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Music Therapy for Parkinson's Disease (Amped-PD Trial)
Amped-PD Trial Summary
This trial will test whether a new digital therapeutic that uses music to deliver rhythmic auditory stimulation is more effective than a standard walking program in improving physical activity and motor deficits related to quality of walking in people with mild-to-moderate Parkinson's disease.
Amped-PD Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Amped-PD Trial Design
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Who is running the clinical trial?
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- You have major hearing problems.You are currently receiving physical therapy.You have been diagnosed with atypical Parkinsonism.You are at stage 4 or 5 of the Hoehn and Yahr scale for Parkinson's disease.You have fallen more than once in the past 3 months.You are not able to walk by yourself at a comfortable speed of at least 0.4 meters per second.You have a heart condition that may make it unsafe for you to do physical activity.You have bone or joint problems that could make it unsafe for you to do exercise.You are between 40 and 85 years old.You can walk by yourself for at least 10 minutes without help or using a walking aid.You have trouble with memory and thinking, as measured by a test called the Mini-Mental State Exam, and your score is less than 24.You walk for at least 30 minutes, 3 times a week.You have been diagnosed with typical Parkinson's disease by a doctor.You have been diagnosed with stages 1 to 3 of the Modified Hoehn and Yahr scale by a licensed physical therapist.You are younger than 40 years old.You regularly have trouble moving your legs smoothly when walking.You live in a community, not in a facility.
- Group 1: Amped-PD
- Group 2: Active-Control
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is the age range for this research project limited to individuals above twenty years of age?
"Adhering to the participation requirements of this clinical trial, the minimum age for enrolment is 40 years old and upper limit is 80."
Is this clinical investigation actively recruiting test subjects?
"Clinicialtrials.gov confirms that this medical study is still recruiting patients, after debuting on August 1st 2022 and receiving an update on September 19th 2022."
What qualifications do participants need to fulfill in order to be accepted into this trial?
"This medical trial is currently recruiting 44 participants aged between 40 and 80 who have been diagnosed with idiopathic Parkinson's disease. To be eligible, patients must also meet a set of criteria including: modified Hoehn & Yahr stages 1-3 per physical examination by an accredited therapist, able to walk independently for 10 minutes or more without aid from assistive devices or other people, consistent PD medication regimen for two weeks prior to enrollment, willing and capable of providing informed consent along with HIPAA Authorization granting communication rights between the patient and their primary care physician."
How many individuals are enrolling in this trial?
"Confirmed. Clinicaltrials.gov displays that this trial, which was activated on August 1st of 2022, is still recruiting patients to participate in the study. A total of 44 participants must be sourced from a single medical site."
What objectives is this medical research hoping to fulfill?
"This clinical trial seeks to evaluate gait quality by measuring stride length variability over a two-week follow-up period. Secondary outcomes include the Geriatric Depression Scale (GDS), Parkinson's disease Questionnaire - 39 (PDQ-39) and the 10 Meter Walk Test (10MWT). The GDS is composed of yes/no questions, with higher scores representing increased depression levels up to 15 points. The PDQ-39 measures patient quality of life using an ordinal 5 point system, while lower numbers indicate better wellbeing up to 100 points. Lastly, the 10MWT evaluates short distance walking function at both comfortable and maximum"
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