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

study id #: NCT04335942

condition: Duchenne Muscular Dystrophy, Spinal Muscular Atrophy

status: Not yet recruiting

purpose:

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 ".

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

last updated: February 04, 2022

start date: June 2021

estimated completion: February 2022

last updated: April 9, 2021

phase of development: Not Applicable

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
  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 days
  

secondary outcomes:

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

inclusion 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: 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 01 47 10 70 62, caroline.hugeron@aphp.fr

investigators: Caroline Hugeron, MD,Hôpital Raymond Poincaré

trial center locations: