Split-belt Treadmill Training for Freezing of Gait in Parkinson's Disease

Parkinson Disease Clinical Trial

— SBT FOG-TRAIN  

Official title:

Turning Around Freezing: Effect of Split-belt Treadmill Training on Daily-life Turning-related Freezing of Gait in Parkinson's Disease

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05511597
• Other study ID #: S65984
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 16, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Freezing of Gait
• Parkinson Disease

Intervention

Behavioral:
• Split-belt treadmill training
Split-belt walking with various speed ratios between the two legs, applied with random-block practice
• Complex task practice
Overground gait flexibility training with added cognitive tasks
• Static balance exercise
Mindfulness and breathing combined with static balance exercises

Locations

Country	Name	City	State
Belgium	Faculty of Movement and Rehabilitation Sciences (FaBeR)	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
KU Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

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

Outcome

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