Prosthetic Performance Enhancement Trial
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: Flat terrain locomotor training, Uneven terrain locomotor training.
- Кому может быть актуально
- Состояния в реестре: Amputation, Lower Limb Amputation Below Knee (Injury), Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation at Ankle (Injury). 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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Обзор
The purpose of this research is to determine the feasibility of an uneven terrain walking program for lower limb prosthesis users. The training is designed to induce step-to-step variability during walking within a safe environment, with the aim of improving walking skill and confidence.
Подробное описание
Despite advances in the technology for artificial limbs (prostheses), falling and the fear of falling continue to be barriers to mobility for many lower limb prosthesis users after their initial rehabilitation. The loss of ability and confidence in pursuing everyday tasks negatively impacts quality of life, and ongoing physical and mental health. This study will test and improve a rehabilitation training intervention involving walking on uneven ground to improve walking skill and confidence in lower limb prosthesis users.
Lower limb prosthesis users will be recruited. Participants will be allocated randomly to receive either intervention A: training on a flat surface, or intervention B: training on an uneven surface. Depending on their ability and confidence, participants will complete the walking practice either on a treadmill or on a mat with an identical surface pattern. The walking practice will take place three times per week for four weeks. As each participant improves their ability, training tasks will be made more difficult by limiting handrail use, by increasing walking speed, and, for intervention B, also by making the walking surface more uneven.
The objectives of this pilot study are to evaluate adherence and refine the training protocols in preparation for a definitive trial that will inform rehabilitation practices.
Вмешательства
- Другое Flat terrain locomotor training
The training will be comprised of up to 12 sets of 2-min continuous walking on a level treadmill or mat, interspersed with rest breaks of at least one minute. Training will be completed three times per week for four weeks. - Другое Uneven terrain locomotor training
The training will be comprised of up to 12 sets of 2-min continuous walking on an uneven terrain treadmill or mat, interspersed with rest breaks of at least one minute. Training will be completed three times per week for four weeks.
Первичные конечные точки
- Session adherence [Срок оценки: Through study completion, over 4 weeks]
Вторичные конечные точки (12)
- L-test time [Срок оценки: Pre-intervention, within 5 days post intervention]
- Activities-specific Balance Confidence Scale summary score [Срок оценки: Pre-intervention, within 5 days post intervention]
- Average daily activity [Срок оценки: Pre-intervention, within 5 days post intervention]
- Four Square Step Test time [Срок оценки: Pre-intervention, within 5 days post intervention]
- Single leg stand time [Срок оценки: Pre-intervention, within 5 days post intervention]
- Two-minute walk test distance [Срок оценки: Pre-intervention, within 5 days post intervention]
- Protocol acceptability [Срок оценки: End of intervention week 4]
- Recruitment feasibility - recruitment rate [Срок оценки: From start of recruitment period, to 12 month time point.]
- Recruitment feasibility - participating clinics [Срок оценки: Through study completion, from start of recruitment period, to end of recruitment period or 30 month time point, whichever is sooner.]
- Recruitment feasibility - sample characteristics [Срок оценки: Through study completion, from start of recruitment period, to end of recruitment period or 30 month time point, whichever is sooner.]
- Activity data evaluation [Срок оценки: Throughout activity monitoring period, over 2 weeks]
- Maximum relative variability of lateral trunk velocity during uneven terrain in comparison to overground walking [Срок оценки: Through study completion, over 4 weeks]
Критерии участия
Критерии включения
- lower limb amputation at ankle (Symes) level and above
- age 18+ years
- fitted with a walking prosthesis and use it regularly for home and/or community ambulation
- good socket fit, assessed by a score of 8-10 on the socket fit comfort scale
- able to walk for three minutes at a time with or without an assistive device
Критерии исключения
- leg/foot ulcer or other conditions that cause pain during weight-bearing
- poor skin integrity that could cause tissue breakdown by walking
- cardiovascular, respiratory or other critical health conditions that preclude moderate physical activity
- unilateral or bilateral upper limb absence or loss at the wrist and above that precludes use of handrails bilaterally, or would require asymmetrical adaptation to body posture for use.
- pregnancy
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Другое
Центры проведения
США · 1 центр
- University of Nevada Las Vegas — Las Vegas
Идентификаторы
NCT: NCT06419920 · UNLV-2023-595 · CDMRP-OP230011