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

NCT04335942 | Completed

• 1 other identifier: APHP190924
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Duchenne Muscular Dystrophy; Spinal Muscular Atrophy

Outcome Measures

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

  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 (5)

• 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

Study Arms (2)

AFNOR 3.6 alerts

OTHER

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".

AFNOR 3.6 alerts and Guidelines

OTHER

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 ".

Interventions

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),

AFNOR 3.6 alerts

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.

AFNOR 3.6 alerts and Guidelines

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• ° of the seat and 120° of the backrest,
• ° of sitting in one block,
• Patient who has signed an informed and written consent,
• Affiliation to a social security scheme (beneficiary or beneficiary).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Raymond Poincaré

Garches, 92380, France

Location

Related Publications (3)

• 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.

  PMID: 3894415 RESULT

• 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.

  PMID: 17136445 RESULT

• 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.

  PMID: 17385269 RESULT

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne; Muscular Atrophy, Spinal

Condition Hierarchy (Ancestors)

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

Study Officials

• Caroline Hugeron, MD

  Hôpital Raymond Poincaré

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2019
• First Posted: April 7, 2020
• Study Start: September 30, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)