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| ID | Type | Description | Link |
|---|---|---|---|
| 1R41NS1129418 | Other Grant/Funding Number | NINDS |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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The researchers have developed a multifunctional rehabilitation device that will be tested in this feasibility trial across three sub-studies: (i) dual session in-lab; (ii) multi-session in-lab and (iii) in the participant's home. A long-term outcome is to test possible benefits of this device (if accepted by the user Parkinson population) on motor and cognitive functions in a clinical trial in a future study. Participants who receive a device during the in-home trial will have the option to keep the device for up to two years in an open label extension. During this extension, participants can optionally provide feedback on their user experience such as discomfort.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In-lab and in home feasibility testing of research device in people with Parkinson's disease (PwP) | Experimental | 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. |
|
| In-home feasibility testing (alternate device) | Active Comparator | 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. |
|
| In-home feasibility testing (no device in at home portion) | Other | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multifunctional RehabilitationDevice (MRD) | Device | Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chatkaew Pongmala, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants Whose 1st Participation Was in Aim 1 | Aim 1 consisted of 2-sessions of in-lab feasibility testing of research device in people with Parkinson disease(PwP) |
| FG001 | Participants Whose First Participation Was in Aim 2 | Aim 2 consists of 5-sessions of in-lab feasibility testing of research device in people with Parkinson disease(PwP) Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP |
| FG002 | 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 |
| FG003 | 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 Multifunctional RehabilitationDevice (MRD): Multifunctional rehabilitation device to treat mobility and cognitive problems in PwP |
| FG004 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Completed Data Collection for Aim 1 |
| |||||||||||||
| Completed Data Collection for Aim 2 |
| |||||||||||||
| Completed Aim 3 - Research Device Arm |
| |||||||||||||
| Completed Aim 3 - Alternate Device Arm |
| |||||||||||||
| Completed Aim 3 - No Device Arm |
|
Participants could complete any combination of aims for this study. 37 unique individuals in total participated in the study, 29 of which participated in a single aim, and 8 of which participated in more than one aim. 6 participants participated in 2 aims, and 2 participants participated in all 3 aims. The "Overall Number of Baseline Participants" represents the TOTAL number of participants to participate in each aim while baseline characteristics are reported according to participant FIRST aim.
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants Whose 1st Participation Was in Aim 1 | Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions. |
| BG001 | Participants Whose First Participation Was in Aim 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | After 1-hour session using the device |
|
For the randomized portion, data was collected for the 12 weeks of device testing. But for those participants who were involved in lab testing , data would be gathered over 1 week (2 visits) for those involved in substudy 1, and over 2 weeks for those involved in substudy 2.
Adverse event data are presented according to each aim of the study. There was 1 arm for both aims 1 and 2, and 3 arms for aim 3. Some subjects participated in multiple aims.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aim 1: 2-session In-lab Feasibility Testing of Research Device in People With Parkinson Disease(PwP) | Multifunctional rehabilitation device for PwP for human user acceptance testing for 2 lab sessions. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transient ischemic attack (TIA) | Vascular disorders | Systematic Assessment | Unrelated to study, serious and unexpected AE. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | Musculoskeletal and connective tissue disorders | Systematic Assessment | Probably related, mild, expected AE |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chatkaew Pongmala, PhD | University of Michigan | 734-936-1168 | pchatkae@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 18, 2024 | Jun 26, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 17, 2023 | Jan 30, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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.
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|
| existing standard rehabilitation device | Device | existing standard rehabilitation device to be used for in-home comparison testing for aim 3 |
|
| (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 |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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Multifunctional rehabilitation device for PwP for human user acceptance testing for 5 lab sessions.
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | 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. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | 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. | Count of Participants | Participants |
|
| Race (NIH/OMB) | 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. | Count of Participants | Participants |
|
| Region of Enrollment | Some participants were recruited to participate in more than one aim of the study. "Overall Number of Baseline Participants" represents the total number of individuals enrolled in each arm. The number analyzed here represents the total number of participants whose FIRST participation was in each respective arm. | Count of Participants | Participants |
|
| (Aim 3) Mean time to complete the Timed Up and Go test (TUG) | Mobility test that evaluates the amount of time it takes the participants to stand, walk 3 meters, turn around, walk, and sit back down. Improved performance is indicated by lower time to complete measured in seconds. | Only participant data from the Aim 3 arms were analyzed for this measure. In each arm of Aim 3, 1 participant withdrew from the study prior to testing. The Number Analyzed for this measure represents the TOTAL number of participants to undergo this testing for Aim 3, regardless of which aim they first participated in. | Mean | Standard Deviation | seconds |
|
| (Aim 3) Mean time to complete the Instrumented Stand up and Walk Test (iSAW) | 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. | Only participant data from the Aim 3 arms were analyzed for this measure. In each arm of Aim 3, 1 participant withdrew from the study prior to testing. The Number Analyzed for this measure represents the TOTAL number of participants to undergo this testing for Aim 3, regardless of which aim they first participated in. | Mean | Standard Deviation | seconds |
|
| (Aim 3) 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. | Only participant data from the Aim 3 arms were analyzed for this measure. In each arm of Aim 3, 1 participant withdrew from the study prior to testing. The Number Analyzed for this measure represents the TOTAL number of participants to undergo this testing for Aim 3, regardless of which aim they first participated in. | Mean | Standard Deviation | units on a scale |
|
| (Aim 3) Mean Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III Score | The 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. | Only participant data from the Aim 3 arms were analyzed for this measure. In each arm of Aim 3, 1 participant withdrew from the study prior to testing. The Number Analyzed for this measure represents the TOTAL number of participants to undergo this testing for Aim 3, regardless of which aim they first participated in. | Mean | Standard Deviation | units on a scale |
|
| (Aim 3) Mean Modified Hoehn and Yahr stage | 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). | Only participant data from the Aim 3 arms were analyzed for this measure. In each arm of Aim 3, 1 participant withdrew from the study prior to testing. The Number Analyzed for this measure represents the TOTAL number of participants to undergo this testing for Aim 3, regardless of which aim they first participated in. | Mean | Standard Deviation | units on a scale |
|
| (Aim 3) 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. 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). | Only participant data from the Aim 3 arms were analyzed for this measure. In each arm of Aim 3, 1 participant withdrew from the study prior to testing. The Number Analyzed for this measure represents the TOTAL number of participants to undergo this testing for Aim 3, regardless of which aim they first participated in. | Mean | Standard Deviation | seconds |
|
| (Aim 3) Mean 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). | Only participant data from the Aim 3 arms were analyzed for this measure. In each arm of Aim 3, 1 participant withdrew from the study prior to testing. The Number Analyzed for this measure represents the TOTAL number of participants to undergo this testing for Aim 3, regardless of which aim they first participated in. | Mean | Standard Deviation | seconds |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
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| 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. | Posted | Mean | Standard Deviation | score on a scale | After 1-hour session using the device |
|
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|
| 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. | Posted | Mean | Standard Deviation | score on a scale | After 1-hour session using the device |
|
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| 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. | Posted | Mean | Standard Deviation | seconds | After 2-week intervention |
|
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|
|
| 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. | 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. | Posted | Mean | Standard Deviation | seconds | After 2-week intervention |
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| 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. | Posted | Mean | Standard Deviation | seconds | After 2-week intervention |
|
|
|
|
| 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). | Posted | Mean | Standard Deviation | seconds | After 2-week intervention |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | seconds | After 14-week intervention |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | seconds | After 14-week intervention |
|
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|
| 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. | Posted | Mean | Standard Deviation | units on a scale | After 14-week intervention |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | After 14-week intervention |
|
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|
|
| 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). | Posted | Mean | Standard Deviation | score on a scale | At baseline (descriptive statistic) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | seconds | After 14-week intervention |
|
|
|
|
| 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). | Posted | Mean | Standard Deviation | seconds | After 14-week intervention |
|
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|
| 0 |
| 18 |
| 0 |
| 18 |
| 1 |
| 18 |
| EG001 | Aim 2: 5-session In-lab Feasibility Testing of Research Device in People With Parkinson Disease(PwP) | Multifunctional rehabilitation device for PwP for human user acceptance testing for 5 lab sessions. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | Aim 3: In-home Feasibility 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. | 0 | 7 | 0 | 7 | 7 | 7 |
| EG003 | Aim 3: In-home Feasibility 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 | 0 | 7 | 0 | 7 | 6 | 7 |
| EG004 | Aim 3: In-home Feasibility 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. | 0 | 7 | 1 | 7 | 4 | 7 |
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| Musculoskeletal Discomfort | Musculoskeletal and connective tissue disorders | Systematic Assessment | Probably related, mild, expected AE |
|
| Dizziness | Cardiac disorders | Systematic Assessment | Related, mild, expected AE |
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| Intercurrent Illness | General disorders | Systematic Assessment | Unrelated, mild, unexpected AE |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment | Related, mild, expected AE |
|
| Eye Strain | Eye disorders | Systematic Assessment | Unrelated, mild, unexpected AE |
|
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
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|
| ANCOVA |
Estimated difference between groups (research device group and no device group) controlling for pre-trial measurements, gender, and age. |
| 0.50 |
A priori threshold for statistical significance was p < 0.05 |
| Mean Difference (Net) |
| 0.57 |
| 2-Sided |
| Superiority |
|
| ANCOVA |
Estimated difference between groups (research device and no device group) controlling for pre-trial measurements, gender, and age. |
| 0.479 |
A priori threshold for statistical significance was p < 0.05 |
| Mean Difference (Net) |
| -1.25 |
| 2-Sided |
| Superiority |
|
| ANCOVA |
Estimated difference between groups (research device and no device group) controlling for pre-trial measurements, gender, and age. |
| 0.729 |
A priori threshold for statistical significance was p < 0.05 |
| Mean Difference (Net) |
| -0.039 |
| 2-Sided |
| Superiority |
|
| ANCOVA |
Estimated difference between groups (research device and no device group) controlling for pre-trial measurements, gender, and age. |
| 0.718 |
A priori threshold for statistical significance was p < 0.05 |
| Mean Difference (Net) |
| -1.54 |
| 2-Sided |
| Superiority |
|
| ANCOVA |
Estimated difference between groups (research device and no device group) controlling for pre-trial measurements, gender, and age. |
| 0.985 |
A priori threshold for statistical significance was p < 0.05 |
| Mean Difference (Net) |
| -0.0048 |
| 2-Sided |
| Superiority |
|
| ANCOVA |
Estimated difference between groups (research device and no device group) controlling for pre-trial measurements, gender, and age. |
| 0.51 |
A priori threshold for statistical significance was p < 0.05 |
| Mean Difference (Net) |
| 8.16 |
| 2-Sided |
| Superiority |