Parkinson Disease Clinical Trial
— SBT FOG-TRAINOfficial title:
Turning Around Freezing: Effect of Split-belt Treadmill Training on Daily-life Turning-related Freezing of Gait in Parkinson's Disease
Verified date | February 2024 |
Source | KU Leuven |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 30 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 90 Years |
Eligibility | - 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Faculty of Movement and Rehabilitation Sciences (FaBeR) | Leuven |
Lead Sponsor | Collaborator |
---|---|
KU Leuven |
Belgium,
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage Time Frozen during turning in place | Percentage Time Frozen scored from video of rapid alternating full turns in place. Based on earlier work showing immediate effects of SBT training on FOG during this task. | up to 8 weeks post intervention | |
Primary | Time to complete Timed Up and Go (TUG) | Overall time to complete the Timed Up and Go task. The training is expected to improve multiple transitions between straight walking and turning and should be reflected in the overall task time. | up to 8 weeks post intervention | |
Secondary | Percentage Time Frozen over all FOG-provoking tasks | Percentage Time Frozen scored from videos of Turning in place,TUG, Hotspot door and Hotspot personalized. | up to 8 weeks post intervention | |
Secondary | Percentage Time Frozen over 1-week free-living monitoring | Percentage Time Frozen estimated from machine learning algorithm using free-living sensor data captured over 1 week. | up to 8 weeks post intervention |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05415774 -
Combined Deep Brain Stimulation in Parkinson's Disease
|
N/A | |
Recruiting |
NCT04691661 -
Safety, Tolerability, Pharmacokinetics and Efficacy Study of Radotinib in Parkinson's Disease
|
Phase 2 | |
Active, not recruiting |
NCT05754086 -
A Multidimensional Study on Articulation Deficits in Parkinsons Disease
|
||
Completed |
NCT04045925 -
Feasibility Study of the Taïso Practice in Parkinson's Disease
|
N/A | |
Recruiting |
NCT04194762 -
PARK-FIT. Treadmill vs Cycling in Parkinson´s Disease. Definition of the Most Effective Model in Gait Reeducation
|
N/A | |
Completed |
NCT02705755 -
TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH)
|
Phase 2 | |
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Recruiting |
NCT05830253 -
Free-living Monitoring of Parkinson's Disease Using Smart Objects
|
||
Recruiting |
NCT03272230 -
Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System
|
N/A | |
Recruiting |
NCT06139965 -
Validity and Reliability of the Turkish Version of the Comprehensive Coordination Scale in Parkinson's Patients
|
||
Completed |
NCT04580849 -
Telerehabilitation Using a Dance Intervention in People With Parkinson's Disease
|
N/A | |
Completed |
NCT04477161 -
Effect of Ketone Esters in Parkinson's Disease
|
N/A | |
Completed |
NCT03980418 -
Evaluation of a Semiconductor Camera for the DaTSCAN™ Exam
|
N/A | |
Completed |
NCT04942392 -
Digital Dance for People With Parkinson's Disease During the COVID-19 Pandemic
|
N/A | |
Terminated |
NCT03446833 -
LFP Beta aDBS Feasibility Study
|
N/A | |
Completed |
NCT03497884 -
Individualized Precise Localization of rTMS on Primary Motor Area
|
N/A | |
Completed |
NCT05538455 -
Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases
|
N/A | |
Recruiting |
NCT04997642 -
Parkinson's Disease and Movement Disorders Clinical Database
|
||
Completed |
NCT04117737 -
A Pilot Study of Virtual Reality and Antigravity Treadmill for Gait Improvement in Parkinson
|
N/A | |
Recruiting |
NCT03618901 -
Rock Steady Boxing vs. Sensory Attention Focused Exercise
|
N/A |