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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special kind of treadmill training, known as split-belt treadmill training, to help people with Parkinson's disease improve their walking and balance. The goal is to reduce issues like freezing of gait, where individuals suddenly can't walk, potentially leading to falls and a lower quality of life. Participants will walk on a treadmill with either both belts moving at the same speed or one belt moving slower to encourage better walking patterns. The trial seeks individuals who have had Parkinson's disease for 5 to 15 years, experience freezing of gait, and can walk on a treadmill.

As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance mobility and quality of life for those with Parkinson's disease.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, it mentions that participants should have a stable response to their medications for at least 3 months before joining.

What prior data suggests that split-belt treadmill training is safe for Parkinson's disease patients?

Research has shown that split-belt treadmill training is generally well-tolerated by people with Parkinson's disease. Studies have found that this training can improve walking by balancing the movement of both legs. While the effects on walking are promising, specific safety data for Parkinson's remains limited.

The treadmill's inclusion in research suggests it is considered safe enough for study. This type of training has been used in other contexts to aid walking, with no reports of serious side effects. Some individuals might experience fatigue or mild discomfort, but adjustments can typically be made to accommodate each person's needs.

Overall, despite limited detailed safety data, existing research supports split-belt treadmill training as a safe option for addressing walking issues in Parkinson's. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about split-belt treadmill training for Parkinson's disease because it offers a unique approach to improving gait and balance, which are common challenges for individuals with this condition. Unlike standard treatments like medication (e.g., Levodopa) or traditional physical therapy, this method specifically targets the asymmetry in walking by adjusting the treadmill speed for each leg. By training the brain to adapt to these new walking patterns, it could potentially enhance mobility and reduce fall risk. This innovative strategy focuses on retraining the motor system, offering hope for more effective management of Parkinson's symptoms.

What evidence suggests that split-belt treadmill training is effective for Parkinson's disease?

Research has shown that split-belt treadmill (SBT) training, which participants in this trial may receive, can improve walking in people with Parkinson's disease. Studies have found that SBT training leads to better adjustments in walking patterns, with moderate to large improvements compared to regular treadmill training. These improvements are crucial, particularly in reducing differences between the movements of each leg, a common issue in Parkinson's. SBT training allows each leg to walk at its own speed, helping individuals adjust to and recover from an uneven walking pattern. Early results suggest that this method can effectively manage walking issues, including "freezing of gait," when someone suddenly cannot move their feet forward. ^{1 2 3 6 7}

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

MMSE >24/30

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

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

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32940131/

The Effect of One Session Split-Belt Treadmill Training on ... Results: SBT proved beneficial for gait adaptation in PD + FOG and HC (P < . 0001); however, HC improved more.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36239376/

Split-Belt Treadmill Training to Improve Gait Adaptation in ... Results: We found that SBT-training improved gait adaptation with moderate to large effects sizes (P < 0.02) compared to TBT, effects that were ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04946812

Split-belt Treadmill Training to Rehabilitate Freezing of Gait ... It can be used to target specific gait deviations, and preliminary research has indicated that it can improve gait disorders in PD by decreasing limb asymmetry.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0966636218318198

Split-belt treadmill walking in patients with Parkinson's ... Walking on a split-belt treadmill (SBT) can help to modulate an asymmetric gait, particularly for people with neurological conditions, such as Parkinson's ...

5. movementdisorders.onlinelibrary.wiley.com movementdisorders.onlinelibrary.wiley.com/doi/10.1002/mds.29238

Split‐Belt Treadmill Training to Improve Gait Adaptation in ... We found that SBT-training improved gait adaptation with moderate to large effects sizes (P < 0.02) compared to TBT, effects that were sustained ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40755229/

Split-Belt Treadmill for Falls, Gait Asymmetry, and Freezing ... Split-Belt Treadmill for Falls, Gait Asymmetry, and Freezing in Parkinson's ... Primary outcome was the incidence of falls 3 months after training ...

7. nature.com nature.com/articles/s41598-025-98322-3

Split-belt treadmill training improves gait symmetry and ... A 4-week SBTT intervention could effectively improve gait asymmetry and, consequently, enhance walking and lower limb function in PwS with independent walking ...