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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP
existing standard rehabilitation device to be used for in-home comparison testing for aim 3
The University of Michigan
Ann Arbor, Michigan, United States
(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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: After 14-week intervention
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