Characterization of the Postural Habits of Wheelchair Users Analysis of the Acceptability of International Recommendations in the Prevention of Pressure Sores Risk by Using a Connected Textile Sensor
Keywords
Abstract
Description
The main objective of this study is to evaluate the impact of an algorithm that characterizes the cruro-ischiatic fingerprints used in daily life and that issues an alert in case of detection of a pressure sore risk defined by the literature on the occupational performance of the subjects.
The resulting assumption is based on the following points:
- The algorithms implemented in this device are able to calculate and isolate a number of cruro-ischiatic fingerprints used during the day during priority activities and active or passive position changes.
- They may, in the event of a risk position, issue alerts based on the recommendations.
This will allow us to analyze the impact of these alerts on the changes in position and relief actually performed by the subject, analyze the consequences on the MCRO score (psychosocial impact on occupational performance) and verify the impact of visual biofeedback on chair positioning.
Dates
| Last Verified: | 10/31/2019 |
| First Submitted: | 11/21/2019 |
| Estimated Enrollment Submitted: | 04/01/2020 |
| First Posted: | 04/06/2020 |
| Last Update Submitted: | 04/01/2020 |
| Last Update Posted: | 04/06/2020 |
| Actual Study Start Date: | 03/31/2020 |
| Estimated Primary Completion Date: | 03/31/2020 |
| Estimated Study Completion Date: | 09/30/2020 |
Condition or disease
Intervention/treatment
Other: AFNOR 3.6 alerts
Other: AFNOR 3.6 alerts and Guidelines
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Other: AFNOR 3.6 alerts Alert called "AFNOR 3.6" in connection with the dispersion index described by Drummond et al 1985 and validated by Sprigle et al 2003. This alert corresponds to the quantification of the percentage of weight on the slick distributed over a small area (55% on one to three zones totalling 30cm2), | Other: AFNOR 3.6 alerts This alert corresponds to the quantification of the percentage of weight on the slick distributed over a small area (55% on one to three zones totalling 30cm2), |
| Other: AFNOR 3.6 alerts and Guidelines AFNOR 3.6" alerts and "Guidelines" alerts. By alertes Guidelines we mean the clinical recommendations of the Spinal Cord medicine association, i.e. weight relief every 15 to 30 minutes (Bergstrom et al., 1992; Nixon, 1985; Ho and Bogie, 2007) over a period of 1 minute 51 (Coggrave and Rose 2003) for spinal cord injuries. For patients who do not push up, a tilt of at least 25° of seat and 120° of backrest or a minimum of 45° in one block (Dicianno et al. 2009). | Other: AFNOR 3.6 alerts and Guidelines By alertes Guidelines we mean the clinical recommendations of the Spinal Cord medicine association, i.e. weight relief every 15 to 30 minutes over a period of 1 minute 51 for spinal cord injuries. For patients who do not push up, a tilt of at least 25° of seat and 120° of backrest or a minimum of 45° in one block. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - Men or women over 18 years of age, - Daily user of a FR (more than 3 hours per day): - Persons with Duchenne Muscular Dystrophy (DMD) or DMB using an FRE, - People with Infant Spinal Muscular Atrophy (ISA) using an FRE, - WB persons using an MRA with sensitivity disorders (ASIA A). - FRE allowing a switchover of at least: - 25° of the seat and 120° of the backrest, - 45° of sitting in one block, - Patient who has signed an informed and written consent, - Affiliation to a social security scheme (beneficiary or beneficiary). Exclusion Criteria: - Refusal of the patient to participate in the study, - School level lower than cycle 3 not allowing to understand the use of the embedded device, - Severe incontinence, - BM without sensitivity disorders, - Participant in another study or therapeutic trial, - Patient under guardianship or curatorship, - Pregnant women. |
Outcome
Primary Outcome Measures
1. Evaluate the impact of a device, monitoring the wheelchair user's risk of pressure sores and issuing alerts based on international recommendations, on the support reliefs provided by the subject in an ecological situation [14 days]
Secondary Outcome Measures
1. the differences in occupational performance at the MCRO (Mesure canadienne du rendement occupationnel) score [14 days]
2. the impact of visual biofeedback of the pressure print on chair [14 days]
3. Feasibility study of integrating international recommendations to reduce the risk of pressure ulcers in a medical device [14 days]
4. the study of the acceptability by the patient of alerts in relation with international recommendations [14 days]
5. the study of the acceptability by the patient of alerts in relation with international recommendations [14 days]
