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 (Es-Alert)

study id #: NCT04335942

condition: Duchenne Muscular Dystrophy; Spinal Muscular Atrophy

status: not yet recruiting

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.

intervention: Alert "AFNOR 3.6", Alertes "AFNOR 3.6" et alertes "Guidelines"

mechanism of action: No pharmaceutical intervention

results: https://clinicaltrials.gov/ct2/show/results/NCT04335942

last updated: August 27, 2020

start date: September 2020

estimated completion: September 2020

phase of development: N/A

size / enrollment: 36

study 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.

primary outcomes:

• 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 [ Time Frame: 14 days ]
  Primary outcome will be evaluated with the number of modification of relief or changing of position with or without alert. The metric used will be the number of average reliefs per hour performed by the patient. This number of reliefs will be compared with and without an alert system.

secondary outcomes:

• The differences in occupational performance at the MCRO (Mesure canadienne du rendement occupationnel) score [ Time Frame: 14 days ]
  Analyze the differences in occupational performance at the MCRO score. An improvement in MCRO score will mean an improvement of occupational performance in psychosocial dimensions.
  
• The impact of visual biofeedback of the pressure print on chair [ Time Frame: 14 days ]
  Quantify the impact of visual biofeedback of the pressure print on chair positioning by modification of the seat within 5 minutes following the visual cartography consultation
  
• Feasibility study of integrating international recommendations to reduce the risk of pressure ulcers in a medical device [ Time Frame: 14 days ]
  The aim is to verify the technical feasibility of integrating international recommendations to reduce the risk of pressure ulcers in a medical device in relation to the position in the chair through: adequacy between pressure cartography the same label posture over time as well as adequacy between the alert and the type of pressure imprint
  
• The study of the acceptability by the patient of alerts in relation with international recommendations [ Time Frame: 14 days ]
  The study of the acceptability by the patient of alerts in relation with international recommendations will be evaluated with the duration of change in alert characteristics by patient after two days of non-modifiable alerts
  
• The study of the acceptability by the patient of alerts in relation with international recommendations [ Time Frame: 14 days ]
  The study of the acceptability by the patient of alerts in relation with international recommendations will be evaluated with the frequency of change in alert characteristics by patient after two days of non-modifiable alerts

inclusion criteria:

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.

sponsor: Assistance Publique - Hôpitaux de Paris

contacts: Caroline Hugeron, MD, 33-014-710-7062, caroline.hugeron@aphp.fr

investigators: Caroline Hugeron, MD, 33-014-710-7062, caroline.hugeron@aphp.fr