Improving Gait and Balance in Parkinson's Disease with Therapy and Medications
TAME-PD - Physical Therapy, Atomoxetine And, Methylphenidate, to Enhance Gait and Balance in Parkinson's Disease: a Single Center, Randomized Pilot Study
EARLY_PHASE1 · The Cleveland Clinic · NCT02879136
This study is testing if combining physical therapy with two medications can help people with Parkinson's disease improve their walking and balance better than just physical therapy alone.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | The Cleveland Clinic (other) |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT02879136 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effects of combining physical therapy with two medications, methylphenidate and atomoxetine, on gait and balance in patients with Parkinson's Disease. It aims to determine if this combination leads to greater improvements compared to physical therapy alone. The study is designed as a pilot, single-center, rater-blind, prospective randomized trial with two parallel groups. Participants will be assessed using the Unified Parkinson Disease Rating Scale to evaluate their gait and balance improvements.
Who should consider this trial
Good fit: Ideal candidates are patients with Parkinson's Disease experiencing significant gait or balance disorders despite stable dopaminergic therapy.
Not a fit: Patients with atypical parkinsonism or those with comorbidities that contraindicate the use of the study medications may not benefit from this trial.
Why it matters
Potential benefit: If successful, this approach could significantly enhance mobility and reduce fall risk for patients with Parkinson's Disease.
How similar studies have performed: Previous studies have shown promising results for methylphenidate in improving gait in Parkinson's Disease, suggesting potential success for this combined approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with PD having significant balance or gait disorder with a score ≥2 in the Unified Parkinson Disease Rating Scale (UPDRS) 3.10 item 'independent walking but with substantial gait impairment; not related to off periods' occurring despite satisfactory motor control by dopaminergic therapy, with a medication regimen unlikely to change in the next 30 days. Exclusion Criteria: * Previous participation in PD-specific PT. * Presence of signs and symptoms suggestive of atypical parkinsonism. * Concomitant conditions that may affect significantly the evaluation of balance or gait, including orthopedic, rheumatologic or other neurological diseases. * Contraindication for physical therapy * Comorbidities that contraindicate the use of the methylphenidate or atomoxetine: history of substance abuse, current severe anxiety, depression or psychosis, epilepsy, hyperthyroidism, glaucoma, cardiac arrhythmia, history of Tourette syndrome, hepatic disease, allergy to methylphenidate or atomoxetine. * Concurrent use of MAO inhibitors, or use in the last two weeks. * Previous deep brain stimulation procedure. * Punctuation of 5 in Hoehn and Yard modified scale: 'Wheelchair bound or bedridden unless aided'.
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic — Cleveland, Ohio, United States (RECRUITING)
Study contacts
- Study coordinator: Jennifer Mule, B.S. Biology
- Email: mulej@ccf.org
- Phone: 216 444 1134
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Parkinson's Disease, Idiopathic, Gait, Balance, PD