Physical Therapy + Medication for Parkinson's Disease

(TAME-PD Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Hubert Fernandez

Must be taking: Dopaminergic therapy

Must not be taking: MAO inhibitors

Disqualifiers: Atypical parkinsonism, Epilepsy, Cardiac arrhythmia, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{2 6 7 8 9}

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. ^{2 4 6 7 10}

Research Team

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.

Trial 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 (Norepinephrine Reuptake Inhibitor)
• Methylphenidate (Psychostimulant)
• Physical Therapy (Behavioural Intervention)

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

Group I: Physical Therapy Active Control 1 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 Methylphenidate Active Control 2 Interventions

Methylphenidate 20 mg daily in combination with PT

Group III: Physical Therapy plus Atomoxetine Active Control 2 Interventions

Atomoxetine 10 mg daily in combination with PT or PT alone.

Who Is Running the Clinical Trial?

Hubert Fernandez

Lead Sponsor

Trials

1

Recruited

40+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of physical therapy in Parkinson's disease: a research synthesis. de Goede, CJ., Keus, SH., Kwakkel, G., et al.[2019]

A four-month physical therapy program combined with drug therapy significantly improved clinical ratings and motor performance in Parkinson's patients compared to those receiving drug therapy alone.

Improvements were observed across various severity levels of symptoms and disease durations, suggesting that physical therapy is beneficial for a wide range of patients with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation and Parkinson's disease. Formisano, R., Pratesi, L., Modarelli, FT., et al.[2008]

A 20-week physical therapy program significantly improved disability and motor skills in 20 patients with Parkinson's disease, as measured by various scales including UPDRS and the Ten-Meter Walk test.

Improvements in motor function and quality of life were largely maintained even 3 months after the completion of the rehabilitation program, indicating the long-term benefits of sustained physical therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical therapy in Parkinson's disease: an open long-term rehabilitation trial. Pellecchia, MT., Grasso, A., Biancardi, LG., et al.[2022]

The proactive physical therapy (PAPT) program for people with Parkinson disease (PD) was successfully implemented at a rehabilitation center, targeting individuals before significant mobility issues arose, and resulted in a doubling of participants engaging in regular exercise over six months.

Participants in the PAPT program reported substantial physical and emotional benefits, with a notable increase in aerobic exercise participation and balance activities, highlighting the program's effectiveness in promoting long-term independent exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Implementation Frameworks to Provide Proactive Physical Therapy for People With Parkinson Disease: Case Report. Rafferty, MR., MacDonald, J., Byskosh, A., et al.[2020]

Current medical treatments for Parkinson's disease are only partially effective, highlighting the need for additional support through physical and occupational therapy.

This review emphasizes the importance of a multidisciplinary approach, detailing how physical and occupational therapists can uniquely and collaboratively help patients manage daily activities and overcome challenges related to their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical therapy and occupational therapy in Parkinson's disease. Radder, DLM., Sturkenboom, IH., van Nimwegen, M., et al.[2018]

Early and continuous rehabilitation, combined with appropriate medication, is crucial for improving the quality of life in patients with Parkinson's disease, as it promotes self-awareness and the importance of daily physical activity.

Rehabilitation is cost-effective, has no adverse effects, and can be performed at home, making it a vital component in preventing disability and enhancing patients' overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Rehabilitation of patients with Parkinson disease]. Kwolek, A.[2015]

A large study involving 762 patients with mild to moderate Parkinson's disease found that individualized physiotherapy and occupational therapy did not lead to significant improvements in activities of daily living or quality of life compared to no therapy.

While there were slight improvements in health-related quality of life measures, these were not clinically meaningful, suggesting that current low-dose, patient-centered therapy approaches may not be effective for early-stage Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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). Clarke, CE., Patel, S., Ives, N., et al.[2022]

References

1. France pubmed.ncbi.nlm.nih.gov

[Exercices program and rehabilitation of motor disorders in Parkinson's disease]. [2006]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of Exercise and Rehabilitation Therapy on Risk of Hospitalization in Parkinson's Disease. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

The effects of physical therapy in Parkinson's disease: a research synthesis. [2019]

4. Sweden pubmed.ncbi.nlm.nih.gov

Rehabilitation and Parkinson's disease. [2008]

5. Germany pubmed.ncbi.nlm.nih.gov

Physical therapy in Parkinson's disease: an open long-term rehabilitation trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Using Implementation Frameworks to Provide Proactive Physical Therapy for People With Parkinson Disease: Case Report. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Physical therapy and occupational therapy in Parkinson's disease. [2018]

8. Poland pubmed.ncbi.nlm.nih.gov

[Rehabilitation of patients with Parkinson disease]. [2015]

9. England pubmed.ncbi.nlm.nih.gov

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 States pubmed.ncbi.nlm.nih.gov

Evidence for Early and Regular Physical Therapy and Exercise in Parkinson's Disease. [2022]