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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
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
PDBIKE Trial 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.Check my eligibility
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.See study design
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.
PDBIKE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My Parkinson's is in the early to mid stages without medication.
Select...
I understand and can give consent for my treatment.
PDBIKE Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Intensity of abnormal movements measured with wearable sensors (acceleorometers)
Secondary outcome measures
Activity-specific Balance Confidence scale
Berg Balance test
Mini Balance Evaluation System Test
+1 morePDBIKE 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.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,614 Previous Clinical Trials
3,305,781 Total Patients Enrolled
Aasef G. Shaikh, MD PhDPrincipal InvestigatorLouis Stokes VA Medical Center, Cleveland, OH
1 Previous Clinical Trials
40 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have symptoms like chest pain or shortness of breath, indicating heart issues.My Parkinson's is in the early to mid stages without medication.My Parkinson's medication has been the same for at least 6 months.I have been diagnosed with a brain injury, stroke, or a type of Parkinson's disease.Your anxiety score is higher than 24 on the Hamilton scale.You have been diagnosed with Parkinson's disease using the UK Brain Bank criteria.You scored less than 18 on a test that measures memory and thinking skills.I understand and can give consent for my treatment.You have a score of 20 or higher on a test that measures how sad or down you feel.
Research Study Groups:
This trial has the following groups:- Group 1: Dynamic cycling
- Group 2: Forced cycling
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are currently enrolled in this trial?
"Affirmative. Clinicaltrials.gov attests that this medical trial, which was initially made available on April 1st 2022 is currently seeking participants. 72 individuals are desired from a single research site."
Answered by AI
Are enrollment slots still available for this research project?
"Affirmative, the trial is currently recruiting participants. According to clinicaltrials.gov, it was first posted on April 1st 2022 and last edited a few weeks later on April 12th 2022. A total of 72 patients will be admitted at a single site."
Answered by AI
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