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

University of Michigan

Status and phase: Enrolling; Phase 1

Conditions: Parkinson Disease

Treatments: Device: Dynamic Standing Desk

Study type: Interventional

Funder types: Other

Identifiers

NCT07543861

HUM00280455

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 5 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Parkinson's Disease

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Dynamic Standing Desk in People with Parkinsons

Experimental group

Description:

Up to 12 4-hour sessions with the dynamic standing desk completed in the span of 6 weeks.

Treatment:

Device: Dynamic Standing Desk