Experimental PBT Study in Fall-prone Subjects

Официальное название

Experimental Perturbation-based-training Study in Patients After Stroke and Older Adults

Обзор

The study will investigate safety, usability, feasibility and preliminary efficacy of perturbation-based training in participants post-stroke and older adults with mild balance deficits. Both group will receive three weks of training. The primary outcome measure will be derived from laboratory-induced falls.

Подробное описание

Two convenience samples will be recruited to serve as self-controls, 20 post-stroke adults and 30 community-dwelling older adults. Participants post stroke will be recruited after discharge from their regular rehabilitation. Each subject will undergo individually customised perturbation-based training sessions with safety harnesses. The participants will be assessed at four time points: at baseline, after 3 weeks (at the beginning of training), at the end of 3-week training, and at 3-week follow-up. Safety, usability and efficacy of training will be evaluated using slip-, trip- and platform-movement-based perturbations induced by a Stewart platform and dual-belt treadmill, whereby the perturbation strength that can be reliably counteracted will be recorded, and using standardised clinical outcome measures.

Вмешательства

• Устройство PBT
  Each subject will undergo 9 perturbation-based training sessions with safety harnesses, and the device will deliver waist pulls during treadmill walking. Training sessions will be individually customised. Perturbation intensity will be progressively increased by a physiotherapist according to the subject's abilities. Training sessions will last approximately 30 minutes, 2-3 times per week.

Первичные конечные точки

• Perturbation strength [Срок оценки: Difference between the two assessments - one day before the first and one day after the last training session]

Вторичные конечные точки (2)

• mini-BESTest [Срок оценки: Difference between the two assessments - one day before the first and one day after the last training session]
• ABC Scale [Срок оценки: Difference between the two assessments - one day before the first and one day after the last training session]

Критерии участия

Inclusion Criteria for both arms:

• ability for independent community walking without aids;
• sufficient cognitive, visual, and communication abilities for study participation.

Exclusion Criteria for both arms:

• musculoskeletal impairments;
• cardiovascular health-related problems;
• other health conditions that could interfere with the training.

Additional Inclusion Criteria for post-stroke patients:

• discharge from their regular rehabilitation;
• at least 6 months after first unilateral cerebral stroke;
• 18 to 70 years of age;
• absence of additional neurologic conditions.

Additional Inclusion Criteria for older adults:

• age 65 to 75 years;
• no known health-related problems significantly affecting balance and walking.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Словения · 1 центр

• University Rehabilitation Institute, Republic of Slovenia — Ljubljana

Публикации

• Olensek A, Zadravec M, Matjacic Z. A novel methodological approach for inducing slips, trips and pelvic pulls during treadmill walking. Annu Int Conf IEEE Eng Med Biol Soc. 2025 Jul;2025:1-7. doi: 10.1109/EMBC58623.2025.11251529. PMID 41336813

Идентификаторы

NCT: NCT07654335 · URIS202601

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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