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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)

Primary Purpose

Duchenne Muscular Dystrophy, Spinal Muscular Atrophy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Alert "AFNOR 3.6".
Alertes " AFNOR 3.6 " et alertes " Guidelines ".
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Duchenne Muscular Dystrophy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hôpital Raymond Poincaré

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

AFNOR 3.6 alerts

AFNOR 3.6 alerts and Guidelines

Arm 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),

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

the differences in occupational performance at the MCRO (Mesure canadienne du rendement occupationnel) score
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.
the impact of visual biofeedback of the pressure print on chair
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
Feasibility study of integrating international recommendations to reduce the risk of pressure ulcers in a medical device
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
the study of the acceptability by the patient of alerts in relation with international recommendations
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
the study of the acceptability by the patient of alerts in relation with international recommendations
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

Full Information

First Posted
November 22, 2019
Last Updated
August 30, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT04335942
Brief Title
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
Acronym
Es-Alert
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 30, 2021 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
June 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Duchenne Muscular Dystrophy, Spinal Muscular Atrophy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AFNOR 3.6 alerts
Arm Type
Other
Arm 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),
Arm Title
AFNOR 3.6 alerts and Guidelines
Arm Type
Other
Arm 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).
Intervention Type
Other
Intervention Name(s)
Alert "AFNOR 3.6".
Intervention Description
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),
Intervention Type
Other
Intervention Name(s)
Alertes " AFNOR 3.6 " et alertes " Guidelines ".
Intervention Description
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 Outcome Measure Information:
Title
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
Description
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.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
the differences in occupational performance at the MCRO (Mesure canadienne du rendement occupationnel) score
Description
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.
Time Frame
14 days
Title
the impact of visual biofeedback of the pressure print on chair
Description
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
Time Frame
14 days
Title
Feasibility study of integrating international recommendations to reduce the risk of pressure ulcers in a medical device
Description
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
Time Frame
14 days
Title
the study of the acceptability by the patient of alerts in relation with international recommendations
Description
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
Time Frame
14 days
Title
the study of the acceptability by the patient of alerts in relation with international recommendations
Description
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
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline Hugeron, MD
Organizational Affiliation
Hôpital Raymond Poincaré
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Raymond Poincaré
City
Garches
ZIP/Postal Code
92380
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
3894415
Citation
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.
Results Reference
result
PubMed Identifier
17136445
Citation
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.
Results Reference
result
PubMed Identifier
17385269
Citation
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.
Results Reference
result

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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

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