Caracterización de los hábitos posturales de los usuarios de sillas de ruedas Análisis de la aceptabilidad de las recomendaciones internacionales en la prevención del riesgo de úlceras por presión mediante el uso de un sensor textil conectado

ID de estudio #: NCT04335942

condición: Duchenne Muscular Dystrophy, Spinal Muscular Atrophy

Estado: Aún no está reclutando

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.

intervención: Alert "AFNOR 3.6"., Alertes " AFNOR 3.6 " et alertes " Guidelines ".

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

última actualización: Febrero

fecha de inicio: Junio 2021

finalización estimada: Febrero 2022

última actualización: 9 de abril de 2021

fase de desarrollo: No aplicable

tamaño / inscripción: 36

descripción del estudio: 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.

resultados primarios:

• 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
  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.
• 14 días
  

resultados secundarios:

• the differences in occupational performance at the MCRO (Mesure canadienne du rendement occupationnel) score
  14 días
• the impact of visual biofeedback of the pressure print on chair
  14 días
• Feasibility study of integrating international recommendations to reduce the risk of pressure ulcers in a medical device
  14 días
• the study of the acceptability by the patient of alerts in relation with international recommendations
  14 días
• the study of the acceptability by the patient of alerts in relation with international recommendations
  14 días

criterios de inclusión:

Criterio de exclusión: Criterios:

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,
Mujeres embarazadas.

patrocinador: Asistencia pública - Hôpitaux de Paris

Contactos: Caroline Hugeron, MD, +33 01 47 10 70 62, caroline.hugeron@aphp.fr

investigadores Caroline Hugeron, MD,Hôpital Raymond Poincaré

ubicaciones del centro de prueba: