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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-16

Study Completion Date

2025-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Parkinson Disease Freezing of Gait Split-belt Treadmill

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised single-blind parallel-group study

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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

Study Groups

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SBT+CP

Split-belt training + complex task practice

Group Type EXPERIMENTAL

Split-belt treadmill training

Intervention Type BEHAVIORAL

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

Complex task practice

Intervention Type BEHAVIORAL

Overground gait flexibility training with added cognitive tasks

SBT+PL

Split-belt training + static exercise

Group Type ACTIVE_COMPARATOR

Split-belt treadmill training

Intervention Type BEHAVIORAL

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

Static balance exercise

Intervention Type BEHAVIORAL

Mindfulness and breathing combined with static balance exercises

Interventions

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Split-belt treadmill training

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

Intervention Type BEHAVIORAL

Complex task practice

Overground gait flexibility training with added cognitive tasks

Intervention Type BEHAVIORAL

Static balance exercise

Mindfulness and breathing combined with static balance exercises

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No