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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05586490
• Other study ID #: HUM00216022a
• Secondary ID: 1R41NS1129418
• Status: Completed
• Phase: N/A
• Start date: October 13, 2022
• Est. completion date: December 14, 2023

Study information

• Verified date: February 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 14, 2023
• Est. primary completion date: December 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Multifunctional RehabilitationDevice (MRD)
Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP
• existing standard rehabilitation device
existing standard rehabilitation device to be used for in-home comparison testing for aim 3

Locations

Country	Name	City	State
United States	The University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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