaction will be assessed using a non-validated satisfaction questionnaire based on a forced choice Likert scale in 4 points from 1 to 4. The mean score obtained by users will be used. Users will be considered as satisfied if the mean score is over 2 on 4. During the 48 hours before the discharge of the hospital
Secondary Frequency of use of the device "Le Qoos" by elderly hospitalized patients. The frequency of use will be described using a non-validated questionnary based on 4 closed questions. During the 48 hours before the discharge of the hospital
Secondary The most appreciated ergonomic elements The ergonomic elements will be assessed using a single choice closed liste of ergonomic elements. The most ergonomic elements will be ranked in descending order of citation by users. During the 48 hours before the discharge of the hospital
Secondary Areas of improvment regarding ergonomics of "Le Qoos" A single open question will be asked for users concerning elements to improve. A qualitative thematic analyze of the verbatim will be realized to identify the elements to improve, During the 48 hours before the discharge of the hospital
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