Freezing of Gait, Parkinson Disease, Split-belt Treadmill
Conditions
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.
Interventions
BEHAVIORALSplit-belt treadmill training
Split-belt walking with various speed ratios between the two legs, applied with random-block practice
BEHAVIORALComplex task practice
Overground gait flexibility training with added cognitive tasks
BEHAVIORALUpper-limb coordination and power
Dynamic upper-limb mobility, coordination and power exercises with dual-tasking
Sponsors
KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, 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
Intervention model description
Randomised single-blind parallel-group study
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Percentage Time Frozen over 1-week free-living monitoring | up to 8 weeks post intervention | Percentage Time Frozen estimated from FOG-detection algorithm using free-living sensor data captured over 1 week. |
Countries
Belgium
Contacts
PRINCIPAL_INVESTIGATORAlice Nieuwboer, PhD
KU Leuven
Outcome results
None listed