SegwayPD: The Effect of Sensory-augmented Postural Training Using Segway on Motor and Cognitive Function in Individuals With Parkinson's Disease

Обзор

The purpose of this study is to examine the safety and efficacy of postural training emphasized on the integration of multiple sensory information into motor control in individuals with PD. This project is a proof-of-concept study to assess the effectiveness of postural training using Segway, which serves a platform to provide augmented and continuous proprioceptive and visuospatial information during postural training.

Подробное описание

The purpose of this study is to examine the safety and efficacy of postural training emphasized on the integration of multiple sensory information into motor control in individuals with PD (Parkinson's disease). This project is a proof-of-concept study to assess the effectiveness of postural training using Segway, which serves a platform to provide augmented and continuous proprioceptive and visuospatial information during postural training. Specifically, we will measure postural sway during quiet standing, single and dual-task walking performances, and brain activation during single and dual-task walking from the regions involved in planning and execution of locomotion; these include dorsolateral prefrontal cortex, premotor cortex and primary motor cortex. The changes in visuospatial function and proprioception after training will also be assessed. Individuals with moderate disease stage of PD exhibiting postural instability will be recruited. The participants will receive 1-week training and be assessed at 3 time points: 1-week before, before, and after the training.

Вмешательства

• Поведенческое Sensory-Augmented Postural Training
  To examine the safety and efficacy of postural training emphasized on the integration of multiple sensory information into motor control and to assess the effectiveness of postural training using Segway

Первичные конечные точки

• Change from baseline postural sway at week 3 [Срок оценки: Week 1 (2 assessments), Week 3 (1assessment)]

Вторичные конечные точки (3)

• Feasibility of Segway training [Срок оценки: Week 3 (1 assessment)]
• Change from baseline gait spatiotemporal parameters at week 3 [Срок оценки: Week 1 (2 assessments), Week 3 (1assessment)]
• Change from baseline EEG spectral ratio at week 3 [Срок оценки: Week 1 (2 assessments), Week 3 (1assessment)]

Критерии участия

Критерии включения

• a clinical diagnosis of idiopathic PD with moderate disease stage presenting balance alterations (Hoehn and Yahr stage III)
• being stable on medication for at least 1 month
• the ability to stand and walk unsupported for 5 min both on and off medication
• age between 50 and 85

Критерии исключения

• neurological disorders other than PD
• major unstable medical illnesses
• sensory or musculoskeletal disorders (e.g., diabetes, uncorrected visual problems, arthritis, severe hearing impairments) that will prohibit the ability to perform the assessment tests and receive training

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• University of Texas Southwestern Medical Center — Dallas

Идентификаторы

NCT: NCT05982730 · 46179; STU-2023-0066

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗