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)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Spinal Muscular Atrophy; Duchenne Muscular Dystrophy

Treatments: Other: Alert "AFNOR 3.6".; Other: Alertes " AFNOR 3.6 " et alertes " Guidelines ".

Study type: Interventional

Funder types: Other

Identifiers

NCT04335942

APHP190924

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

AFNOR 3.6 alerts

Other group

Description:

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),

Treatment:

Other: Alert "AFNOR 3.6".

AFNOR 3.6 alerts and Guidelines

Other group

Description:

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).

Treatment:

Other: Alertes " AFNOR 3.6 " et alertes " Guidelines ".