Split-belt Treadmill Training for Freezing of Gait in Parkinson's Disease (SBT FOG-TRAIN)

February 6, 2024 updated by: Alice Nieuwboer, KU Leuven

Turning Around Freezing: Effect of Split-belt Treadmill Training on Daily-life Turning-related 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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3001
        • Faculty of Movement and Rehabilitation Sciences (FaBeR)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SBT+CP
Split-belt training + complex task practice
Behavioral: Split-belt treadmill training
Split-belt walking with various speed ratios between the two legs, applied with random-block practice
Behavioral: Complex task practice
Overground gait flexibility training with added cognitive tasks
Active Comparator: SBT+PL
Split-belt training + static exercise
Behavioral: Split-belt treadmill training
Split-belt walking with various speed ratios between the two legs, applied with random-block practice
Behavioral: Static balance exercise
Mindfulness and breathing combined with static balance exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 8 weeks post intervention
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.
up to 8 weeks post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 8 weeks post intervention
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.
up to 8 weeks post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Investigators

  • Principal Investigator: Alice Nieuwboer, PhD, KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2022

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

August 18, 2022

First Submitted That Met QC Criteria

August 19, 2022

First Posted (Actual)

August 23, 2022

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S65984

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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