Satisfaction Clinical Trial
— QUSHIONOfficial title:
Usability Assessment of a Device to Promote Physical Activity for Old Patients Hospitalized
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Status | Withdrawn |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 |
Verified date | February 2020 |
Source | University Hospital, Angers |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |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 |
Country | Name | City | State |
---|---|---|---|
France | Angers University Hospital | Angers |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Angers |
France,
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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