42 Participants Needed

Physical Therapy + Medication for Parkinson's Disease

(TAME-PD Trial)

SP
JM
JM
Overseen ByJennifer Mule, B.S. Biology
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Hubert Fernandez
Must be taking: Dopaminergic therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it mentions that your medication regimen should be stable and unlikely to change in the next 30 days. If you are using MAO inhibitors, you must stop them at least two weeks before joining the trial.

What data supports the effectiveness of physical therapy combined with medication for Parkinson's disease?

Research shows that combining physical therapy with medication can improve motor skills and daily life activities in Parkinson's patients. Studies found that physical therapy helps with walking, balance, and reducing disability, especially when used alongside drug treatments.12345

Is physical therapy safe for people with Parkinson's disease?

Physical therapy is generally considered safe for people with Parkinson's disease and can improve their quality of life. It has no adverse effects and can be done at home, making it a beneficial part of treatment without the risks associated with some medications.26789

How does the treatment of Physical Therapy + Medication for Parkinson's Disease differ from other treatments?

This treatment is unique because it combines physical therapy with medication, aiming to improve motor function and quality of life by addressing both physical and chemical aspects of Parkinson's disease. Physical therapy focuses on exercises for balance, posture, and mobility, which can enhance the effectiveness of medication and provide a more comprehensive approach to managing symptoms.246710

What is the purpose of this trial?

Gait and balance problems are a significant source of disability in patients with Parkinson disease. Physical therapy remains one of the main treatments. On the other hand some medications, such as methyphenidate and atomoxetine, have been tried with promising results. The outcomes in gait and balance in Parkinson disease after a combination of physical therapy and the medications mentioned above have not been explored yet. The investigators want to evaluate whether the addition of medication, either low dose of methylphenidate or atomoxetine, to physical therapy will achieve improvement in gait and balance in Parkinson disease more than physical therapy alone. The investigators propose a pilot, single center, rater blind, prospective randomized trial. 2-arm-parallel group, intention-to-treat analysis.

Research Team

HF

Hubert Fernandez

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

This trial is for Parkinson's disease patients with significant gait and balance issues, despite stable dopaminergic therapy. They must score ≥2 on the UPDRS item for walking impairment. Exclusions include severe mental health issues, epilepsy, heart problems, glaucoma, liver disease, allergies to study drugs, wheelchair dependence or bedridden state without help.

Inclusion Criteria

I have Parkinson's with major walking issues despite medication, not expected to change my meds soon.

Exclusion Criteria

I don't have conditions that majorly affect my walking or balance.
Previous deep brain stimulation procedure
I need help to move from a wheelchair or bed.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive physical therapy sessions twice weekly for 12 weeks, with or without the addition of methylphenidate or atomoxetine

12 weeks
24 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Atomoxetine
  • Methylphenidate
  • Physical Therapy
Trial Overview The TAME-PD trial is testing if adding low doses of either methylphenidate or atomoxetine to physical therapy can improve gait and balance in Parkinson's patients more than physical therapy alone. It's a pilot study where participants are randomly assigned to one of two groups in a blinded fashion.
Participant Groups
3Treatment groups
Active Control
Group I: Physical TherapyActive Control1 Intervention
Physical Therapy (PT) will consist of two weekly sessions over a 12 week period using the Mellen center protocol PT for PD.
Group II: Physical Therapy plus MethylphenidateActive Control2 Interventions
Methylphenidate 20 mg daily in combination with PT
Group III: Physical Therapy plus AtomoxetineActive Control2 Interventions
Atomoxetine 10 mg daily in combination with PT or PT alone.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hubert Fernandez

Lead Sponsor

Trials
1
Recruited
40+

Findings from Research

Exercise and rehabilitation programs become essential for Parkinson's disease patients when motor decline occurs despite DOPAtherapy, as they can help reduce daily life disability rather than directly improving core symptoms like bradykinesia or tremor.
Only a few well-designed studies exist on the effectiveness of rehabilitation in Parkinson's disease, but they suggest that early intervention with physiotherapy focusing on postural control and fall prevention can significantly benefit patients' independence.
[Exercices program and rehabilitation of motor disorders in Parkinson's disease].Pélissier, J., Pérennou, D.[2006]
Longitudinal analysis of data from 4674 individuals with Parkinson's disease showed that greater duration and intensity of exercise are linked to a lower risk of hospitalization.
In contrast, increased use of physical therapy (PT) and occupational therapy was associated with a higher likelihood of hospital encounters, suggesting that while PT may help identify at-risk patients, it does not prevent hospitalizations.
Effect of Exercise and Rehabilitation Therapy on Risk of Hospitalization in Parkinson's Disease.Kannarkat, GT., Rafferty, MR., Luo, S., et al.[2023]
Physical therapy (PT) significantly improves activities of daily living (ADLs) and stride length in patients with Parkinson's disease, with effect sizes of 0.40 and 0.46 respectively, based on a meta-analysis of studies published up to 1999.
While PT shows promise in enhancing walking speed (effect size of 0.49), the results are more variable, and neurologic signs did not show significant improvement, indicating that while PT is beneficial, its effects can vary among different aspects of Parkinson's disease.
The effects of physical therapy in Parkinson's disease: a research synthesis.de Goede, CJ., Keus, SH., Kwakkel, G., et al.[2019]

References

[Exercices program and rehabilitation of motor disorders in Parkinson's disease]. [2006]
Effect of Exercise and Rehabilitation Therapy on Risk of Hospitalization in Parkinson's Disease. [2023]
The effects of physical therapy in Parkinson's disease: a research synthesis. [2019]
Rehabilitation and Parkinson's disease. [2008]
Physical therapy in Parkinson's disease: an open long-term rehabilitation trial. [2022]
Using Implementation Frameworks to Provide Proactive Physical Therapy for People With Parkinson Disease: Case Report. [2020]
Physical therapy and occupational therapy in Parkinson's disease. [2018]
[Rehabilitation of patients with Parkinson disease]. [2015]
Clinical effectiveness and cost-effectiveness of physiotherapy and occupational therapy versus no therapy in mild to moderate Parkinson's disease: a large pragmatic randomised controlled trial (PD REHAB). [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Evidence for Early and Regular Physical Therapy and Exercise in Parkinson's Disease. [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security