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Behavioural Intervention
Multifunctional Rehabilitation Device for Parkinson's Disease
N/A
Waitlist Available
Led By James Richardson, MD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-2 years
Awards & highlights
Study Summary
This trial will test a device to help people with Parkinson's improve their motor & cognitive functions. Possible benefits will be tested in a future study.
Who is the study for?
This trial is for people with Parkinson's Disease who can follow the study rules. It's not for those with other serious health issues, psychiatric conditions, or a big drop in blood pressure when standing. The researchers will also exclude anyone they think might be at risk or unable to handle the research tasks.Check my eligibility
What is being tested?
The study is testing a new Multifunctional Rehabilitation Device (MRD) against standard rehab devices through three parts: tests in a lab setting both once and multiple times, and use at home. Participants may keep the device after the trial to provide feedback on its long-term use.See study design
What are the potential side effects?
While specific side effects are not listed, participants could experience discomfort using the MRD based on their feedback during an optional open label extension where they can report their user experience.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean of Kinematic Variables from APDM Joint Sensors
Mean of Number of Incorrect Responses on the Stroop Color Word Stepping Test
Mean of Time Taken to Complete Task and Number of Incorrect Responses on the Stroop Color Word Interference Test
+3 moreSecondary outcome measures
Mean of Blood Pressure
Bone and Bones
Mean of Force Measures from Handheld Dynamometer
+20 moreOther outcome measures
Mean VO2 Energy Expenditure
Mean of Blood Glucose Levels from Continuous Glucose Monitor
Actigraphy
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: In-lab and in home feasibility testing of research device in people with Parkinson's disease (PwP)Experimental Treatment1 Intervention
Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions (aim 1) and 5 lab sessions (aim 2). This arm will use the experimental device in home feasibility testing (aim 3). This arm will be asked to participate in the open label extension.
Group II: In-home feasibility testing (no device in at home portion)Experimental Treatment1 Intervention
Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions (aim 1) and 5 lab sessions (aim 2). For the at home portion, this arm will not use any device but have the same outcomes measured. (aim 3)
Group III: In-home feasibility testing (alternate device)Active Control2 Interventions
Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions (aim 1) and 5 lab sessions (aim 2).
This arm will use another device to compare to the experimental device for in home feasibility of using the device at home (aim 3). This arm will be asked to participate in the open label extension.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Multifunctional RehabilitationDevice (MRD)
2022
N/A
~40
Find a Location
Who is running the clinical trial?
University of MichiganLead Sponsor
1,795 Previous Clinical Trials
6,373,898 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,339 Previous Clinical Trials
649,268 Total Patients Enrolled
James Richardson, MDPrincipal InvestigatorUniversity of Michigan
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- If you feel dizzy or lightheaded when you stand up, you might not be able to join the study.You have Parkinson's disease.
Research Study Groups:
This trial has the following groups:- Group 1: In-home feasibility testing (no device in at home portion)
- Group 2: In-lab and in home feasibility testing of research device in people with Parkinson's disease (PwP)
- Group 3: In-home feasibility testing (alternate device)
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.
Are there any spots available for enrollment in this experiment?
"Affirmative - According to clinicaltrials.gov, this medical study which was initially posted on October 13th 2022 is actively enrolling participants. The trial needs 18 patients from a single site to reach completion."
Answered by AI
What goals is this trial attempting to accomplish?
"This 14 week long trial seeks to quantify the Mean of Kinematic Variable from APDM Joint Sensors, whilst also assessing the Proportion of Participants with Decrease in Pain on the Modified Numeric Stance Discomfort Rating Scale (whereby ratings 0-10 denote no discomfort through to severe pain), evaluating alertness using Epworth Sleepiness Scale scores and determining performance during a Computerized Reaction Stick Test which gauges reaction time differences pre/post intervention."
Answered by AI
How many participants has this research enrolled thus far?
"Affirmative. Clinicaltrials.gov displays that, as of October 13th 2022, this clinical trial is actively soliciting volunteers with the aim of recruiting 18 subjects from one medical facility."
Answered by AI
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