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

Sponsor
KU Leuven (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05511597
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
16.5
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Split-belt treadmill training
  • Behavioral: Complex task practice
  • Behavioral: Static balance exercise
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomised single-blind parallel-group studyRandomised single-blind parallel-group study
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Participants receive training in both arms and will be blinded to the exercise group differences. Outcomes assessor will be blinded to the group allocation and will carry out all assessments in a standardized manner irrespective Investigator will perform blinded analyses of the data
Primary Purpose:
Treatment
Official Title:
Turning Around Freezing: Effect of Split-belt Treadmill Training on Daily-life Turning-related Freezing of Gait in Parkinson's Disease
Anticipated Study Start Date :
Aug 16, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Secondary Outcome Measures

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Movement and Rehabilitation Sciences (FaBeR) Leuven Belgium 3001

Sponsors and Collaborators

  • KU Leuven

Investigators

  • Principal Investigator: Alice Nieuwboer, PhD, KU Leuven

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Alice Nieuwboer, Full Professor, KU Leuven
ClinicalTrials.gov Identifier:
NCT05511597
Other Study ID Numbers:
  • S65984
First Posted:
Aug 23, 2022
Last Update Posted:
Aug 23, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Parkinson Disease

Study Results

No Results Posted as of Aug 23, 2022