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)

Trial Summary

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 data supports the effectiveness of the treatment TURN-IT FOG for freezing of gait in Parkinson's disease?

Research shows that overground robot-assisted gait training, which is similar to TURN-IT FOG, improved walking ability and reduced freezing episodes in Parkinson's patients who did not respond to medication. This suggests that TURN-IT FOG might also help improve walking in these patients.12345

Is the TURN-IT FOG treatment safe for humans?

A pilot study on a community-based group intervention for freezing of gait in Parkinson's disease found it to be safe, suggesting that similar rehabilitation approaches like TURN-IT FOG may also be safe for humans.24678

How is the TURN-IT FOG treatment different from other treatments for freezing of gait in Parkinson's disease?

The TURN-IT FOG treatment is unique because it focuses on rehabilitation approaches specifically designed to address freezing of gait in Parkinson's disease, which may not respond well to medications. Unlike other treatments, it may incorporate action observation strategies to enhance physical training, potentially offering a novel way to improve gait control and reduce freezing episodes.245910

What is the purpose of this trial?

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 Parkinson's disease, as assessed by patients, clinicians, and wearable sensors, and 2) to explore whether two different rehabilitation intervention can reduce FOG and improve daily life mobility in people with FOG sufficiently to justify a clinical trial.Participants will:* Be randomly assigned to one of two intervention groups (turning-focused agility exercise or strength-based exercise)* Have one-on-one training sessions three times per week for 6 weeks* Perform in-lab assessments before beginning and after completing the study intervention* Use wearable mobility sensors during daily life to measure their walking and balance

Research Team

MM

Martina Mancini, PhD

Principal Investigator

Oregon Health and Science University

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental intervention groupExperimental Treatment1 Intervention
Specific participant procedures in experimental and active control interventions are simplified to preserve study blinding.
Group II: Active intervention groupActive Control1 Intervention
Specific participant procedures in experimental and active control interventions are simplified to preserve study blinding.

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+

Findings from Research

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]

References

Evaluation of physical therapy in parkinsonian patients with freezing of gait: a pilot study. [2017]
Multitarget Transcranial Electrical Stimulation for Freezing of Gait: A Randomized Controlled Trial. [2022]
Overground robot assisted gait trainer for the treatment of drug-resistant freezing of gait in Parkinson disease. [2022]
The effect of rehabilitation interventions on freezing of gait in people with Parkinson's disease is unclear: a systematic review and meta-analyses. [2023]
Action observation improves freezing of gait in patients with Parkinson's disease. [2022]
Future Therapeutic Strategies for Freezing of Gait in Parkinson's Disease. [2021]
A Randomized Controlled Feasibility Trial of a Specific Cueing Program for Falls Management in Persons With Parkinson Disease and Freezing of Gait. [2015]
Freezing of Gait Boot Camp: feasibility, safety and preliminary efficacy of a community-based group intervention. [2023]
FoG-Finder: Real-time Freezing of Gait Detection and Treatment. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Is freezing of gait in Parkinson's disease a result of multiple gait impairments? Implications for treatment. [2022]
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