Development of a Multifunctional Rehabilitation Device for Persons With Parkinson's Disease

Study Overview
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Brief Summary
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The researchers have developed a multifunctional rehabilitation device that will be tested in this feasibility trial across three sub-studies: (i) dual session in-lab; (ii) multi-session in-lab and (iii) in the participant's home. A long-term outcome is to test possible benefits of this device (if accepted by the user Parkinson population) on motor and cognitive functions in a clinical trial in a future study. Participants who receive a device during the in-home trial will have the option to keep the device for up to two years in an open label extension. During this extension, participants can optionally provide feedback on their user experience such as discomfort.

Detailed Description
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The primary purpose of this feasibility study is to assess human user acceptance of the device during 2 lab sessions (aim 1) from which the persons will proceed to 5 lab sessions (aim 2) and during in-home use (aim 3). The in-home aim will also include control persons to allow exploratory collection of clinical data that may provide preliminary outcome data to properly power a future phase 2 randomized clinical trial. The open label extension will provide information on the efficacy of using the device long-term. While 18 persons may appear to be a larger than normal number for a device feasibility trial, because Parkinsons patients have a wide range of clinical symptoms, in order to acquire any meaningful data, some spread must be achieved. For example, 3 individuals in several different symptomatic categories. Further, there is some chance of attrition. Lastly, to be clear, details of device design may continue to be modified throughout the study.

Official Title
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Development of a Multifunctional Rehabilitation Standing and Stepping Device for Persons With Parkinson's Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: Multifunctional RehabilitationDevice (MRD)
* Device: existing standard rehabilitation device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parkinson's disease Willing and able to comply with study requirements Exclusion Criteria: Subjects with other neurological, psychiatric, unstable medical conditions, or that experience a drop in blood pressure upon standing (orthostasis) may be excluded Subjects who, in the opinion of the investigators, would be at increased risk or who are unable to perform or tolerate the research procedures will be excluded.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The feasibility study will involve a sequential stage of device feasibility testing with the initial aims 1 and 2 being a single group and the in-home feasibility testing will involve controls persons for an exploratory data collection. The same participants are asked to proceed sequentially through the three phase of the study. Participants in the third sub-study will then be asked to complete the open label extension.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: In-lab and in home feasibility testing of research device in people with Parkinson's disease (PwP)<br>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. | Device: Multifunctional RehabilitationDevice (MRD)<br>* Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP<br>* Other names: MRD;|
| Active Comparator: In-home feasibility testing (alternate device)<br>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. | Device: Multifunctional RehabilitationDevice (MRD)<br>* Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP<br>* Other names: MRD;Device: existing standard rehabilitation device<br>* existing standard rehabilitation device to be used for in-home comparison testing for aim 3<br>|
| Other: In-home feasibility testing (no device in at home portion)<br>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) | Device: Multifunctional RehabilitationDevice (MRD)<br>* Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP<br>* Other names: MRD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Number of Related Adverse Events Throughout Study Duration | This will indicate the number of possible adverse events during device use which will help determine the safety of the intervention. | 1-2 years | 
| Mean of Time Taken to Complete the Timed Up and Go Test | Participants are timed while performing the task and this can be averaged from pre and post intervention visits. This will be used to compare the time it takes for participants to get up from a chair, walk, turning around, and sitting again before and after the intervention to determine if motor function improves (indicated by decreased time). | 1-14 week(s) | 
| Mean of Time Taken to Complete Tasks (ISAW and ISWAY) on the MiniBest Test | During this test, participants read congruent and incongruent colored names of colors. This will be used to compare the number of incorrect responses and the time it takes to complete the test from pre and post intervention visits to determine if inhibitory control improves (indicated by decrease of incorrect responses and completion time). | 1-14 weeks | 
| Mean of Number of Incorrect Responses on the Stroop Color Word Stepping Test | During this test, subjects make steps based on congruent (stimulus prompts the stepping response) and incongruent (stimulus prompts inhibition of the stepping response) arrows and sounds. This will be used to compare the number of incorrect responses (stepping) from pre and post intervention visits to determine if inhibitory control improves (indicated by decrease in number of incorrect responses). | 1-14 weeks | 
| Mean of Time Taken to Complete Task and Number of Incorrect Responses on the Stroop Color Word Interference Test | During this test, participants read congruent and incongruent colored names of colors. This will be used to compare the number of incorrect responses and the time it takes to complete the test from pre and post intervention visits to determine if inhibitory control improves (indicated by decrease of incorrect responses and completion time). | 1-14 weeks | 
| Mean of Kinematic Variables from APDM Joint Sensors | Opal APDM mobility lab sensors will be placed at limbs and trunk of body to track movements of joints. Data regarding gait speed and variability can be compared before and after the intervention to determine the effects of the device. | 1-14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean of Force Measures from Handheld Dynamometer | Participants will perform different abduction exercises with the microFET3 handheld dynamometer which will output the strength and range of motion values. This will allow for comparison between the force and flexibility of hip abductors from pre and post intervention visits to determine if muscle strength (force in Newtons) and range of motion (in degrees) increases. | 1-14 weeks | 
| Mean of Number of Correct Responses on the WAIS-III Digit Symbol Coding Test | Participants will use a key consisting of number and symbols to complete a pattern in a given amount of time. This will be used to compare the number of correct written symbols in a given amount of time from pre and post intervention visits to quantify if information processing speed improves (indicated by increased number of correct, written symbols). | 1-14 weeks | 
| Mean of Time Taken to Complete Tasks on the Delis-Kaplan Trail Making Test | Participants complete five conditions where they must draw a trail from different numbers and letters based on the instructions. Each condition is timed. We will compare the time it takes to complete different trail making conditions from pre and post intervention visits to determine the effect of the device on processing speed and visual attention (indicated by decreased completion time). | 1-14 weeks | 
| Mean of Number of Correct Responses on the Eriksen Flanker Test | Participants will be presented with different visual stimuli which disappear quickly and then must indicate where a specific stimulus was located on the computer screen. The computer measures if participant identified the correct stimulus quickly enough. Comparing the number of correct responses from pre and post intervention visits will be used to determine if concept shifting and visual attention improves after the intervention (indicated by increased number of correct responses). | 1-14 weeks | 
| Mean of Time Taken to Complete Task and Number of Correct Responses with the Computerized Reaction Stick Test | In the simple condition, participants will attempt to catch a stick after it is dropped and the reaction stick measures the time it takes for them to make contact. In the complex condition, participants will grab the stick when it lights up or let the stick drop if it does not light up. For the simple reaction condition, we will compare the average time it takes to catch a reaction stick from pre and post intervention visits to quantify reaction time (decreased grab time indicates improved performance). Additionally, in the complex reaction condition, we will compare the number of correct responses from pre and post intervention visits to determine if inhibitory control improves (indicated by increased number of correct responses). | 1-14 weeks | 
| Mean of Blood Pressure | Blood pressure (mm Hg) will be taken during pre and post intervention visits to track the effects of the device. | 1-14 weeks | 
| Mean of Heart rate | Heart rate measures (beats per minute) will be taken during pre and post intervention visits to track the effects of the device. | 1-14 weeks | 
| Mean of Bone Density Rating Score from a Whole-Body DEXA Scan | Participants will be given a bone density scan which can be compared before and after the intervention to see if the device has any effect (indicated by improved bone density rating). | 1-14 weeks | 
| Proportion of Participants with Decrease in Fatigue on the Fatigue Severity Scale | This questionnaire asks about motivation and fatigue and participants must rate from 1-7 how strongly they agree with the statement where 1 is disagree and 7 is agree. Comparisons between participant ratings of fatigue before and after the intervention can be used to determine if consistently using the device decreases perceived fatigue (indicated by a decreased score). | 1-14 weeks | 
| Proportion of Participants with Increase in Confidence on the Activities-Specific Balance Confidence Scale (shortened version) | The scale is 6 questions that asks participants to provide their percent confidence in not losing their balance during activities such as walking up the stairs. This will be used to quantify how confident participants are about not losing their balance during various tasks before and after the intervention to determine if the device improves confidence of balance (indicated by increased scores). | 1-14 weeks | 
| Proportion of Participants with Increased Sleep Quality on the Mayo Sleep Questionnaire | This questionnaire consists of 8 different questions that ask about acting out dreams and injuries that result from this. More NO responses indicate less severe incidents and injuries. This will measure how severe the participants act out their dreams before and after the intervention to determine if using the interventional device improves sleep (indicated by a greater number of NO responses). | 1-14 weeks | 
| Proportion of Participants with Decreased Insomnia on the Insomnia Severity Index | This questionnaire is 5 questions and asks participants about how satisfied they are with their sleep and how concerning their insomnia is. Higher ratings indicate a lower quality of sleep. This will quantify the level of insomnia participants experience before and after the intervention to determine if the device improves sleeping habits (indicated by a decreased score). | 1-14 weeks | 
| Proportion of Participants with Increased Daily Independence on Instruments of Daily Living | This questionnaire consists of 14 questions and participants can choose from various answers that describe different levels of capabilities. A greater ability to complete a task independently is a higher score. This can be used to compare participant ratings on how able they are to complete various tasks of daily living such as preparing food or housekeeping before and after the intervention to quantify if using the device improves abilities (indicated by an increased score). | 1-14 weeks | 
| Proportion of Participants that Indicate Device is Feasible on MRD-specific Human User Acceptance Study Questionnaire | This will be used to determine the proportion of participants who indicate the interventional device is usable, safe, and feasible for people with Parkinson's on the self-report questionnaire. This questionnaire consists of 9 questions that ask about ease of use, the possibility of using the interventional device at home, and preferred settings of the device. We are looking for 80% of participants to indicate the device is acceptable to use. | 1-14 week(s) | 
| Proportion of Participants with Decrease in Pain on the Modified Numeric Stance Discomfort Rating Scale | This scale asks for participants perceived pain in various body parts, participants will score pain on a 0-10 scale where 0 is no discomfort, 5 is moderate discomfort, and 10 is sever discomfort/pain. | 1-2 years | 
| Proportion of Participants that Indicate Device is Usable on System Usability Scale (SUS) | This scale consists of 10 questions on the usability of the MRD device and participants can give a 1-5 rating where 1 is strongly disagree and 5 is strongly agree. Again, we are looking for at least 80% of participants to indicate the MRD device is usable for people with Parkinson's. | 1-14 weeks | 
| Proportion of Participants with Increased Alertness on the Epworth Sleepiness Scale | This is an 8-question form and participants can give a rating 0-3 on the likelihood of dosing during activities such as riding in the car. A greater score indicates a greater chance of dosing. We will compare the results before and after the intervention to determine if the device influences perceived energy levels. | 1-14 weeks | 
| Proportion of Participants with Increased Confidence in Daily Life on the Short Falls Efficacy Scale (sFES) | This questionnaire consists of 7 questions and asks participants to rank how concerned they are about completing daily activities such as getting dressed or showering. This scale goes from 0 to 21 where a higher score means greater concerns about falling. These ratings will be compared before and after the intervention to determine if the device influences confidence of balance. | 1-14 weeks | 
| Proportion of Participants with Increased Quality of Life on the Parkinson's Disease Questionnaire (PDQ-39) | The PDQ-39 is a 39-question survey that asks participants to rate how frequently difficulties occur in their everyday life. A lower frequency indicates a greater quality of life for people with Parkinson's. The scale ranges from 0 to 100 where a lower score means a higher quality of life. We will compare scores before and after the intervention and determine the proportion of participants who see an improvement. | 1-14 weeks | 
| Proportion of Participants with Increased Physical Activity Levels on Activity Questionnaire | This is a subjective measure of activity which can be compared to the actigraphy data. This questionnaire asks about moderate and vigorous activity, as well as time spent sitting. We are interested in determining if physical activity levels increase throughout the interventional period. | 1-14 weeks | 
| Mean of Hand Grip Strength Measured by a Handheld Dynamometer | Measuring the grip strength of participants' hands (right and left side) via a handheld dynamometer at the pre and post-intervention visits to discover if the device improves grip strength (indicated by greater force reading on the handheld dynamometer). | 1-14 weeks | 
| Mean of Time Spent Holding a Lateral Plank | Measuring the time participants spend holding a lateral plank to quantify core strength. This will be measured at pre and post-intervention visits to determine if the device improves core strength (indicated by increased time spent holding a plank). The plank is completed on both the dominant and non-dominant side. | 1-14 weeks | 
| Mean of Lower Limb Explosive Power from the Vertical Jump Test (VJT) | Measuring lower limb explosive power using the vertical jump test (VJT) at pre and post intervention visits to determine if there is a benefit of the device (indicated by increased power which is calculated from body mass and jump reach). | 1-14 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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feasibility device testing