60 Participants Needed

Rehabilitation Approaches for Freezing of Gait in Parkinson's Disease

Recruiting at 2 trial locations
GR
Overseen ByGraham R Harker, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Oregon Health and Science University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how two different exercise programs can help people with Parkinson's disease who experience Freezing of Gait (FOG), a condition where walking suddenly stops. Participants will join one of two groups to try either agility-focused exercises or strength-focused exercises. The goal is to identify which program better improves walking and balance in daily life. Individuals with Parkinson's who frequently experience sudden stops while walking might be well-suited for this study. The trial will use the TURN-IT FOG approach, specifically designed to address these challenges. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance daily living for those with Parkinson's.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those who have had a recent change in medication. It's best to discuss your specific situation with the trial coordinators.

What prior data suggests that these rehabilitation interventions are safe for people with Parkinson's disease?

Research has shown that exercise programs like those in this trial are generally safe for people with Parkinson's disease. These exercises aim to improve movement and balance, which are crucial for managing symptoms such as difficulty walking. The activities typically help strengthen muscles and enhance coordination, reducing the risk of falling.

Although specific data for these exact exercises is not available, similar exercise programs have been used successfully in other settings. Participants often experience only minor side effects, such as muscle soreness or tiredness, which are common when starting any new physical activity. These mild effects usually decrease as the body adapts to the exercises.

In summary, exercise programs for Parkinson's disease are known to be safe. They are generally well-tolerated, with most people experiencing only minor and temporary discomfort.12345

Why are researchers excited about this trial?

Researchers are excited about TURN-IT FOG because it offers a fresh approach to addressing freezing of gait in Parkinson's disease through targeted exercise interventions. Unlike standard treatments like medication and deep brain stimulation, which often focus on managing symptoms or altering brain activity, this trial explores dynamic balance and strength training exercises to directly enhance gait stability. By potentially improving movement control and balance through physical rehabilitation, TURN-IT FOG aims to provide a non-invasive, drug-free option that could complement existing therapies and offer new hope for patients struggling with mobility issues.

What evidence suggests that this trial's rehabilitation interventions could be effective for reducing Freezing of Gait in Parkinson's disease?

Research shows that exercises focused on turning can effectively help people with Parkinson's disease who experience Freezing of Gait (FOG). Studies have found that turning commonly triggers FOG, affecting nearly 28% of patients during these movements. In this trial, participants in the dynamic balance exercise intervention group will work on agility and balance, potentially improving their ability to move without freezing. Meanwhile, those in the strength training exercise intervention group will focus on overall walking problems, which can reduce FOG episodes. While both types of exercises offer benefits, targeting specific triggers like turning might provide more targeted results for those dealing with FOG.13678

Who Is on the Research Team?

MM

Martina Mancini, PhD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This trial is for people aged 50-80 with Parkinson's Disease who experience Freezing of Gait, can follow directions, and are able to stand and walk without help. They should be in moderate stages of the disease (stages II-IV) and able to commit to a 6-week exercise program. Those with severe cognitive issues or other health problems affecting gait, recent medication changes, or unable to do moderate exercise cannot join.

Inclusion Criteria

Reporting FOG in the New Freezing of Gait questionnaire (N-FOGQ)
I have Parkinson's diagnosed by a specialist, with symptoms like slow movement, tremor, stiffness, or balance issues not caused by other conditions.
I can follow instructions for tests and exercise classes.
See 3 more

Exclusion Criteria

Excessive use of alcohol or recreational drugs
I may have difficulty understanding or following instructions.
I do not have major health issues affecting my movement other than Parkinson's.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to one of two intervention groups and have one-on-one training sessions three times per week for 6 weeks

6 weeks
18 visits (in-person)

Follow-up

Participants perform in-lab assessments before beginning and after completing the study intervention and use wearable mobility sensors during daily life to measure their walking and balance

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • TURN-IT FOG
Trial Overview The study tests two rehabilitation methods aimed at reducing Freezing of Gait in Parkinson's patients: one focuses on turning agility exercises while the other on strength-based exercises. Participants will train three times weekly for six weeks and wear sensors that track walking and balance.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Dynamic balance exercise intervention groupExperimental Treatment1 Intervention
Group II: Strength training exercise intervention groupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials
1,024
Recruited
7,420,000+

Michael J. Fox Foundation for Parkinson's Research

Collaborator

Trials
117
Recruited
537,000+

Published Research Related to This Trial

In a study involving 20 patients with Parkinson's disease, those who engaged in action observation (watching videos of movements to overcome freezing of gait) showed a significant reduction in FOG episodes at follow-up, compared to those who watched static landscape videos.
Both groups experienced improvements in motor performance and quality of life after physical therapy, but the action observation group had additional benefits, suggesting that combining observation with physical training could enhance rehabilitation for freezing of gait.
Action observation improves freezing of gait in patients with Parkinson's disease.Pelosin, E., Avanzino, L., Bove, M., et al.[2022]

Citations

TURN-IT FOG: Improving Turning and Freezing of Gait in ...The goals of this clinical trial are to 1) learn how two different rehabilitation interventions for PD can reduce Freezing of Gait (FOG) in people with ...
insights from phase-specific cortico-subthalamic dynamicsFreezing of gait (FOG), particularly during turning, is common in Parkinson's disease (PD), but its phase-specific neural mechanisms remain ...
Which Gait Tasks Produce Reliable Outcome Measures of ...Measurement of freezing of gait (FOG) relies on the sensitivity and reliability of tasks to provoke FOG. It is currently unclear which tasks provide the best ...
Triggers for freezing of gait in individuals with Parkinson's ...Turning (28%) appears to be the most effective trigger for eliciting FOG in PwPD, followed by walking through a doorway (14%) and dual tasking (10%).
Multimodal Data for the Detection of Freezing of Gait in ...Freezing of gaits (FOG) is a very disabling symptom of Parkinson's Disease (PD), affecting about 50% of PD patients and 80% of advanced PD ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/39121137/
Which Gait Tasks Produce Reliable Outcome Measures of ...This protocol triggered freezing in all patients in OFF and 91.9% in ON and did so reliably in 95.8% (OFF) and 84.0% (ON) of the sample. We recommend to measure ...
7.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/39845938/
Is the freezing index a valid outcome to assess ...This study aimed to evaluate the FOG-index's classification performance and criterion validity to assess FOG severity during 360 turn.
Developing Outcome Measures for Assessing Freezing of ...The goals of this multi-center study are to validate the new ClinRO for FOG and to further develop a new PRO to enable meaningful advances in treatment ...
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