Spinal Cord InjuryGASPARD-SCINCT05403606
"Guarantee Assessment in Skin Prevention Adapted to Real Life With a Connected Device After a Spinal Cord Injury."
A study testing GASPARD® in people with Spinal Cord Injury, run by Nantes University Hospital at 1 site in France.
Trial summary
The investigators propose to test an embedded device on the seat of the wheelchair of paraplegic or tetraplegic patients (Gaspard), allowing on the one hand the continuous measurement of the pressures of seat, on the other hand a retro-control connected to the cell phone of the participants to inform them on these… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- GASPARD®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2023to 3 Feb 2026
- 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
- Patients of both sexes with acquired spinal cord injury Traumatic or non-traumatic origin of the spinal cord injury
- Motor level < C6
- Complete or incomplete injury (AIS A, B and C impairment scale)
- Primarily using a manual wheelchair (with or without electric propulsion assistance) as a means of mobility
- At least 18 years of age
- At any time after the occurrence of the spinal cord injury
Show all 12Show fewer
- Patients discharged from the center, with a first post-injury rehabilitation completed
- Having participated in a specific therapeutic patient education on pressure ulcer prevention
- No pelvic pressure sores under medical or surgical treatment at the time of inclusion
- No aorto-iliac arterial disease that may promote pelvic ischemia (arterial Doppler <6 months)
- Patient using a cushion approved by the HAS
- Patients with a smartphone
Who cannot join
- Congenital spinal cord injury
- Motor level of the lesion > or = C6
- Incomplete motor lesion (AIS D and E)
- Patients who walk as their primary mode of ambulation
- Use of an electric wheelchair
- Minors
Trial locations and contacts
1 site in 1 country.
About this study
The investigators propose to test an embedded device on the seat of the wheelchair of paraplegic or tetraplegic patients (Gaspard), allowing on the one hand the continuous measurement of the pressures of seat, on the other hand a retro-control connected to the cell phone of the participants to inform them on these variables of seat (bad positioning, prolonged supports etc...) This study will be carried out over a long period of time (1 year), in an ergonomic situation of integration in the daily life of the participants. The main objective of this randomized controlled study is to study the difference in the incidence of pressure sores according to the use or not of this device. A qualitative study of the experience and perceived benefit of its use and a medico-economic study are associated to judge the expected interest in making this type of embedded device more systematically integrated into the classic movement equipment (wheelchair and seat cushion) of people with a spinal cord injury
- Conditions
- Spinal Cord Injury
- Being tested
- GASPARD®
- Keywords
- spinal cord injury, pressure ulcer, prevention, medical advice, visual feedback
- Medical subject headings
- Spinal Cord Injuries, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GASPARD®Device
Spinal cord injured patient with the connected electronic seat pressure measurement device (GASPARD®), a traditional follow-up and having received therapeutic education at the end of the treatment
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group (GASPARD®) | Experimental | Spinal cord injured patient with the connected electronic seat pressure measurement device (GASPARD®), a traditional follow-up and having received therapeutic education at the end of the treatment Receives: Device: GASPARD® |
| Control group: | No intervention | Spinal cord injured patient with traditional follow-up with therapeutic education at discharge from initial care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients per group for whom a pressure ulcer occurred.
Measured: 1 year
Secondary outcomes (6)
Incremental cost-utility ratio of a connected electronic seat pressure measurement device (GASPARD®) compared to traditional management (= without device)
Measured: 1 year
Skin Risk Knowledge Questionnaire Revised-SMNAC (Skin Management Needs Assessment Checklist)
Measured: 1 year
Cross-analysis and thematic analysis of the comments made during the focus groups, particularly with regard to the perception of one's ability to take charge of one's health and the connected dimension of the device.
Measured: 1 year
Frequency of pelvic location of pressure ulcer (sacrum, ischium, trochanters). Frequency of pressure ulcer stages (1 to 4)
Measured: 1 year
Number of pressure sores per patient
Measured: 1 year
Analysis of Hospital Anxiety and Depression Scale (HADS) scores and International Pain Data Set variables.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start1 Jan 2023
- Primary completion3 Feb 2026
- Study completion3 Feb 2026
Why it stopped: lack of inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MARC LE FORT, Principal investigator, Nantes University HospitalGAELLE AUDAT, Principal investigator, CRRF l'ArcheRECH CELIA, Principal investigator, Raymond Poincaré HospitalKERDRAON Jacques, Principal investigator, CRRF KerpapeGELIS ANTHONY, Principal investigator, Centre Mutualiste Neurologique Propora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05403606
- Sponsor's protocol ID
- RC21_0044
- Acronym
- GASPARD-SCI
- Status last verified
- Apr 2026
- First submitted
- 19 May 2022
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Guarantee Assessment in Skin Prevention Adapted to Real Life With a Connected Device After a Spinal Cord Injury."
- ClinicalTrials.gov ID
- NCT05403606
- Acronym / sponsor ID
- GASPARD-SCI / RC21_0044
- Conditions
- Spinal Cord Injury
- Keywords
- spinal cord injury, pressure ulcer, prevention, medical advice, visual feedback
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of inclusion
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 3 Feb 2026 (actual)
- Study completion
- 3 Feb 2026 (actual)
- First posted
- 3 Jun 2022 (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 investigators propose to test an embedded device on the seat of the wheelchair of paraplegic or tetraplegic patients (Gaspard), allowing on the one hand the continuous measurement of the pressures of seat, on the other hand a retro-control connected to the cell phone of the participants to inform them on these variables of seat (bad positioning, prolonged supports etc...) This study will be carried out over a long period of time (1 year), in an ergonomic situation of integration in the daily life of the participants. The main objective of this randomized controlled study is to study the difference in the incidence of pressure sores according to the use or not of this device. A qualitative study of the experience and perceived benefit of its use and a medico-economic study are associated to judge the expected interest in making this type of embedded device more systematically integrated into the classic movement equipment (wheelchair and seat cushion) of people with a spinal cord injury
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (GASPARD®) | Experimental | Device: GASPARD®Spinal cord injured patient with the connected electronic seat pressure measurement device (GASPARD®), a traditional follow-up and having received therapeutic education at the end of the treatment |
| Control group: | No intervention | –Spinal cord injured patient with traditional follow-up with therapeutic education at discharge from initial care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients of both sexes with acquired spinal cord injury Traumatic or non-traumatic origin of the spinal cord injury
Key exclusion criteria (6 listed)
- Congenital spinal cord injury
- Motor level of the lesion > or = C6
- Incomplete motor lesion (AIS D and E)
- Patients who walk as their primary mode of ambulation
- Use of an electric wheelchair
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 |
|---|---|---|
| GASPARD®Spinal cord injured patient with the connected electronic seat pressure measurement device (GASPARD®), a traditional follow-up and having received therapeutic education at the end of the treatment | Device | Experimental Group (GASPARD®) |
Primary outcome
Percentage of patients per group for whom a pressure ulcer occurred.
Time frame: 1 year
6 secondary outcomes
Incremental cost-utility ratio of a connected electronic seat pressure measurement device (GASPARD®) compared to traditional management (= without device)
Time frame: 1 year
Skin Risk Knowledge Questionnaire Revised-SMNAC (Skin Management Needs Assessment Checklist)
Time frame: 1 year
Cross-analysis and thematic analysis of the comments made during the focus groups, particularly with regard to the perception of one's ability to take charge of one's health and the connected dimension of the device.
Time frame: 1 year
Frequency of pelvic location of pressure ulcer (sacrum, ischium, trochanters). Frequency of pressure ulcer stages (1 to 4)
Time frame: 1 year
Number of pressure sores per patient
Time frame: 1 year
Analysis of Hospital Anxiety and Depression Scale (HADS) scores and International Pain Data Set variables.
Time frame: 1 year
Results and safety
The study was stopped early (reason given: lack of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
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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.
MARC LE FORT principal investigator
Nantes University Hospital
GAELLE AUDAT principal investigator
CRRF l'Arche
RECH CELIA principal investigator
Raymond Poincaré Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GASPARD® in people with Spinal Cord Injury, run by Nantes University Hospital 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 12 inclusion and 6 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: stopped early, as of the sponsor's last update on 20 Apr 2026. 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 was stopped early (reason given: lack of inclusion). Results are not available in the source record.
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?
Percentage of patients per group for whom a pressure ulcer occurred. (time frame: 1 year). 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 20 Apr 2026.