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

Not Applicable

• Conditions: Parkinson Disease; Split-belt Treadmill; Freezing of Gait
• Interventions: Behavioral: Split-belt treadmill training; Behavioral: Static balance exercise; Behavioral: Complex task practice

• Registration Number: NCT05511597
• Lead Sponsor: KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-18
• Study First Submitted QC: 2022-08-19
• Study First Posted: 2022-08-23
• Study Start: 2022-12-16
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-06
• Primary Completion: 2025-10-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SBT+PL	Static balance exercise	Split-belt training + static exercise
SBT+PL	Split-belt treadmill training	Split-belt training + static exercise
SBT+CP	Complex task practice	Split-belt training + complex task practice
SBT+CP	Split-belt treadmill training	Split-belt training + complex task practice

Primary Outcome Measures

Name	Time	Method
Time to complete Timed Up and Go (TUG)	up to 8 weeks post intervention	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.
Percentage Time Frozen during turning in place	up to 8 weeks post intervention	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.

Secondary Outcome Measures

Name	Time	Method
Percentage Time Frozen over 1-week free-living monitoring	up to 8 weeks post intervention	Percentage Time Frozen estimated from machine learning algorithm using free-living sensor data captured over 1 week.
Percentage Time Frozen over all FOG-provoking tasks	up to 8 weeks post intervention	Percentage Time Frozen scored from videos of Turning in place,TUG, Hotspot door and Hotspot personalized.

Trial Locations

Locations (1)

Faculty of Movement and Rehabilitation Sciences (FaBeR); 🇧🇪 Leuven, Belgium