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

Catholic University (KU) of Leuven

Status: Invitation-only

Conditions: Freezing of Gait; Parkinson Disease; Split-belt Treadmill

Treatments: Behavioral: Complex task practice; Behavioral: Static balance exercise; Behavioral: Split-belt treadmill training

Study type: Interventional

Funder types: Other

Identifiers

NCT05511597

S65984

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

SBT+CP

Experimental group

Description:

Split-belt training + complex task practice

Treatment:

Behavioral: Complex task practice

Behavioral: Split-belt treadmill training

SBT+PL

Active Comparator group

Description:

Split-belt training + static exercise

Treatment:

Behavioral: Static balance exercise

Behavioral: Split-belt treadmill training