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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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), |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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), |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 14 days |
| the impact of visual biofeedback of the pressure print on chair |
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Inclusion Criteria:
Men or women over 18 years of age,
Daily user of a FR (more than 3 hours per day):
FRE allowing a switchover of at least:
Patient who has signed an informed and written consent,
Affiliation to a social security scheme (beneficiary or beneficiary).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Caroline Hugeron, MD | Hôpital Raymond Poincaré | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Raymond Poincaré | Garches | 92380 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3894415 | Result | 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. | |
| 17136445 | 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. |
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| 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. |
|
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 |
| 14 days |
| 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 | 14 days |
| 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 | 14 days |
| 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 | 14 days |
| 17385269 | 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. |
| ID | Term |
|---|---|
| D020388 | Muscular Dystrophy, Duchenne |
| D009134 | Muscular Atrophy, Spinal |
| ID | Term |
|---|---|
| D009136 | Muscular Dystrophies |
| D020966 | Muscular Disorders, Atrophic |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D040181 | Genetic Diseases, X-Linked |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D016472 | Motor Neuron Disease |
| D019636 | Neurodegenerative Diseases |
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