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NCT Number: NCT04335942

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

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.

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Key information

Conditions

Duchenne Muscular Dystrophy Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Motor Neuron Disease Muscular Atrophy, Spinal Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy, Duchenne Musculoskeletal Diseases Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Spinal Cord Diseases Spinal Muscular Atrophy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Raymond Poincaré

Garches, 92380, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alert "AFNOR 3.6".

Other

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),

Alertes " AFNOR 3.6 " et alertes " Guidelines ".

Other

By alertes Guidelines we mean the clinical recommendations of the Spinal Cord medicine association, i.e. weight relief every 15 to 30 minutes over a period of 1 minute 51 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.

Primary outcomes

  1. 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

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Characterization of the Postural Habits of Wheelchair Users in an Ecological Situation and Analysis of the Acceptability of International Recommendations in the Prevention of Pressure Sores Risk by Using a Connected Textile Sensor Integrating an Artificial Intelligence Algorithm

Acronym: Es-Alert

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 7, 2020
Registry last updated
Aug 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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