Treadmill Training for Parkinson's Disease

Overseen By Sanskriti Sasikumar, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Toronto

Must be taking: Levodopa

Disqualifiers: Severe imbalance, Orthopedic conditions, Cardiac conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

28 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am in the middle stages of Parkinson's and take levodopa.

My walking is impaired and not improving with Parkinson's medication.

MMSE >24/30

Exclusion Criteria

You have another neurological condition.

You are unable to speak English fluently.

I cannot walk for an hour without stopping due to heart problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo split-belt treadmill training to rehabilitate gait and balance in Parkinson's Disease

6 weeks

3 sessions per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Split-belt treadmill training

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention group Experimental Treatment 1 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 group Active Control 1 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).

Split-belt treadmill training is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Split-belt treadmill training for:

• Rehabilitation of gait asymmetry in post-stroke hemiparesis

Approved in European Union as Split-belt treadmill therapy for:

• Gait rehabilitation in stroke survivors
• Improvement of step length symmetry in post-stroke hemiparesis

Approved in Canada as Split-belt treadmill training for:

• Rehabilitation of gait disorders in post-stroke patients

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+