Status:

COMPLETED

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

Lead Sponsor:

Assistance Publique - Hôpitaux de Paris

Conditions:

Duchenne Muscular Dystrophy

Spinal Muscular Atrophy

Eligibility:

All Genders

18+ years

Phase:

NA

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 ...

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 pre...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

September 30 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2023

Estimated Enrollment :

36 Patients enrolled

Trial Details

Trial ID

NCT04335942

Start Date

September 30 2021

End Date

June 1 2023

Last Update

August 31 2023

Active Locations (1)

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1

Hôpital Raymond Poincaré

Garches, France, 92380