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Treadmill Training for Parkinson's Disease
N/A
Waitlist Available
Research Sponsored by University of Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Hoehn & Yahr Stage 2-3, on levodopa
FOG, resistant to dopaminergic therapy
Must not have
Cardiac conditions limiting the ability to walk uninterrupted for 1 hour
Severe imbalance that limits ambulation (Hoehn &Yahr score above 3)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Awards & highlights
No Placebo-Only Group
Summary
This trial uses a special treadmill with two belts moving at different speeds to help people with Parkinson's disease improve their walking. It targets those who have trouble walking evenly and often freeze while walking. The treadmill helps them learn to walk more symmetrically, which can reduce falls and improve their quality of life.
Who is the study for?
This trial is for people with Parkinson's Disease who have trouble walking or freezing when they try to walk (FOG). They should be in the middle stages of the disease, able to take levodopa, and not have had changes in their medication or deep brain stimulation settings for at least 3 months. Participants need a certain level of mental sharpness and must be able to use a treadmill.
What is being tested?
The study tests split-belt treadmill training on patients with Parkinson's. This type of treadmill can move each belt at different speeds, which may help improve walking symmetry and coordination by teaching the legs how to adapt to an uneven gait then readjust back.
What are the potential side effects?
While this document doesn't list specific side effects, exercise interventions like split-belt treadmill training could potentially cause muscle soreness, fatigue, joint stress or increase fall risk during adaptation phases.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am in the middle stages of Parkinson's and take levodopa.
Select...
My walking is impaired and not improving with Parkinson's medication.
Select...
I have been diagnosed with Parkinson's disease of unknown cause.
Select...
I can walk on a treadmill.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot walk for an hour without stopping due to heart problems.
Select...
I have severe difficulty walking due to my condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~obtained at baseline evaluation, after 1.5 months of training, and 3-months post intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Falls
Secondary study objectives
Balance and postural stability
Freezing of gait
Gait
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention groupExperimental Treatment1 Intervention
The velocity of the belt will be adjusted to the over-ground speed of the subject, and will be reduced on the least affected side by 25%. While the speed of the treadmill will not change throughout the study, the duration of the training will increase each week. In the first week, the SBTM training will take place for 10 minutes. There will be a 5-minute rest period, and the split-belt conditions will continue for another 10 minutes of training (total training time= 20 minutes).
Group II: Control groupActive Control1 Intervention
The subject will continue to walk under tied-belt conditions adjusted to the over-ground walking speed. In the first week, the treadmill training will be for 10 minutes. They will get a 5-minute break, similar to the intervention group, and continue for another 10 minutes under tied-belt conditions.
The duration of each session will increase by 8 minutes every week. For example, in week 1, the treadmill training will be for a total of 20 minutes; in week 2, for 28 minutes; in week 3, for 36 minutes, and so forth, until it gets to 60 minutes by week 6. The rest period will remain at 5 minutes each session, and will always take place at the halfway mark. All 3 sessions in the week will have the same duration of training.
If the subject cannot tolerate the velocity or duration of the session, the protocol will be adjusted to most recently tolerated session (and will be recorded for further interpretation and analysis).
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Who is running the clinical trial?
University of TorontoLead Sponsor
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1,022,794 Total Patients Enrolled
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