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Completed

NCT Number: NCT05511597

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

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.

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Key information

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Movement and Rehabilitation Sciences (FaBeR)

Leuven, 3001, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Split-belt treadmill training

Behavioral

Split-belt walking with various speed ratios between the two legs, applied with random-block practice

Complex task practice

Behavioral

Overground gait flexibility training with added cognitive tasks

Static balance exercise

Behavioral

Mindfulness and breathing combined with static balance exercises

Primary outcomes

  1. Percentage Time Frozen during turning in place

    Time frame: 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.

  2. Time to complete Timed Up and Go (TUG)

    Time frame: 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.

Secondary outcomes

  1. Percentage Time Frozen over all FOG-provoking tasks

    Time frame: up to 8 weeks post intervention

    Percentage Time Frozen scored from videos of Turning in place,TUG, Hotspot door and Hotspot personalized.

  2. Percentage Time Frozen over 1-week free-living monitoring

    Time frame: up to 8 weeks post intervention

    Percentage Time Frozen estimated from machine learning algorithm using free-living sensor data captured over 1 week.

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

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

Acronym: SBT FOG-TRAIN

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Aug 23, 2022
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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