Back to resultsSplit-belt Treadmill Training for Freezing of Gait in Parkinson's Disease (SBT FOG-TRAIN)
Primary Purpose
Parkinson Disease, Freezing of Gait, Split-belt Treadmill
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Split-belt treadmill training
Complex task practice
Static balance exercise
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility 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
Sites / Locations
- Faculty of Movement and Rehabilitation Sciences (FaBeR)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SBT+CP
SBT+PL
Arm Description
Split-belt training + complex task practice
Split-belt training + static exercise
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Percentage Time Frozen over all FOG-provoking tasks
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
Percentage Time Frozen estimated from machine learning algorithm using free-living sensor data captured over 1 week.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05511597
Brief Title
Split-belt Treadmill Training for Freezing of Gait in Parkinson's Disease
Acronym
SBT FOG-TRAIN
Official Title
Turning Around Freezing: Effect of Split-belt Treadmill Training on Daily-life Turning-related Freezing of Gait in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 16, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Freezing of Gait, Split-belt Treadmill
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised single-blind parallel-group study
Masking
ParticipantInvestigatorOutcomes 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
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SBT+CP
Arm Type
Experimental
Arm Description
Split-belt training + complex task practice
Arm Title
SBT+PL
Arm Type
Active Comparator
Arm Description
Split-belt training + static exercise
Intervention Type
Behavioral
Intervention Name(s)
Split-belt treadmill training
Intervention Description
Split-belt walking with various speed ratios between the two legs, applied with random-block practice
Intervention Type
Behavioral
Intervention Name(s)
Complex task practice
Intervention Description
Overground gait flexibility training with added cognitive tasks
Intervention Type
Behavioral
Intervention Name(s)
Static balance exercise
Intervention Description
Mindfulness and breathing combined with static balance exercises
Primary Outcome Measure Information:
Title
Percentage Time Frozen during turning in place
Description
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 Frame
up to 8 weeks post intervention
Title
Time to complete Timed Up and Go (TUG)
Description
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.
Time Frame
up to 8 weeks post intervention
Secondary Outcome Measure Information:
Title
Percentage Time Frozen over all FOG-provoking tasks
Description
Percentage Time Frozen scored from videos of Turning in place,TUG, Hotspot door and Hotspot personalized.
Time Frame
up to 8 weeks post intervention
Title
Percentage Time Frozen over 1-week free-living monitoring
Description
Percentage Time Frozen estimated from machine learning algorithm using free-living sensor data captured over 1 week.
Time Frame
up to 8 weeks post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice Nieuwboer, PhD
Organizational Affiliation
KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Movement and Rehabilitation Sciences (FaBeR)
City
Leuven
ZIP/Postal Code
3001
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34939224
Citation
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.
Results Reference
background
PubMed Identifier
33101174
Citation
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.
Results Reference
background
Learn more about this trial
Split-belt Treadmill Training for Freezing of Gait in Parkinson's Disease
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