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

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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: Multifunctional RehabilitationDevice (MRD); Device: existing standard rehabilitation device

Detailed Description

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 45 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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • The University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Parkinson's disease
• Willing and able to comply with study requirements

Exclusion Criteria:

• Parkinson's disease dementia
• Parkinsonism plus syndromes
• Inability to stand, step, or walk without an assistive device
• History of symptoms in stance that preclude safe and comfortable participation, such as severe dizziness and lightheadedness, severe orthostasis, severe symptomatic leg or back musculoskeletal pain, painful neuropathy, significant ankle edema, or medication side effects
• History of symptomatic cardiovascular or pulmonary disease interfering with stance
• History of active rheumatic arthritis
• History of uncontrolled chronic pain syndrome
• Any other history of medical or psychiatric comorbidity precluding safe participation in the project
• Venous stasis or severe varicosities

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(Aim 1) Mean of User Acceptance Questionnaire (UAQ) Part 1 Total Scores	Completed at 2nd study visit after a 1-hour session using the device. UAQ part 1 assesses potential difficulties experienced while using the device. UAQ part 1 scores range from 0 to 90, with lower scores indicating fewer difficulties experienced.	After 1-hour session using the device
(Aim 1) Mean of User Acceptance Questionnaire (UAQ) Part 2 Total Scores	Completed at 2nd study visit after a 1-hour session using the device. UAQ part 2 assesses participant preferences for using the device. UAQ part 2 scores range from 0 to 30, with higher scores indicating greater personal preference for using the device.	After 1-hour session using the device
(Aim 1) Mean System Usability Scale (SUS) Total Scores	Completed at 2nd study visit after a 1-hour session using the device. SUS is a questionnaire consisting of 10 Likert-scale questions to assess usability of the device. Benchmarked scores range from 0 to 100, with higher scores indicating better usability of the device.	After 1-hour session using the device
(Aim 2) Change in Mean Time to Complete the Instrumented Timed Up and Go Test (iTUG)	Mobility test that evaluates the amount of time it takes the participants to stand, walk 10 feet, turn around, walk, and sit back down. Improved performance is indicated by lower time to complete measured in seconds.	After 2-week intervention
(Aim 2) Change in Mean Duration of Balance During Romberg Test Condition	Balance test that evaluates how long participants are able to stand on a foam pillow before losing balance. Improved performance is indicated by longer balance duration.	After 2-week intervention
(Aim 2) Change in Mean Response Time During the Stroop 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 mean response time for stepping from pre and post intervention visits to determine if reaction time improves (indicated by a decrease in response time). Mean times include responses to both congruent and incongruent stimuli.	After 2-week intervention
(Aim 2) Change in Mean of Time Taken to Complete 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).	After 2-week intervention
(Aim 3) Difference in Effect of Study Intervention on Mean Time to Complete the Instrumented Timed Up and Go Test (iTUG) in Study Device Group Versus Control Groups.	Mobility test that evaluates the amount of time it takes the participants to stand, walk 10 feet, turn around, walk, and sit back down. Improved performance is indicated by lower time to complete measured in seconds.	After 14-week intervention
(Aim 3) Difference in Effect of Intervention on Mean Time to Complete the Instrumented Stand and Walk Test (iSAW) in Study Device Group Versus Control Groups.	Mobility test that evaluates the amount of time it takes the participant to walk 10 feet, make a turn around a cone, and return to the starting position. Improved performance is indicated by lower time to complete measured in seconds.	After 14-week intervention
(Aim 3) Difference in Effect of Intervention on Sensory Postural Control Domain as Measured During the MiniBESTest.	Balance test that evaluates how long participants are able to stand on surfaces of varying firmness with eyes open and closed. Domain scores range from 0 to 6 with higher scores indicating stronger sensory postural control.	After 14-week intervention
(Aim 3) Difference in Effect of Intervention on Mean Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III Score in Study Device Group Versus Control Groups.	Movement Disorder Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS part III) is the motor examination portion of the UPDRS evaluation. Scores range from 0-132, with higher scores indicating greater severity of motor symptoms.	After 14-week intervention
(Aim 3) Mean Modified Hoehn and Yahr Stage at Baseline	The Hoehn and Yahr scale is a widely used clinical rating scale to categorize the progression of Parkinson's disease into stages ranging no disease (0) to wheelchair bound (5).	At baseline (descriptive statistic)
(Aim 3) Difference in Effect of Intervention on Response Time During the Stroop Stepping Test in Study Device Group Versus Control Groups.	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. These responses are combined to compare the response time for stepping from pre and post intervention visits to determine if reaction time improves (indicated by a decrease in response time). Mean times include responses to both congruent and incongruent stimuli.	After 14-week intervention
(Aim 3) Difference in Effect of Study Device Intervention on Time Taken to Complete Stroop Color Word Interference Test in Study Device Group Versus Control Groups.	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).	After 14-week intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 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
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 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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean of Different Physical Activity Measures from an Actigraphy Monitor (activPAL)	Participants will wear a monitor on their thigh for monitoring periods before and after the intervention. They will also keep a record of periods they remove the monitor. Measuring the activity level (i.e. step count, walking duration, etc.) throughout the intervention to determine if there are any carry-over effects of using the device on daily activity (indicated by an increase in daily activity).	1-14 weeks
Mean VO2 Energy Expenditure:	Participants will use the Cosmed metabolic tester which measures VO2 over time to determine the maximum level for that period. This will be compared from the pre and post intervention visits to quantify if the intervention leads to increased VO2 capacity.	1-14 weeks
Mean of Blood Glucose Levels from Continuous Glucose Monitor	Participants will wear a Dexcom CGM for monitoring periods before and after the invention. This automatically tracks changes in blood glucose levels. Tracking glucose levels for participants throughout the intervention will be used to determine if the device has any effect (indicated by a decrease in average blood glucose levels).	1-14 weeks
Mean of Time Spent Using the MRD Device	The time spent taking breaks during the use of the MRD device will be measured to determine total time utilization. Comparing the average time spent using the device will help to determine if the duration increases with repeated use.	1-2 years

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
• Investigators: Principal Investigator: Chatkaew Pongmala, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2022
• Primary Completion (Actual): December 14, 2023
• Study Completion (Actual): December 14, 2023

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: October 12, 2022
• First Posted (Actual): October 19, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 10, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: feasibility device testing
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: HUM00216022a; 1R41NS1129418 (Other Grant/Funding Number: NINDS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No