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Virtual Rehab Cycling for Parkinson's Disease (PDBIKE Trial)

N/A

Recruiting

Led By Aasef G. Shaikh, MD PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hoehn and Yahr (H&Y) stages I-III when off medication

Ability to perform informed consent

Must not have

Clinical diagnosis including perinatal brain injury, stroke, and atypical parkinsonism

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before intervention, immediately after intervention (at week 4), 3 month, and 6 month after intervention.

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new, virtual way to give personalized rehab to people with Parkinson's disease, which could help many patients who can't travel to specialized facilities.

Who is the study for?

This trial is for individuals with Parkinson's Disease who can consent, have been on stable Parkinson's medication for at least six months, and are in stages I-III of the disease without medication. It excludes those with severe cognitive impairment, depression or anxiety disorders, certain other neurological conditions, untreated cardiovascular issues, or significant fatigue or breathlessness during mild activity.

What is being tested?

The study tests a new rehab method called dynamic cycling that patients can do from home using virtual technology. This could help people who can't travel to specialized centers due to various limitations like pandemics or lack of resources.

What are the potential side effects?

While specific side effects aren't listed for this type of physical therapy intervention, typical concerns may include muscle soreness or fatigue related to exercise. The remote nature also requires participants to be comfortable with virtual interfaces.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My Parkinson's is in the early to mid stages without medication.

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I understand and can give consent for my treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a brain injury, stroke, or a type of Parkinson's disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before intervention, immediately after intervention (at week 4), 3 month, and 6 month after intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before intervention, immediately after intervention (at week 4), 3 month, and 6 month after intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and before intervention, immediately after intervention (at week 4), 3 month, and 6 month after intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Intensity of abnormal movements measured with wearable sensors (acceleorometers)

Secondary study objectives

Activity-specific Balance Confidence scale

Berg Balance test

Mini Balance Evaluation System Test

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Dynamic cyclingExperimental Treatment1 Intervention

The cycling parameters will change according to motor performance of the participants. Motor performance will be measured by assessing the change in tremor and movement speed.

Group II: Forced cyclingActive Control1 Intervention

The cycling parameters will not change regardless of the motor performance. Motor performance will be measured by assessing the change in tremor and movement speed.

0 / 3Eligibility criteria met