Development of a Multifunctional Rehabilitation Device for Persons With Parkinson's Disease
NCT05586490, Not applicable, Completed, University of Michigan; results first posted 2025-01-14
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Development of a Multifunctional Rehabilitation Device for Persons With Parkinson's Disease | ClinicalTrials.gov |
| NCT number | NCT05586490 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 38 participants, actual | ClinicalTrials.gov |
| Lead sponsor | University of Michigan | ClinicalTrials.gov |
| Conditions | Parkinson Disease | ClinicalTrials.gov |
| Interventions | Multifunctional RehabilitationDevice (MRD), existing standard rehabilitation device | ClinicalTrials.gov |
| First posted | 2022-10-19 | ClinicalTrials.gov |
| Last updated | 2025-01-14 | ClinicalTrials.gov |
| Results first posted | 2025-01-14 | ClinicalTrials.gov |
Registered outcomes 14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | (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. | ClinicalTrials.gov |
| Primary | (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. | ClinicalTrials.gov |
| Primary | (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. | ClinicalTrials.gov |
| Primary | (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. | ClinicalTrials.gov |
| Primary | (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. | ClinicalTrials.gov |
| Primary | (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. | ClinicalTrials.gov |
| Primary | (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). | ClinicalTrials.gov |
| 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. | 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. | ClinicalTrials.gov |
| 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. | 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. | ClinicalTrials.gov |
| Primary | (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. | ClinicalTrials.gov |
| 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. | 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. | ClinicalTrials.gov |
| Primary | (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). | ClinicalTrials.gov |
| Primary | (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. | ClinicalTrials.gov |
| 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. | 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). | ClinicalTrials.gov |
Outcomes 14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | (Aim 1) Mean of User Acceptance Questionnaire (UAQ) Part 1 Total Scores | After 1-hour session using the device | score on a scale | MEAN | ClinicalTrials.gov | |
| PRIMARY | (Aim 1) Mean of User Acceptance Questionnaire (UAQ) Part 2 Total Scores | After 1-hour session using the device | score on a scale | MEAN | ClinicalTrials.gov | |
| PRIMARY | (Aim 1) Mean System Usability Scale (SUS) Total Scores | After 1-hour session using the device | score on a scale | MEAN | ClinicalTrials.gov | |
| PRIMARY | (Aim 2) Change in Mean Time to Complete the Instrumented Timed Up and Go Test (iTUG) | After 2-week intervention | seconds | MEAN | ClinicalTrials.gov | |
| PRIMARY | (Aim 2) Change in Mean Duration of Balance During Romberg Test Condition | After 2-week intervention | 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. | seconds | MEAN | ClinicalTrials.gov |
| PRIMARY | (Aim 2) Change in Mean Response Time During the Stroop Stepping Test | After 2-week intervention | seconds | MEAN | ClinicalTrials.gov | |
| PRIMARY | (Aim 2) Change in Mean of Time Taken to Complete Stroop Color Word Interference Test | After 2-week intervention | seconds | MEAN | ClinicalTrials.gov | |
| 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. | After 14-week intervention | seconds | MEAN | ClinicalTrials.gov | |
| 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. | After 14-week intervention | seconds | MEAN | ClinicalTrials.gov | |
| PRIMARY | (Aim 3) Difference in Effect of Intervention on Sensory Postural Control Domain as Measured During the MiniBESTest. | After 14-week intervention | units on a scale | MEAN | ClinicalTrials.gov | |
| 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. | After 14-week intervention | score on a scale | MEAN | ClinicalTrials.gov | |
| PRIMARY | (Aim 3) Mean Modified Hoehn and Yahr Stage at Baseline | At baseline (descriptive statistic) | score on a scale | MEAN | ClinicalTrials.gov | |
| PRIMARY | (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 | seconds | MEAN | ClinicalTrials.gov | |
| 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. | After 14-week intervention | seconds | MEAN | ClinicalTrials.gov |
Results by group 50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| (Aim 1) Mean of User Acceptance Questionnaire (UAQ) Part 1 Total Scores | In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) | 7.28 | Standard Deviation 6.18 | score on a scale | ClinicalTrials.gov | |
| (Aim 1) Mean of User Acceptance Questionnaire (UAQ) Part 2 Total Scores | In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) | 23.72 | Standard Deviation 5.12 | score on a scale | ClinicalTrials.gov | |
| (Aim 1) Mean System Usability Scale (SUS) Total Scores | In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) | 83.19 | Standard Deviation 14.09 | score on a scale | ClinicalTrials.gov | |
| (Aim 2) Change in Mean Time to Complete the Instrumented Timed Up and Go Test (iTUG) | In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) | Pre-Intervention | 18.761 | Standard Deviation 5.651 | seconds | ClinicalTrials.gov |
| (Aim 2) Change in Mean Time to Complete the Instrumented Timed Up and Go Test (iTUG) | In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) | Post-Intervention | 18.124 | Standard Deviation 4.700 | seconds | ClinicalTrials.gov |
| (Aim 2) Change in Mean Duration of Balance During Romberg Test Condition | In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) | Pre-Intervention | 26.25 | Standard Deviation 10.61 | seconds | ClinicalTrials.gov |
| (Aim 2) Change in Mean Duration of Balance During Romberg Test Condition | In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) | Post-Intervention | 30 | Standard Deviation 0 | seconds | ClinicalTrials.gov |
| (Aim 2) Change in Mean Response Time During the Stroop Stepping Test | In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) | Pre-Intervention | 1.887 | Standard Deviation 0.27 | seconds | ClinicalTrials.gov |
| (Aim 2) Change in Mean Response Time During the Stroop Stepping Test | In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) | Post-Intervention | 1.874 | Standard Deviation 0.42 | seconds | ClinicalTrials.gov |
| (Aim 2) Change in Mean of Time Taken to Complete Stroop Color Word Interference Test | In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) | Pre-Intervention | 167.51 | Standard Deviation 55.96 | seconds | ClinicalTrials.gov |
| (Aim 2) Change in Mean of Time Taken to Complete Stroop Color Word Interference Test | In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) | Post-Intervention | 152.71 | Standard Deviation 54.54 | seconds | ClinicalTrials.gov |
| (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. | In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) | Pre-Intervention | 7.65 | Standard Deviation 1.68 | seconds | ClinicalTrials.gov |
| (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. | In-home Feasibility Testing (Alternate Device) | Pre-Intervention | 7.49 | Standard Deviation 1.12 | seconds | ClinicalTrials.gov |
| (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. | In-home Feasibility Testing (no Device in at Home Portion) | Pre-Intervention | 8.53 | Standard Deviation 1.94 | seconds | ClinicalTrials.gov |
| (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. | In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) | Post-Intervention | 8.27 | Standard Deviation 1.77 | seconds | ClinicalTrials.gov |
| (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. | In-home Feasibility Testing (Alternate Device) | Post-Intervention | 6.83 | Standard Deviation 1.42 | seconds | ClinicalTrials.gov |
| (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. | In-home Feasibility Testing (no Device in at Home Portion) | Post-Intervention | 8.47 | Standard Deviation 2.34 | seconds | ClinicalTrials.gov |
| (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. | In-lab and in Home Feasibility Testing of Research Device in People With Parkinson's Disease (PwP) | Pre-Intervention | 13.05 | Standard Deviation 1.42 | seconds | ClinicalTrials.gov |
| (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. | In-home Feasibility Testing (Alternate Device) | Pre-Intervention | 12.72 | Standard Deviation 1.81 | seconds | ClinicalTrials.gov |
| (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. | In-home Feasibility Testing (no Device in at Home Portion) | Pre-Intervention | 13.32 | Standard Deviation 2.02 | seconds | ClinicalTrials.gov |
Participant flow 75
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Completed Data Collection for Aim 1 | STARTED | Participants Whose 1st Participation Was in Aim 1 | 18 | ClinicalTrials.gov | |
| Completed Data Collection for Aim 1 | STARTED | Participants Whose First Participation Was in Aim 2 | 0 | ClinicalTrials.gov | |
| Completed Data Collection for Aim 1 | STARTED | Participants Whose 1st Participation Was in Aim 3: In-Home Testing - Research Device Arm | 0 | ClinicalTrials.gov | |
| Completed Data Collection for Aim 1 | STARTED | Participants Whose 1st Participation Was in Aim 3: In-Home Testing - Alternate Device Arm | 0 | ClinicalTrials.gov | |
| Completed Data Collection for Aim 1 | STARTED | Participants Whose 1st Participation Was in Aim 3: In-Home Testing - No Device Arm | 0 | ClinicalTrials.gov | |
| Completed Data Collection for Aim 1 | COMPLETED | Participants Whose 1st Participation Was in Aim 1 | 18 | ClinicalTrials.gov | |
| Completed Data Collection for Aim 1 | COMPLETED | Participants Whose First Participation Was in Aim 2 | 0 | ClinicalTrials.gov | |
| Completed Data Collection for Aim 1 | COMPLETED | Participants Whose 1st Participation Was in Aim 3: In-Home Testing - Research Device Arm | 0 | ClinicalTrials.gov | |
| Completed Data Collection for Aim 1 | COMPLETED | Participants Whose 1st Participation Was in Aim 3: In-Home Testing - Alternate Device Arm | 0 | ClinicalTrials.gov | |
| Completed Data Collection for Aim 1 | COMPLETED | Participants Whose 1st Participation Was in Aim 3: In-Home Testing - No Device Arm | 0 | ClinicalTrials.gov | |
| Completed Data Collection for Aim 1 | NOT COMPLETED | Participants Whose 1st Participation Was in Aim 1 | 0 | ClinicalTrials.gov | |
| Completed Data Collection for Aim 1 | NOT COMPLETED | Participants Whose First Participation Was in Aim 2 | 0 | ClinicalTrials.gov | |
| Completed Data Collection for Aim 1 | NOT COMPLETED | Participants Whose 1st Participation Was in Aim 3: In-Home Testing - Research Device Arm | 0 | ClinicalTrials.gov | |
| Completed Data Collection for Aim 1 | NOT COMPLETED | Participants Whose 1st Participation Was in Aim 3: In-Home Testing - Alternate Device Arm | 0 | ClinicalTrials.gov | |
| Completed Data Collection for Aim 1 | NOT COMPLETED | Participants Whose 1st Participation Was in Aim 3: In-Home Testing - No Device Arm | 0 | ClinicalTrials.gov | |
| Completed Data Collection for Aim 2 | STARTED | Participants Whose 1st Participation Was in Aim 1 | 4 | ClinicalTrials.gov | |
| Completed Data Collection for Aim 2 | STARTED | Participants Whose First Participation Was in Aim 2 | 4 | ClinicalTrials.gov | |
| Completed Data Collection for Aim 2 | STARTED | Participants Whose 1st Participation Was in Aim 3: In-Home Testing - Research Device Arm | 0 | ClinicalTrials.gov | |
| Completed Data Collection for Aim 2 | STARTED | Participants Whose 1st Participation Was in Aim 3: In-Home Testing - Alternate Device Arm | 0 | ClinicalTrials.gov | |
| Completed Data Collection for Aim 2 | STARTED | Participants Whose 1st Participation Was in Aim 3: In-Home Testing - No Device Arm | 0 | ClinicalTrials.gov |
Adverse events 35
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|---|---|---|---|---|---|---|
| other | Fatigue | Musculoskeletal and connective tissue disorders | Aim 1: 2-session In-lab Feasibility Testing of Research Device in People With Parkinson Disease(PwP) | 1 | 18 | ClinicalTrials.gov | |
| other | Fatigue | Musculoskeletal and connective tissue disorders | Aim 2: 5-session In-lab Feasibility Testing of Research Device in People With Parkinson Disease(PwP) | 0 | 8 | ClinicalTrials.gov | |
| other | Fatigue | Musculoskeletal and connective tissue disorders | Aim 3: In-home Feasibility Testing - Research Device Arm | 0 | 7 | ClinicalTrials.gov | |
| other | Fatigue | Musculoskeletal and connective tissue disorders | Aim 3: In-home Feasibility Testing - Alternate Device Arm | 0 | 7 | ClinicalTrials.gov | |
| other | Fatigue | Musculoskeletal and connective tissue disorders | Aim 3: In-home Feasibility Testing - No Device Arm | 0 | 7 | ClinicalTrials.gov | |
| other | Musculoskeletal Discomfort | Musculoskeletal and connective tissue disorders | Aim 1: 2-session In-lab Feasibility Testing of Research Device in People With Parkinson Disease(PwP) | 0 | 18 | ClinicalTrials.gov | |
| other | Musculoskeletal Discomfort | Musculoskeletal and connective tissue disorders | Aim 2: 5-session In-lab Feasibility Testing of Research Device in People With Parkinson Disease(PwP) | 0 | 8 | ClinicalTrials.gov | |
| other | Musculoskeletal Discomfort | Musculoskeletal and connective tissue disorders | Aim 3: In-home Feasibility Testing - Research Device Arm | 3 | 7 | ClinicalTrials.gov | |
| other | Musculoskeletal Discomfort | Musculoskeletal and connective tissue disorders | Aim 3: In-home Feasibility Testing - Alternate Device Arm | 2 | 7 | ClinicalTrials.gov | |
| other | Musculoskeletal Discomfort | Musculoskeletal and connective tissue disorders | Aim 3: In-home Feasibility Testing - No Device Arm | 2 | 7 | ClinicalTrials.gov | |
| other | Dizziness | Cardiac disorders | Aim 1: 2-session In-lab Feasibility Testing of Research Device in People With Parkinson Disease(PwP) | 0 | 18 | ClinicalTrials.gov | |
| other | Dizziness | Cardiac disorders | Aim 2: 5-session In-lab Feasibility Testing of Research Device in People With Parkinson Disease(PwP) | 0 | 8 | ClinicalTrials.gov | |
| other | Dizziness | Cardiac disorders | Aim 3: In-home Feasibility Testing - Research Device Arm | 2 | 7 | ClinicalTrials.gov | |
| other | Dizziness | Cardiac disorders | Aim 3: In-home Feasibility Testing - Alternate Device Arm | 1 | 7 | ClinicalTrials.gov | |
| other | Dizziness | Cardiac disorders | Aim 3: In-home Feasibility Testing - No Device Arm | 0 | 7 | ClinicalTrials.gov | |
| other | Intercurrent Illness | General disorders | Aim 1: 2-session In-lab Feasibility Testing of Research Device in People With Parkinson Disease(PwP) | 0 | 18 | ClinicalTrials.gov | |
| other | Intercurrent Illness | General disorders | Aim 2: 5-session In-lab Feasibility Testing of Research Device in People With Parkinson Disease(PwP) | 0 | 8 | ClinicalTrials.gov | |
| other | Intercurrent Illness | General disorders | Aim 3: In-home Feasibility Testing - Research Device Arm | 1 | 7 | ClinicalTrials.gov | |
| other | Intercurrent Illness | General disorders | Aim 3: In-home Feasibility Testing - Alternate Device Arm | 2 | 7 | 3 | ClinicalTrials.gov |
| other | Intercurrent Illness | General disorders | Aim 3: In-home Feasibility Testing - No Device Arm | 1 | 7 | ClinicalTrials.gov |
Adverse event totals 15
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Aim 1: 2-session In-lab Feasibility Testing of Research Device in People With Parkinson Disease(PwP) | 0 | 18 | ClinicalTrials.gov |
| Total, all-cause mortality | Aim 2: 5-session In-lab Feasibility Testing of Research Device in People With Parkinson Disease(PwP) | 0 | 8 | ClinicalTrials.gov |
| Total, all-cause mortality | Aim 3: In-home Feasibility Testing - Research Device Arm | 0 | 7 | ClinicalTrials.gov |
| Total, all-cause mortality | Aim 3: In-home Feasibility Testing - Alternate Device Arm | 0 | 7 | ClinicalTrials.gov |
| Total, all-cause mortality | Aim 3: In-home Feasibility Testing - No Device Arm | 0 | 7 | ClinicalTrials.gov |
| Total, other adverse events | Aim 1: 2-session In-lab Feasibility Testing of Research Device in People With Parkinson Disease(PwP) | 1 | 18 | ClinicalTrials.gov |
| Total, other adverse events | Aim 2: 5-session In-lab Feasibility Testing of Research Device in People With Parkinson Disease(PwP) | 0 | 8 | ClinicalTrials.gov |
| Total, other adverse events | Aim 3: In-home Feasibility Testing - Research Device Arm | 7 | 7 | ClinicalTrials.gov |
| Total, other adverse events | Aim 3: In-home Feasibility Testing - Alternate Device Arm | 6 | 7 | ClinicalTrials.gov |
| Total, other adverse events | Aim 3: In-home Feasibility Testing - No Device Arm | 4 | 7 | ClinicalTrials.gov |
| Total, serious adverse events | Aim 1: 2-session In-lab Feasibility Testing of Research Device in People With Parkinson Disease(PwP) | 0 | 18 | ClinicalTrials.gov |
| Total, serious adverse events | Aim 2: 5-session In-lab Feasibility Testing of Research Device in People With Parkinson Disease(PwP) | 0 | 8 | ClinicalTrials.gov |
| Total, serious adverse events | Aim 3: In-home Feasibility Testing - Research Device Arm | 0 | 7 | ClinicalTrials.gov |
| Total, serious adverse events | Aim 3: In-home Feasibility Testing - Alternate Device Arm | 0 | 7 | ClinicalTrials.gov |
| Total, serious adverse events | Aim 3: In-home Feasibility Testing - No Device Arm | 1 | 7 | ClinicalTrials.gov |
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)