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Набира участници NCT05989243

Improving Socket Fit in Female and Male Veterans With Transtibial and Transfemoral Amputation

Заболявания: Transtibial Amputation Transfemoral Amputation

Спонсор: VA Office of Research and Development

Налично на: БГ
Обобщение
The investigators do not yet know how a prosthetic socket with adjustable panels affects the performance of people with a lower limb amputation compared to a conventional prosthetic socket. The primary objective of this study is to compare an adjustable and conventional prosthetic socket and use this information to determine the optimal socket that would improve rehabilitation and function in people with lower limb amputation.
Описание
The purpose of the project is to determine the effects of using different prosthetic socket designs with the same suspension and components on the biomechanical asymmetry, residual limb movement within the socket (socket pistoning) and comfort/satisfaction of 20 Veterans with a transtibial amputation and 20 Veterans with a transfemoral amputation, 10 males and 10 females per group.
Кой може да участва
Inclusion Criteria: * The investigators will enroll up to 40 Veterans * 20 with unilateral transtibial amputation * 20 with unilateral transfemoral amputation who are at or above a K2 Medicare functional classification level (MFCL) and who are 18-65 years old * All participants will have no current problems with their prosthesis or residual limb, and be at least 6-months post-amputation * Participants will be at or above a K2 MFCL, defined as a person who has the ability or potential for ambulation with the ability to traverse low level environmental barriers such as curbs, stairs, or uneven surfaces, typical of the limited community ambulator Exclusion Criteria: * Cardiovascular, pulmonary, or neurological disease or disorder or requirement for an assistive device for their unaffected leg (i.e. orthosis, cane)
Интервенции
Conventional prosthetic socket
DEVICE
Adjustable Quatro socket
DEVICE
Места на провеждане 1
САЩ (1)
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora , Colorado
Технически детайли
Статус
Набира участници
Вид изследване
OBSERVATIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
65 Years
Здрави доброволци
Не
Начална дата
31.01.2022
Крайна дата
31.03.2027
Регистрационен номер
NCT05989243
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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