Clinical trial NCT04335942: 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
Official title: Characterization of the Postural Habits of Wheelchair Users in an Ecological Situation and Analysis of the Acceptability of International Recommendations in the Prevention of Pressure Sores Risk by Using a Connected Textile Sensor Integrating an Artificial Intelligence Algorithm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Duchenne Muscular Dystrophy
Spinal Muscular Atrophy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-04-07
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Spinal cord injuries and people with Duchenne Muscular Dystrophy or Infant Spinal Muscular Atrophy (ISA) are prone to pain and pressure sores associated with prolonged sitting. For this reason, it is recommended that people with spinal cord injuries release pressure every 15 to 30 minutes and motorized wheelchair users use the electric positioning functions at least 1 minute every hour.

The aim is to prevent and/or reduce pain and pressure sores. These devices could help to observe daily the variability of users' pressure maps, their impact on occupational performance, the link with pain and redness and could propose customized adjustments.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: 14 days
Secondary outcomes:
measure: the differences in occupational performance at the MCRO (Mesure canadienne du rendement occupationnel) score
timeFrame: 14 days
measure: the impact of visual biofeedback of the pressure print on chair
timeFrame: 14 days
measure: Feasibility study of integrating international recommendations to reduce the risk of pressure ulcers in a medical device
timeFrame: 14 days
measure: the study of the acceptability by the patient of alerts in relation with international recommendations
timeFrame: 14 days
measure: the study of the acceptability by the patient of alerts in relation with international recommendations
timeFrame: 14 days
Other outcomes:
Locations:
city: Garches
country: France
facility: Hôpital Raymond Poincaré
Study officials:
affiliation: Hôpital Raymond Poincaré
name: Caroline Hugeron, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Drummond D, Breed AL, Narechania R. Relationship of spine deformity and pelvic obliquity on sitting pressure distributions and decubitus ulceration. J Pediatr Orthop. 1985 Jul-Aug;5(4):396-402. doi: 10.1097/01241398-198507000-00002.
citation: Gawlitta D, Li W, Oomens CW, Baaijens FP, Bader DL, Bouten CV. The relative contributions of compression and hypoxia to development of muscle tissue damage: an in vitro study. Ann Biomed Eng. 2007 Feb;35(2):273-84. doi: 10.1007/s10439-006-9222-5. Epub 2006 Nov 29.
citation: Sprigle S, Maurer C, Holowka M. Development of valid and reliable measures of postural stability. J Spinal Cord Med. 2007;30(1):40-9. doi: 10.1080/10790268.2007.11753913.