Parkinson Disease
Conditions
Keywords
feasibility device testing
Brief 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.
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.
Interventions
DEVICEMultifunctional RehabilitationDevice (MRD)
Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP
DEVICEexisting standard rehabilitation device
existing standard rehabilitation device to be used for in-home comparison testing for aim 3
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| (Aim 1) Mean of User Acceptance Questionnaire (UAQ) Part 1 Total Scores | After 1-hour session using the device | 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. |
| (Aim 1) Mean of User Acceptance Questionnaire (UAQ) Part 2 Total Scores | After 1-hour session using the device | 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. |
| (Aim 1) Mean System Usability Scale (SUS) Total Scores | After 1-hour session using the device | 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. |
| (Aim 2) Change in Mean Time to Complete the Instrumented Timed Up and Go Test (iTUG) | After 2-week intervention | 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. |
| (Aim 2) Change in Mean Duration of Balance During Romberg Test Condition | After 2-week intervention | 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. |
| (Aim 2) Change in Mean Response Time During the Stroop Stepping Test | After 2-week intervention | 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. |
| (Aim 2) Change in Mean of Time Taken to Complete Stroop Color Word Interference Test | After 2-week intervention | 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). |
| (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. | After 14-week intervention | 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. |
| (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. | After 14-week intervention | 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. |
| (Aim 3) Difference in Effect of Intervention on Sensory Postural Control Domain as Measured During the MiniBESTest. | After 14-week intervention | 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. |
| (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. | After 14-week intervention | 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. |
| (Aim 3) Mean Modified Hoehn and Yahr Stage at Baseline | At baseline (descriptive statistic) | 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). |
| (Aim 3) Difference in Effect of Intervention on Response Time During the Stroop Stepping Test in Study Device Group Versus Control Groups. | After 14-week intervention | 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. |
| (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. | After 14-week intervention | 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). |
Countries
United States
Participant flow
Recruitment details
This study was originally intended to be completed as a sequence from Aim 1 to Aim 2, then to Aim 3. However, due to scheduling conflicts and attrition, subjects were invited to participate in individual aims to ensure sufficient data collection for each aim. Since some subjects completed multiple aims while others completed all aims, results were analyzed by aim, and thus are presented in that way here. In total, 38 participants were enrolled, with 1 withdrawal prior to randomization.
Pre-assignment details
Of the 37 unique participants who started study procedures, 29 participated in only one aim of the study, while 8 participated in multiple. Of the 8 participants who participated in multiple aims, 2 participants started procedures for aims 1 and 2 only, 3 participants started aims 1 and 3 only, 1 participant started aims 2 and 3 only, and 2 participants started all 3 aims.
Participants by arm
| Arm | Count |
|---|---|
| Participants Whose 1st Participation Was in Aim 1 Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions. | 18 |
| Participants Whose First Participation Was in Aim 2 Multifunctional rehabilitation device for PwP for human user acceptance testing for 5 lab sessions. | 8 |
| Participants Whose 1st Participation Was in Aim 3: In-Home Testing - Research Device Arm Participants of the in-home feasibility trial who were randomized into the research device group. This group includes some participants who also participated in Aims 1 or 2 but dual enrollment did not play a role in analysis of this arm. | 7 |
| Participants Whose 1st Participation Was in Aim 3: In-Home Testing - Alternate Device Arm Participants of the in-home feasibility trial who were randomized into the alternate device group. This group includes some participants who also participated in Aims 1 or 2 but dual enrollment did not play a role in analysis of this arm. | 7 |
| Participants Whose 1st Participation Was in Aim 3: In-Home Testing - No Device Arm Participants of the in-home feasibility trial who were randomized into the no device group. This group includes some participants who also participated in Aims 1 or 2 but dual enrollment did not play a role in analysis of this arm. | 7 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Completed Aim 3 - Alternate Device Arm | Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 |
| Completed Aim 3 - No Device Arm | Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 |
| Completed Aim 3 - Research Device Arm | Withdrawal by Subject | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Participants Whose 1st Participation Was in Aim 1 | Participants Whose First Participation Was in Aim 2 | Participants Whose 1st Participation Was in Aim 3: In-Home Testing - No Device Arm | Participants Whose 1st Participation Was in Aim 3: In-Home Testing - Research Device Arm | Participants Whose 1st Participation Was in Aim 3: In-Home Testing - Alternate Device Arm |
|---|---|---|---|---|---|---|
| Age, Continuous Completed Data Collection for Aim 1 | 71.23 years STANDARD_DEVIATION 7.94 | 71.23 years STANDARD_DEVIATION 7.94 | — | — | — | — |
| Age, Continuous Completed Data Collection for Aim 2 | 69.38 years STANDARD_DEVIATION 9.07 | 68 years STANDARD_DEVIATION 11.8 | 70.75 years STANDARD_DEVIATION 6.9 | — | — | — |
| Age, Continuous Completed Data Collection for Aim 3 | 68.29 years STANDARD_DEVIATION 5.09 | 71.8 years STANDARD_DEVIATION 3.27 | 68 years STANDARD_DEVIATION 0 | 67.6 years STANDARD_DEVIATION 5.9 | 65.2 years STANDARD_DEVIATION 4.87 | 68.6 years STANDARD_DEVIATION 5.68 |
| (Aim 3) Mean Modified Hoehn and Yahr stage | 2.09 units on a scale STANDARD_DEVIATION 0.53 | — | — | 2.17 units on a scale STANDARD_DEVIATION 0.61 | 2.17 units on a scale STANDARD_DEVIATION 0.41 | 1.92 units on a scale STANDARD_DEVIATION 0.53 |
| (Aim 3) Mean Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III Score | 34.28 units on a scale STANDARD_DEVIATION 12.41 | — | — | 32.25 units on a scale STANDARD_DEVIATION 10.55 | 37.58 units on a scale STANDARD_DEVIATION 14.61 | 33 units on a scale STANDARD_DEVIATION 12.06 |
| (Aim 3) Mean response time during the Stroop Stepping Test | 2.00 seconds STANDARD_DEVIATION 0.3 | — | — | 1.99 seconds STANDARD_DEVIATION 0.15 | 2.10 seconds STANDARD_DEVIATION 0.42 | 1.92 seconds STANDARD_DEVIATION 0.34 |
| (Aim 3) Mean time taken to complete Stroop Color Word Interference Test | 166.28 seconds STANDARD_DEVIATION 56.93 | — | — | 167.76 seconds STANDARD_DEVIATION 30.6 | 162.25 seconds STANDARD_DEVIATION 62.74 | 168.82 seconds STANDARD_DEVIATION 77.46 |
| (Aim 3) Mean time to complete the Instrumented Stand up and Walk Test (iSAW) | 13.03 seconds STANDARD_DEVIATION 1.75 | — | — | 13.32 seconds STANDARD_DEVIATION 2.02 | 13.05 seconds STANDARD_DEVIATION 1.42 | 12.75 seconds STANDARD_DEVIATION 1.81 |
| (Aim 3) Mean time to complete the Timed Up and Go test (TUG) | 7.89 seconds STANDARD_DEVIATION 1.58 | — | — | 8.53 seconds STANDARD_DEVIATION 1.94 | 7.65 seconds STANDARD_DEVIATION 1.68 | 7.49 seconds STANDARD_DEVIATION 1.12 |
| (Aim 3) Sensory postural control domain as measured during the MiniBESTest. | 4.83 units on a scale STANDARD_DEVIATION 1.11 | — | — | 4.33 units on a scale STANDARD_DEVIATION 1.97 | 5.00 units on a scale STANDARD_DEVIATION 1 | 5.17 units on a scale STANDARD_DEVIATION 0.37 |
| Ethnicity (NIH/OMB) Completed Data Collection for Aim 1 Hispanic or Latino | 0 Participants | 0 Participants | — | — | — | — |
| Ethnicity (NIH/OMB) Completed Data Collection for Aim 1 Not Hispanic or Latino | 18 Participants | 18 Participants | — | — | — | — |
| Ethnicity (NIH/OMB) Completed Data Collection for Aim 1 Unknown or Not Reported | 0 Participants | 0 Participants | — | — | — | — |
| Ethnicity (NIH/OMB) Completed Data Collection for Aim 2 Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | — | — | — |
| Ethnicity (NIH/OMB) Completed Data Collection for Aim 2 Not Hispanic or Latino | 8 Participants | 4 Participants | 4 Participants | — | — | — |
| Ethnicity (NIH/OMB) Completed Data Collection for Aim 2 Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | — | — | — |
| Ethnicity (NIH/OMB) Completed Data Collection for Aim 3 Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Completed Data Collection for Aim 3 Not Hispanic or Latino | 21 Participants | 5 Participants | 1 Participants | 5 Participants | 5 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Completed Data Collection for Aim 3 Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Completed Data Collection for Aim 1 American Indian or Alaska Native | 0 Participants | 0 Participants | — | — | — | — |
| Race (NIH/OMB) Completed Data Collection for Aim 1 Asian | 0 Participants | 0 Participants | — | — | — | — |
| Race (NIH/OMB) Completed Data Collection for Aim 1 Black or African American | 0 Participants | 0 Participants | — | — | — | — |
| Race (NIH/OMB) Completed Data Collection for Aim 1 More than one race | 0 Participants | 0 Participants | — | — | — | — |
| Race (NIH/OMB) Completed Data Collection for Aim 1 Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | — | — | — | — |
| Race (NIH/OMB) Completed Data Collection for Aim 1 Unknown or Not Reported | 0 Participants | 0 Participants | — | — | — | — |
| Race (NIH/OMB) Completed Data Collection for Aim 1 White | 18 Participants | 18 Participants | — | — | — | — |
| Race (NIH/OMB) Completed Data Collection for Aim 2 American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | — | — | — |
| Race (NIH/OMB) Completed Data Collection for Aim 2 Asian | 0 Participants | 0 Participants | 0 Participants | — | — | — |
| Race (NIH/OMB) Completed Data Collection for Aim 2 Black or African American | 0 Participants | 0 Participants | 0 Participants | — | — | — |
| Race (NIH/OMB) Completed Data Collection for Aim 2 More than one race | 0 Participants | 0 Participants | 0 Participants | — | — | — |
| Race (NIH/OMB) Completed Data Collection for Aim 2 Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | — | — | — |
| Race (NIH/OMB) Completed Data Collection for Aim 2 Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | — | — | — |
| Race (NIH/OMB) Completed Data Collection for Aim 2 White | 8 Participants | 4 Participants | 4 Participants | — | — | — |
| Race (NIH/OMB) Completed Data Collection for Aim 3 American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Completed Data Collection for Aim 3 Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Completed Data Collection for Aim 3 Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Completed Data Collection for Aim 3 More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Completed Data Collection for Aim 3 Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Completed Data Collection for Aim 3 Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Completed Data Collection for Aim 3 White | 21 Participants | 5 Participants | 1 Participants | 5 Participants | 5 Participants | 5 Participants |
| Region of Enrollment United States | 37 Participants | 18 Participants | 4 Participants | 5 Participants | 5 Participants | 5 Participants |
| Sex: Female, Male Completed Data Collection for Aim 1 Female | 4 Participants | 4 Participants | — | — | — | — |
| Sex: Female, Male Completed Data Collection for Aim 1 Male | 14 Participants | 14 Participants | — | — | — | — |
| Sex: Female, Male Completed Data Collection for Aim 2 Female | 2 Participants | 0 Participants | 2 Participants | — | — | — |
| Sex: Female, Male Completed Data Collection for Aim 2 Male | 6 Participants | 4 Participants | 2 Participants | — | — | — |
| Sex: Female, Male Completed Data Collection for Aim 3 Female | 9 Participants | 2 Participants | 1 Participants | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Completed Data Collection for Aim 3 Male | 12 Participants | 3 Participants | 0 Participants | 3 Participants | 4 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 8 | 0 / 7 | 0 / 7 | 0 / 7 |
| other Total, other adverse events | 1 / 18 | 0 / 8 | 7 / 7 | 6 / 7 | 4 / 7 |
| serious Total, serious adverse events | 0 / 18 | 0 / 8 | 0 / 7 | 0 / 7 | 1 / 7 |
Outcome results
Primary
(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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) | (Aim 1) Mean of User Acceptance Questionnaire (UAQ) Part 1 Total Scores | 7.28 score on a scale | Standard Deviation 6.18 |
Primary
(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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) | (Aim 1) Mean of User Acceptance Questionnaire (UAQ) Part 2 Total Scores | 23.72 score on a scale | Standard Deviation 5.12 |
Primary
(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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) | (Aim 1) Mean System Usability Scale (SUS) Total Scores | 83.19 score on a scale | Standard Deviation 14.09 |
Primary
(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
Population: Although in participant flow, the 8 participants are divided by what arm they subsequently participated in, within this outcome measure, there is no logical reason to separate them, as they were all testing the same device used in the same manner.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) | (Aim 2) Change in Mean Duration of Balance During Romberg Test Condition | Pre-Intervention | 26.25 seconds | Standard Deviation 10.61 |
| In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) | (Aim 2) Change in Mean Duration of Balance During Romberg Test Condition | Post-Intervention | 30 seconds | Standard Deviation 0 |
p-value: 0.351t-test, 2 sided
Primary
(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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) | (Aim 2) Change in Mean of Time Taken to Complete Stroop Color Word Interference Test | Pre-Intervention | 167.51 seconds | Standard Deviation 55.96 |
| In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) | (Aim 2) Change in Mean of Time Taken to Complete Stroop Color Word Interference Test | Post-Intervention | 152.71 seconds | Standard Deviation 54.54 |
p-value: 0.044t-test, 2 sided
Primary
(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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) | (Aim 2) Change in Mean Response Time During the Stroop Stepping Test | Pre-Intervention | 1.887 seconds | Standard Deviation 0.27 |
| In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) | (Aim 2) Change in Mean Response Time During the Stroop Stepping Test | Post-Intervention | 1.874 seconds | Standard Deviation 0.42 |
p-value: 0.937t-test, 2 sided
Primary
(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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) | (Aim 2) Change in Mean Time to Complete the Instrumented Timed Up and Go Test (iTUG) | Pre-Intervention | 18.761 seconds | Standard Deviation 5.651 |
| In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) | (Aim 2) Change in Mean Time to Complete the Instrumented Timed Up and Go Test (iTUG) | Post-Intervention | 18.124 seconds | Standard Deviation 4.7 |
p-value: 0.429t-test, 2 sided
Primary
(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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) | (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. | Pre-Intervention | 37.58 score on a scale | Standard Deviation 14.61 |
| In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) | (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. | Post-Intervention | 36.83 score on a scale | Standard Deviation 12.91 |
| In-home Feasibility Testing (Alternate Device) | (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. | Pre-Intervention | 33 score on a scale | Standard Deviation 12.06 |
| In-home Feasibility Testing (Alternate Device) | (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. | Post-Intervention | 27.67 score on a scale | Standard Deviation 8.86 |
| In-home Feasibility Testing (no Device in at Home Portion) | (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. | Pre-Intervention | 32.25 score on a scale | Standard Deviation 10.55 |
| In-home Feasibility Testing (no Device in at Home Portion) | (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. | Post-Intervention | 36.58 score on a scale | Standard Deviation 9.55 |
p-value: 0.058ANCOVA
p-value: 0.718ANCOVA
Primary
(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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) | (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. | Pre-Intervention | 13.05 seconds | Standard Deviation 1.42 |
| In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) | (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. | Post-Intervention | 12.40 seconds | Standard Deviation 1.76 |
| In-home Feasibility Testing (Alternate Device) | (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. | Pre-Intervention | 12.72 seconds | Standard Deviation 1.81 |
| In-home Feasibility Testing (Alternate Device) | (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. | Post-Intervention | 11.35 seconds | Standard Deviation 1.99 |
| In-home Feasibility Testing (no Device in at Home Portion) | (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. | Pre-Intervention | 13.32 seconds | Standard Deviation 2.02 |
| In-home Feasibility Testing (no Device in at Home Portion) | (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. | Post-Intervention | 11.92 seconds | Standard Deviation 2.21 |
p-value: 0.986ANCOVA
p-value: 0.479ANCOVA
Primary
(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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) | (Aim 3) Difference in Effect of Intervention on Response Time During the Stroop Stepping Test in Study Device Group Versus Control Groups. | Pre-Intervention | 2.10 seconds | Standard Deviation 0.42 |
| In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) | (Aim 3) Difference in Effect of Intervention on Response Time During the Stroop Stepping Test in Study Device Group Versus Control Groups. | Post-Intervention | 1.92 seconds | Standard Deviation 0.5 |
| In-home Feasibility Testing (Alternate Device) | (Aim 3) Difference in Effect of Intervention on Response Time During the Stroop Stepping Test in Study Device Group Versus Control Groups. | Pre-Intervention | 1.92 seconds | Standard Deviation 0.34 |
| In-home Feasibility Testing (Alternate Device) | (Aim 3) Difference in Effect of Intervention on Response Time During the Stroop Stepping Test in Study Device Group Versus Control Groups. | Post-Intervention | 1.83 seconds | Standard Deviation 0.33 |
| In-home Feasibility Testing (no Device in at Home Portion) | (Aim 3) Difference in Effect of Intervention on Response Time During the Stroop Stepping Test in Study Device Group Versus Control Groups. | Pre-Intervention | 1.99 seconds | Standard Deviation 0.15 |
| In-home Feasibility Testing (no Device in at Home Portion) | (Aim 3) Difference in Effect of Intervention on Response Time During the Stroop Stepping Test in Study Device Group Versus Control Groups. | Post-Intervention | 1.97 seconds | Standard Deviation 0.33 |
p-value: 0.816ANCOVA
p-value: 0.985ANCOVA
Primary
(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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) | (Aim 3) Difference in Effect of Intervention on Sensory Postural Control Domain as Measured During the MiniBESTest. | Pre-Intervention | 5.00 units on a scale | Standard Deviation 1 |
| In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) | (Aim 3) Difference in Effect of Intervention on Sensory Postural Control Domain as Measured During the MiniBESTest. | Post-Intervention | 3.83 units on a scale | Standard Deviation 1.46 |
| In-home Feasibility Testing (Alternate Device) | (Aim 3) Difference in Effect of Intervention on Sensory Postural Control Domain as Measured During the MiniBESTest. | Pre-Intervention | 5.17 units on a scale | Standard Deviation 0.37 |
| In-home Feasibility Testing (Alternate Device) | (Aim 3) Difference in Effect of Intervention on Sensory Postural Control Domain as Measured During the MiniBESTest. | Post-Intervention | 4.5 units on a scale | Standard Deviation 1.71 |
| In-home Feasibility Testing (no Device in at Home Portion) | (Aim 3) Difference in Effect of Intervention on Sensory Postural Control Domain as Measured During the MiniBESTest. | Pre-Intervention | 4.33 units on a scale | Standard Deviation 1.97 |
| In-home Feasibility Testing (no Device in at Home Portion) | (Aim 3) Difference in Effect of Intervention on Sensory Postural Control Domain as Measured During the MiniBESTest. | Post-Intervention | 3.33 units on a scale | Standard Deviation 1.6 |
p-value: 0.098ANCOVA
p-value: 0.729ANCOVA
Primary
(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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) | (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. | Pre-Intervention | 162.25 seconds | Standard Deviation 62.74 |
| In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) | (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. | Post-Intervention | 158.53 seconds | Standard Deviation 63.42 |
| In-home Feasibility Testing (Alternate Device) | (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. | Pre-Intervention | 168.82 seconds | Standard Deviation 77.46 |
| In-home Feasibility Testing (Alternate Device) | (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. | Post-Intervention | 163.19 seconds | Standard Deviation 72.97 |
| In-home Feasibility Testing (no Device in at Home Portion) | (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. | Pre-Intervention | 167.76 seconds | Standard Deviation 30.6 |
| In-home Feasibility Testing (no Device in at Home Portion) | (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. | Post-Intervention | 153.95 seconds | Standard Deviation 20.57 |
p-value: 0.59ANCOVA
p-value: 0.51ANCOVA
Primary
(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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) | (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. | Pre-Intervention | 7.65 seconds | Standard Deviation 1.68 |
| In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) | (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. | Post-Intervention | 8.27 seconds | Standard Deviation 1.77 |
| In-home Feasibility Testing (Alternate Device) | (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. | Pre-Intervention | 7.49 seconds | Standard Deviation 1.12 |
| In-home Feasibility Testing (Alternate Device) | (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. | Post-Intervention | 6.83 seconds | Standard Deviation 1.42 |
| In-home Feasibility Testing (no Device in at Home Portion) | (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. | Pre-Intervention | 8.53 seconds | Standard Deviation 1.94 |
| In-home Feasibility Testing (no Device in at Home Portion) | (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. | Post-Intervention | 8.47 seconds | Standard Deviation 2.34 |
p-value: 0.42ANCOVA
p-value: 0.5ANCOVA
Primary
(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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) | (Aim 3) Mean Modified Hoehn and Yahr Stage at Baseline | 2.17 score on a scale | Standard Deviation 0.41 |
| In-home Feasibility Testing (Alternate Device) | (Aim 3) Mean Modified Hoehn and Yahr Stage at Baseline | 1.92 score on a scale | Standard Deviation 0.58 |
| In-home Feasibility Testing (no Device in at Home Portion) | (Aim 3) Mean Modified Hoehn and Yahr Stage at Baseline | 2.17 score on a scale | Standard Deviation 0.61 |