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)

• ClinicalTrials.gov Identifier: NCT04335942
• Recruitment Status: Recruiting
• First Posted: April 7, 2020
• Last Update Posted: October 13, 2022
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

Study Description

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 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.

Condition or disease	Intervention/treatment	Phase
Duchenne Muscular Dystrophy; Spinal Muscular Atrophy	Other: Alert "AFNOR 3.6".; Other: Alertes " AFNOR 3.6 " et alertes " Guidelines ".	Not Applicable

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 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official 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
• Actual Study Start Date: September 30, 2021
• Estimated Primary Completion Date: March 2023
• Estimated Study Completion Date: March 2023

Arms and Interventions

Arm	Intervention/treatment
AFNOR 3.6 alerts; 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),	Other: Alert "AFNOR 3.6".; 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),
AFNOR 3.6 alerts and Guidelines; 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).	Other: Alertes " AFNOR 3.6 " et alertes " Guidelines ".; 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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

• 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.

Contacts and Locations

Contacts

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

Contact: Antoine Perrier, PhD; +33 06.83.54.13.08; perrier.antoine@gmail.com

Locations

France

Hôpital Raymond Poincaré; Recruiting

Garches, France, 92380

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

• Principal Investigator: Caroline Hugeron, MD; Hôpital Raymond Poincaré

More Information

Publications of Results:

Drummond D, Breed AL, Narechania R. Relationship of spine deformity and pelvic obliquity on sitting pressure distributions and decubitus ulceration. J Pediatr Orthop. 1985 Jul-Aug;5(4):396-402. doi: 10.1097/01241398-198507000-00002.

Gawlitta D, Li W, Oomens CW, Baaijens FP, Bader DL, Bouten CV. The relative contributions of compression and hypoxia to development of muscle tissue damage: an in vitro study. Ann Biomed Eng. 2007 Feb;35(2):273-84. doi: 10.1007/s10439-006-9222-5. Epub 2006 Nov 29.

Sprigle S, Maurer C, Holowka M. Development of valid and reliable measures of postural stability. J Spinal Cord Med. 2007;30(1):40-9. doi: 10.1080/10790268.2007.11753913.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT04335942
• Other Study ID Numbers: APHP190924
• First Posted: April 7, 2020
• Last Update Posted: October 13, 2022
• Last Verified: October 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Muscular Dystrophies; Muscular Dystrophy, Duchenne; Muscular Atrophy; Muscular Atrophy, Spinal; Pressure Ulcer; Atrophy; Pathological Conditions, Anatomical; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Neuromuscular Manifestations; Neurologic Manifestations; Spinal Cord Diseases; Central Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; Skin Ulcer; Skin Diseases