Clinical trial NCT05511597: Split-belt Treadmill Training for Freezing of Gait in Parkinson's Disease
Official title: Turning Around Freezing: Effect of Split-belt Treadmill Training on Daily-life Turning-related Freezing of Gait in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Parkinson Disease
Freezing of Gait
Split-belt Treadmill
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2022-08-23
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised single-blind parallel-group study
Primary purpose: TREATMENT

Brief summary: A split-belt treadmill (SBT) is a treadmill with two belts, whereby each leg can be driven at a different speed. Previous work by the investigators showed that one session of SBT training improved turning while multi-tasking and reduced FOG in PwPD tested in the laboratory. However, subsequent work raises questions as to whether treadmill improvements following repeated SBT training generalize to overground situations in the long term. Therefore, in this study, the investigators will perform a four-week SBT intervention with added practice of everyday turning scenarios (SBT+CP) or placebo exercise (SBT+PL), and study its effects on FOG in both the laboratory and at home.


Eligibility criteria: * Be between 40 - 90 years of age
* Have a diagnosis of Parkinson's disease
* Be able to walk for 10 min without an aid
* Be able to follow and understand the oral instructions of the investigator
* Have a disease stage of I to IV (while ON-medication)
* Have had no change in your Parkinson's medication in the past month (or to your deep brain stimulator if applicable) and also no planned changes in medication over the next 4 months
* Have at least about 1 "freezing" episode per day (based on the New Freezing of Gait Questionnaire: N-FOG)
* Not participating in another clinical trial
* Have no acute joint disease
* Not have any other condition that affects your walking pattern or prevents you from completing all study tasks
* Have not undergone major surgery or hospitalization in the last 3 months
* No substance abuse
* No depressive disorder or other apathetic disorder that precludes daily exercise

Primary outcomes:
measure: Percentage Time Frozen during turning in place
timeFrame: up to 8 weeks post intervention
measure: Time to complete Timed Up and Go (TUG)
timeFrame: up to 8 weeks post intervention
Secondary outcomes:
measure: Percentage Time Frozen over all FOG-provoking tasks
timeFrame: up to 8 weeks post intervention
measure: Percentage Time Frozen over 1-week free-living monitoring
timeFrame: up to 8 weeks post intervention
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Faculty of Movement and Rehabilitation Sciences (FaBeR)
Study officials:
affiliation: KU Leuven
name: Alice Nieuwboer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: D'Cruz N, Seuthe J, De Somer C, Hulzinga F, Ginis P, Schlenstedt C, Nieuwboer A. Dual Task Turning in Place: A Reliable, Valid, and Responsive Outcome Measure of Freezing of Gait. Mov Disord. 2022 Feb;37(2):269-278. doi: 10.1002/mds.28887. Epub 2021 Dec 22.
citation: D'Cruz N, Seuthe J, Ginis P, Hulzinga F, Schlenstedt C, Nieuwboer A. Short-Term Effects of Single-Session Split-Belt Treadmill Training on Dual-Task Performance in Parkinson's Disease and Healthy Elderly. Front Neurol. 2020 Sep 30;11:560084. doi: 10.3389/fneur.2020.560084. eCollection 2020.