Neurophysiology of Locomotor Adaptation and Freezing of Gait in Parkinson's Disease
2 other identifiers
interventional
60
1 country
1
Brief Summary
Locomotor adaptation will be studied using an established split-belt treadmill paradigm, consisting of baseline (1:1 speed ratio), split-belt adaptation (2:1) and post-adaptation (1:1) walking. Split-belt walking will be performed under DBS ON and DBS OFF conditions, while off-medication.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable parkinson-disease
Started Aug 2025
Longer than P75 for not_applicable parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2025
CompletedFirst Posted
Study publicly available on registry
April 4, 2025
CompletedStudy Start
First participant enrolled
August 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
August 27, 2025
August 1, 2025
3.4 years
March 28, 2025
August 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Step length rate of adaptation
The rate of adaptation in step length asymmetry is estimated by fitting an exponential decay function to step length asymmetry over the first 100 strides in adaptation.
1 hour
Step length magnitude of adaptation
The magnitude of adaptation in step length asymmetry is estimated by fitting an exponential decay function to step length asymmetry over the first 100 strides in adaptation.
1 hour
Step length after-effects
The after-effect in step length asymmetry is calculated as the mean difference in step length asymmetry between the last 5 strides of baseline and the first 5 series of post-adaptation.
1 hour
Study Arms (2)
DBS ON
ACTIVE COMPARATORDBS will be turned on
DBS OFF
NO INTERVENTIONDBS will be turned off
Interventions
Patients will receive DBS in the clinically-optimized setting.
Eligibility Criteria
You may qualify if:
- consensus diagnosis of idiopathic PD by fellowship trained movement disorders neurologists at the Normal Fixel Institute of Neurological Diseases;
- chronically stable DBS, defined as having had DBS for at least 6 months in duration with optimized DBS settings;
- Age between 18 - 80 years old per the FDA data sheet for PD DBS;
- no dementia according to the clinical diagnostic criteria for PD dementia;
- ambulatory without the use of walking aids, or another person's assistance.
You may not qualify if:
- other previous neurological surgery;
- suspicion of other neurologic diagnoses such as atypical parkinsonism, or Alzheimer's disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Floridalead
- National Institute on Aging (NIA)collaborator
Study Sites (1)
University of Florida
Gainesville, Florida, 32611, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2025
First Posted
April 4, 2025
Study Start
August 1, 2025
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
August 27, 2025
Record last verified: 2025-08