A Pilot Study of In-lab Dynamic Standing in Parkinson's Disease

Обзор

This research is studying the use of a new type of standing desk in a small number of people to learn about the user experience for people with Parkinson's disease. 12 4-hour sessions will be performed to test the primary hypothesis that dynamic standing improves gait function compared to static standing and control sitting. This study has 2 phases. Phase 1 will be an open-label study and Phase 2 will be an in-lab randomized controlled trial pilot study. This is phase 1 of the study.

Подробное описание

For phase 1, participants will attend up to 12 4-hour sessions using the dynamic standing desk. In addition to these sessions, there will be a clinical assessment at baseline and an outcome session (endpoint assessments). In total, there will be up to 14 sessions per participant. All sessions need to be completed within 6 weeks. At the baseline session, clinical measurements will be collected. These measures will be repeated in the outcome session.

Вмешательства

• Устройство Dynamic Standing Desk
  Participants will stand at the desk for 4 hours per session. During each session, the desk will move to prompt the participant to take small steps. Participants will take breaks as needed. Each participant will complete up to 12 sessions in the span of 6 weeks.

Первичные конечные точки

• Gait Speed [Срок оценки: Baseline and post-intervention (up to 6 weeks).]
• Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III [Срок оценки: Baseline and post-intervention (up to 6 weeks).]
• Montreal Cognitive Assessment [Срок оценки: Baseline and post-intervention (up to 6 weeks).]
• Timed Up and Go [Срок оценки: Baseline and post-intervention (up to 6 weeks).]
• 5 Times Sit to Stand [Срок оценки: Baseline and post-intervention (up to 6 weeks).]

Критерии участия

Критерии включения

• Diagnosis of Parkinson's Disease

Критерии исключения

• Inability to stand or walk without an assistive device
• History of symptoms in stance that preclude safe and comfortable participation, such as dizziness and lightheadedness, orthostasis, severe symptomatic leg or back musculoskeletal pain, or medication side effects
• Any other history of medical or psychiatric comorbidity, precluding safe participation in the project.
• History of symptomatic cardiovascular or pulmonary disease
• History of active rheumatic arthritis
• History of stroke or other neurologic conditions with significant residual sensorimotor deficits
• History of disabling chronic pain syndrome requiring narcotic analgesics
• Evidence of dementia (Mini Mental State Exam (or Montreal Cognitive Assessment test) <24 and significant impairment in activities of daily living)
• Venous ulcerative stasis or severe varicosities.
• Pregnancy as determined by urine pregnancy test prior to DXA procedure in women of childbearing potential.

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

Лечение

Центры проведения

США · 1 центр

• Domino's Farms — Ann Arbor

Идентификаторы

NCT: NCT07543861 · HUM00280455

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗