Набор скоро начнётся NCT03494127

User Evaluation of Advanced Personalized Modular Pressure Relief Seating Cushion Systems

Без фазы С лечением Mobility Impairment

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Use of GEL BALL FITTED MODULAR CUSHION, Use of SQUISHINS FITTED MODULAR CUSHION.
Кому может быть актуально: Состояния в реестре: Mobility Impairment. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Development of Advanced Personalized Modular Pressure Relief Seating Cushion Systems: Testing and User Evaluation

Обзор

30 Veterans who are full-time wheelchair users will use personalized modular cushions for two weeks each. Personalized cushions will be created using a cushion fitting process the investigators have already developed and tested. Microenvironmental conditions will be monitored during use. A cost analysis will ensure the customized modular cushion applies value-driven principles. User satisfaction will be measured along with the effects on daily function, skin status and seated tissue health.

Подробное описание

A repeated measures clinical study design will be carried out with 30 Veterans. 'Pre-baseline' seated interface pressures will be assessed with study participants sitting on their own cushions and pelvic region skin checks carried out by the study Research Nurse. All participants will then receive customized modular cushions. Participants will be randomly assigned to Group A or Group B using a modified randomization scheme. Group A participants will first use a gel ball fitted cushion for 2 weeks during all daily living activities while seated in their wheelchair followed by use of a SquishINS fitted cushion for 2 weeks. Group B will first use the SquishINS fitted cushion then a gel ball fitted cushion. Seated interface pressure distribution will be obtained at the beginning and end of each test period. A dual temperature and humidity sensor placed in the cushion will enable continuous monitoring of microenvironmental status during use. The study Research Nurse will repeat the pelvic region skin check and participants will complete a questionnaire based on the QUEST 2.0 user satisfaction instrument. All responses will be documented as part of the QS/DC program.

Вмешательства

Устройство Use of GEL BALL FITTED MODULAR CUSHION
DAILY COMMUNITY USE OF GEL BALL FITTED MODULAR CUSHION for 2 weeks
Устройство Use of SQUISHINS FITTED MODULAR CUSHION
DAILY COMMUNITY USE OF SQUISHINS FITTED MODULAR CUSHION for 2 weeks

Первичные конечные точки

Seated interface pressure distribution [Срок оценки: After each 2 week period of cushion use for 5 minutes at each assessment]
Microenvironmental status I - temperature [Срок оценки: Continuously during each 2 week period of cushion use]
Microenvironmental status II - humidity [Срок оценки: Continuously during each 2 week period of cushion use]

Вторичные конечные точки (1)

User satisfaction questionnaire [Срок оценки: After each 2 week period of cushion use for 5 minutes at each assessment]

Критерии участия

Критерии включения

Veterans with mobility impairments requiring full time use of a power or manual wheelchair who are served through the LSCDVAMC Wheeled Mobility Clinic.