A Pilot Study of In-lab Dynamic Standing in Parkinson's Disease (FOGSTAND)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Contact
Study Contact
- Name: Miriam Van Emde Boas, DPT
- Phone Number: 734-936-1174
- Email: bohnenmi@med.umich.edu
Study Contact Backup
- Name: Chatkaew Pongmala, PhD
- Phone Number: 734-936-0111
- Email: pchatkae@med.umich.edu
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48105
- Recruiting
- Domino's Farms
-
Contact:
- Miriam Bohnen, DPT
- Phone Number: 734-936-1174
- Email: bohnenmi@med.umich.edu
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Dynamic Standing Desk in People with Parkinsons
Up to 12 4-hour sessions with the dynamic standing desk completed in the span of 6 weeks.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gait Speed
Time Frame: Baseline and post-intervention (up to 6 weeks).
|
Gait speed will be measured during an 8.5-meter forward walking task measured in meters per second.
|
Baseline and post-intervention (up to 6 weeks).
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III
Time Frame: Baseline and post-intervention (up to 6 weeks).
|
Clinical assessment that measures motor symptoms in Parkinson's Disease.
Higher scores indicates more severe symptoms.
Scores range from 0-132.
|
Baseline and post-intervention (up to 6 weeks).
|
|
Montreal Cognitive Assessment
Time Frame: Baseline and post-intervention (up to 6 weeks).
|
Clinical assessment that measures cognition.
Higher scores indicate better cognition.
Scores range from 0-30.
|
Baseline and post-intervention (up to 6 weeks).
|
|
Timed Up and Go
Time Frame: Baseline and post-intervention (up to 6 weeks).
|
Clinical assessment that measures the time it takes for a participant to stand from a chair, walk 3 meters, turn around, walk back to the chair and sit back down.
Higher time indicates increased motor impairment.
|
Baseline and post-intervention (up to 6 weeks).
|
|
5 Times Sit to Stand
Time Frame: Baseline and post-intervention (up to 6 weeks).
|
Clinical assessment that measures the time it takes for a participant to sit and stand five times.
Higher time indicates increased motor impairment.
|
Baseline and post-intervention (up to 6 weeks).
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Chatkaew Pongmala, PhD, University of Michigan
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- HUM00280455
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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