Position Sense Disorders
Conditions
Brief summary
The aim of this clinical investigation is to develop a reliable and valid device to instantly measure the subject's sitting posture in a wheelchair, without using the MCPAA scale.
Detailed description
Each subject will be invited to a single experimental session lasting approximately one hour, during which all assessments will be performed. During the visit, the patient will complete an autonomy questionnaire and assess wheelchair fatigue. A spirometry test will be performed. The measurements will then be recorded by the BePoW software and the occupational therapist.
Interventions
DEVICEPosition measurement with BePow
14 measurements taken with the device
OTHERPosition measurement with MCPAA scale
MCPAA : measurement of seated postural control in adults in French 12 measurements taken with the goniometer
Sponsors
Pôle Saint Hélier
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
exploratory, monocentric, reliability-validity clinical investigation
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Over 18 years of age, * Having freely consented to participate in the study (or their legal representative in the case of guardianship, in agreement with the patient), * In the case of a guardianship, the legal representative having read the information document intended for the legal guardian of an adult under legal protection (under guardianship) and given his/her free and informed consent for the person for whom he/she is responsible to participate in the study (in agreement with the patient). * Temporarily or permanently wheelchair-bound, * Affiliated with a social security scheme or beneficiary of such a scheme.
Exclusion criteria
* Has comprehension problems that prevent him/her from giving free and informed consent and from completing the investigation (following instructions, answering questionnaires), * Suffering from a pathology (Huntington's disease, Sydenham's Chorea) preventing stable sitting posture during participation in the investigation, * Have undergone an amputation that prevents the BePoW device from taking measurements, * having undergone a tracheotomy preventing spirometry. * Pregnant, parturient or breast-feeding women, * Person deprived of liberty by a judicial decision (except guardianship or curatorship) or or administrative decision, a person under psychiatric care or admitted to a or social establishment for purposes other than research, * Minors, * Person in an emergency situation unable to give prior consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reliability assessment: intraclass correlation coefficient (ICC) between BePoW measurements | Immediately after inclusion | 12 data records for each measurement for intra ICC |
| Validity assessment: correlation coefficient r between raw goniometric measurements and BePoW measurements, | Immediately after inclusion | kappa coefficient between recoded measurements : BePow / MCPAA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessing the validity of BePoW measurements in relation to respiratory capacity | Immediately after inclusion | assessed by the ratio of forced expiratory volume in one second (FEV1) to FEV1 at 6 seconds (FEV 6). Spirometry will be performed 3 times, with the highest value retained. |
| Assess the validity of BePoW measurements in relation to fatigability. | Immediately after inclusion | assessment using a visual numerical scale, from 0 to 10 |
| Determining the minimum detectable change (MDC) on angular measurements taken by BePoW | Immediately after inclusion | Calculation of the minimum detectable change (MDC) of each measurement taken by the device. |
| Determine the standard error measurement (SEM) on angular measurements taken by BePoW | Immediately after inclusion | Calculation of the standard error measurement (SEM) of each measurement taken by the device. |
| Assess the validity of BePoW measurements in relation to autonomy. | Immediately after inclusion | assessment by the MIF (Measure of Functional Independence) questionnaire from 21 (total dependence) to 47 (completely independent) |
Countries
France
Outcome results
None listed