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

NCT05511597 | Completed DMC

• 1 other identifier: S65984
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Freezing of Gait; Split-belt Treadmill

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Percentage Time Frozen over all FOG-provoking tasks

  up to 8 weeks post intervention

• Percentage Time Frozen over 1-week free-living monitoring

  up to 8 weeks post intervention

Study Arms (2)

SBT+CP

EXPERIMENTAL

Split-belt training + complex task practice

Behavioral: Split-belt treadmill training; Behavioral: Complex task practice

SBT+PL

ACTIVE COMPARATOR

Split-belt training + static exercise

Behavioral: Split-belt treadmill training; Behavioral: Static balance exercise

Interventions

Split-belt treadmill training BEHAVIORAL

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

SBT+CP; SBT+PL

Complex task practice BEHAVIORAL

Overground gait flexibility training with added cognitive tasks

SBT+CP

Static balance exercise BEHAVIORAL

Mindfulness and breathing combined with static balance exercises

SBT+PL

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

Faculty of Movement and Rehabilitation Sciences (FaBeR)

Leuven, 3001, Belgium

Location

Related 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.

  PMID: 34939224 BACKGROUND

• 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.

  PMID: 33101174 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Alice Nieuwboer, PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: Randomised single-blind parallel-group study

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 23, 2022
• Study Start: December 16, 2022
• Primary Completion: October 31, 2025
• Study Completion: March 17, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)