Position Sense DisordersSAPANCT06239012
Reliability and Validity Evaluation of the BePoW Device
A study testing Position measurement with BePow and Position measurement with MCPAA scale in people with Position Sense Disorders, run by Pôle Saint Hélier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Position Sense Disorders
- What is being tested?
- Position measurement with BePow and Position measurement with MCPAA scale
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 29 Feb 2024to 3 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SAPA Study (Seated Posture Analysis System) : Reliability and Validity Evaluation of the BePoW Device
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.
Read the 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.
- Conditions
- Position Sense Disorders
- Being tested
- Position measurement with BePow, Position measurement with MCPAA scale
- Medical subject headings
- Somatosensory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Position measurement with BePowDevice
14 measurements taken with the device
Position measurement with MCPAA scaleOther
MCPAA : measurement of seated postural control in adults in French 12 measurements taken with the goniometer
| Study group | Role | What they receive |
|---|---|---|
| position measurement with BePoW device compared with MCPAA scale measurements | Experimental | Each patient will have position measurement with BePoW device and, at the same time, will have MCPAA scale measurements Receives: Device: Position measurement with BePow; Other: Position measurement with MCPAA scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability assessment: intraclass correlation coefficient (ICC) between BePoW measurements
12 data records for each measurement for intra ICC
Measured: Immediately after inclusion
Validity assessment: correlation coefficient r between raw goniometric measurements and BePoW measurements,
kappa coefficient between recoded measurements : BePow / MCPAA
Measured: Immediately after inclusion
Secondary outcomes (5)
Assess the validity of BePoW measurements in relation to fatigability.
assessment using a visual numerical scale, from 0 to 10
Measured: Immediately after inclusion
Assess the validity of BePoW measurements in relation to autonomy.
assessment by the MIF (Measure of Functional Independence) questionnaire from 21 (total dependence) to 47 (completely independent)
Measured: Immediately after inclusion
Assessing the validity of BePoW measurements in relation to respiratory capacity
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.
Measured: Immediately after inclusion
Determine the standard error measurement (SEM) on angular measurements taken by BePoW
Calculation of the standard error measurement (SEM) of each measurement taken by the device.
Measured: Immediately after inclusion
Determining the minimum detectable change (MDC) on angular measurements taken by BePoW
Calculation of the minimum detectable change (MDC) of each measurement taken by the device.
Measured: Immediately after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start29 Feb 2024
- Primary completion3 Dec 2024
- Study completion3 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Position Sense DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- exploratory, monocentric, reliability-validity clinical investigation
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pôle Saint Hélier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239012
- Sponsor's protocol ID
- 2023-A00609-36
- Acronym
- SAPA
- Status last verified
- Jul 2025
- First submitted
- 25 Jan 2024
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAPA Study (Seated Posture Analysis System) : Reliability and Validity Evaluation of the BePoW Device
- ClinicalTrials.gov ID
- NCT06239012
- Acronym / sponsor ID
- SAPA / 2023-A00609-36
- Conditions
- Position Sense Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pôle Saint HélierUniversity, hospital or other
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 3 Dec 2024 (actual)
- Study completion
- 3 Dec 2024 (actual)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- exploratory, monocentric, reliability-validity clinical investigation
| Arm | Type | Receives |
|---|---|---|
| position measurement with BePoW device compared with MCPAA scale measurements | Experimental | Device: Position measurement with BePow, Other: Position measurement with MCPAA scaleEach patient will have position measurement with BePoW device and, at the same time, will have MCPAA scale measurements |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Position measurement with BePow14 measurements taken with the device | Device | position measurement with BePoW device compared with MCPAA scale measurements |
| Position measurement with MCPAA scaleMCPAA : measurement of seated postural control in adults in French 12 measurements taken with the goniometer | Other | position measurement with BePoW device compared with MCPAA scale measurements |
Primary outcome
Reliability assessment: intraclass correlation coefficient (ICC) between BePoW measurements
Time frame: Immediately after inclusion
12 data records for each measurement for intra ICC
Validity assessment: correlation coefficient r between raw goniometric measurements and BePoW measurements,
Time frame: Immediately after inclusion
kappa coefficient between recoded measurements : BePow / MCPAA
5 secondary outcomes
Assess the validity of BePoW measurements in relation to fatigability.
Time frame: Immediately after inclusion
Assess the validity of BePoW measurements in relation to autonomy.
Time frame: Immediately after inclusion
Assessing the validity of BePoW measurements in relation to respiratory capacity
Time frame: Immediately after inclusion
Determine the standard error measurement (SEM) on angular measurements taken by BePoW
Time frame: Immediately after inclusion
Determining the minimum detectable change (MDC) on angular measurements taken by BePoW
Time frame: Immediately after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Position measurement with BePow and Position measurement with MCPAA scale in people with Position Sense Disorders, run by Pôle Saint Hélier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability assessment: intraclass correlation coefficient (ICC) between BePoW measurements (time frame: Immediately after inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.