Parkinson DiseaseNCT06573762
Home-Based Monitoring in Parkinson's Disease
An observational study of Parkinson Disease, run by Jacob E. Simmering at 1 site in United States.
Trial summary
The goal of this observational study is to learn about the usefulness of automated analysis of speech, physical activity measures tracked using wearable devices at home, and tremor detection measured using computer-vision analysis of smartphone video to detect impairments related to Parkinson's disease and improve… Read more about this study
- Who is it for?
- Ages 50 to 110 years
- Conditions the study is for
- Parkinson Disease
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2025to 1 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be drawn from the patients seen at the UIHC Movement Disorders Clinic.
Who may be able to join
- 1. Newly referred to UIHC Movement Disorders Clinic
- Patient of UIHC Movement Disorders Clinic
- Diagnosed with Parkinson's disease
Who cannot join
- Prior diagnosis of Parkinson's disease
- Confined to wheelchair or bed
- Non-English speaking
- Prisoner status
- Inability to provide own informed consent
- Phone unable to support the Fitbit app
Show all 13Show fewer
- Group 2: People with a recent diagnosis of Parkinson's disease
- First diagnosed > 6 months ago
- Confined to wheelchair or bed
- Non-English speaking
- Prisoner status
- Inability to provide own informed consent
- Phone unable to support the Fitbit app
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shelby Francis, PhD contact
United States1 site, 1 recruiting
- Recruiting
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Jacob Simmering, PhD, 3196788037, jacob-simmering@uiowa.edu
About this study
Official title: Remote Monitoring Using Commercially Available Activity Trackers and Computer Vision Provides a Holistic, Low-cost Assessment of Parkinson's Disease Symptoms
The goal of this observational study is to learn about the usefulness of automated analysis of speech, physical activity measures tracked using wearable devices at home, and tremor detection measured using computer-vision analysis of smartphone video to detect impairments related to Parkinson's disease and improve prediction of one-year progression.
Participants will attend a short research visit at the University of Iowa. During this visit, they will make a video recording using a smartphone of them performing a fine motor task and audio recordings of pre-written text. They will be provided with an activity tracker and asked to wear it at home for four weeks. After four weeks, a video visit will be conducted and the speech and video tasks will be repeated.
Read the detailed description
Two groups of participants will be recruited. Group 1 will be patients newly referred to the Movement Disorders clinic for evaluation of possible Parkinson's disease. Group 2 will be patients with a recent (within 6 months) diagnosis of Parkinson's disease.
Group 1 (Newly Referred) will attend a baseline visit where the following data will be collected:
- Unified Parkinson's Disease Rating Scale (UPDRS). The motor assessment tasks will be recorded using an iPad.
- Montreal Cognitive Assessment (MoCA).
- Cognitive function assessment using NIH Toolbox.
- Diagnosis made at the Movement Disorders Clinic (PD or not PD).
- SF-20 quality of life assessment. (Short Form 20)
- PDQ-39 quality-of-life assessment. (Parkinson's Disease Questionnaire 39)
- Tongue and lip strength using the Iowa Oral Pressure Instrument.
- Cognitive function assessment using NIH Toolbox.
- Audio recordings of:
- Diadochokinesis (DDK) assessment.
- Vowel prolongation assessment.
- Sentence Intelligibility Test.
- Reading the Grandfather, Bamboo, and Rainbow passages.
- Recording of conversational speech.
Participants will be provided with an activity tracker and a research team member will help install any required apps on the participant's phone, configure and connect the activity tracker, provide a basic overview of how the app and tracker work, and answer any additional questions the participant may have.
The participant will then wear the activity tracker at home for 4 weeks. Text messages reminders will be sent following days with non-wear (no recorded heart rate or steps for multiple hours throughout the day) as a reminder to increase wear time.
At 4 weeks, the participant will complete a video visit using Microsoft Teams/Zoom with a study team member and the study participant. During the video visit, a recording of three different fine-motor skill tasks used in the UPDRS will be made. During the call, the study team member will provide coaching and direct the participant to repeat the audio and UPDRS fine motor task assessment at home while recording the video visit. At the end of the video visit, research team member will also collect questions about the ease and willingness to use the activity tracker and video call for disease monitoring and any open-ended comments the participant wishes to provide. This concludes the participants involvement in the study.
Group 2 (Recently Diagnosed) will attend a baseline visit where the following data will be collected:
- Unified Parkinson's Disease Rating Scale (UPDRS). The motor assessment tasks will be recorded using an iPad.
- Montreal Cognitive Assessment (MoCA).
- Cognitive function assessment using NIH Toolbox.
- Diagnosis made at the Movement Disorders Clinic (PD or not PD).
- SF-20 quality of life assessment.
- PDQ-39 quality-of-life assessment.
- Tongue and lip strength using the Iowa Oral Pressure Instrument.
- Cognitive function assessment using NIH Toolbox.
- Audio recordings of:
- Diadochokinesis (DDK) assessment.
- Vowel prolongation assessment.
- Sentence Intelligibility Test.
- Reading the Grandfather, Bamboo, and Rainbow passages.
- Recording of conversational speech.
Participants will be provided with an activity tracker and a research team member will help install any required apps on the participant's phone, configure and connect the activity tracker, provide a basic overview of how the app and tracker work, and answer any additional questions the participant may have.
The participant will then wear the activity tracker at home for 4 weeks. Text messages reminders will be sent following days with non-wear (no recorded heart rate or steps for multiple hours throughout the day) as a reminder to increase wear time.
At 4 weeks, the participant will complete a video visit using Microsoft Teams/Zoom with a study team member and the study participant. During the video visit, a recording of three different fine-motor skill tasks used in the UPDRS will be made. During the call, the study team member will provide coaching and direct the participant to repeat the audio and UPDRS fine motor task assessment at home while recording the video visit. At the end of the video visit, research team member will also collect questions about the ease and willingness to use the activity tracker and video call for disease monitoring and any open-ended comments the participant wishes to provide.
At 11 months, the participant will be contacted to schedule a one-year research visit. Many patients return on 3-6 month intervals to the UIHC Movement Disorders Clinic and the research visit will ideally coordinate the participants routine visit for care.
At the one-year encounter, which will be an in-person research visit, the following data elements will be collected:
- Unified Parkinson's Disease Rating Scale (UPDRS).
- Montreal Cognitive Assessment (MoCA).
- Cognitive function assessment using NIH Toolbox.
- SF-20.
- PDQ-39 quality-of-life assessment.
Additionally, the research team will solicit any open-ended feedback the participant wants to share with the study team about their experience being in the study.
- Conditions
- Parkinson Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Recently Referred for Possible Parkinson's Disease | Patients referred to the University of Iowa Hospitals and Clinics (UIHC) Movement Disorders Clinic for possible Parkinson's disease. | |
| Recently Diagnosed with Parkinson's Disease | Patients of the UIHC Movement Disorders Clinic with a recent (less than 6 months) diagnosis of Parkinson's disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with a Diagnosis of Parkinson's Disease
Among Group 1 (those newly referred to the clinic for possible Parkinson's disease), a primary outcome will be whether the diagnosis made by the provider in the clinic was Parkinson's disease versus any other diagnosis.
This is not an outcome for Group 2 (those with a recent diagnosis of Parkinson's disease) as everyone in that group will have that diagnosis.
Measured: Baseline
Change in Fine Motor Function
Motor function will be evaluated using the UPDRS rating system.
Measured: Baseline, One Year
Change in Total Cognition Composite Function
Total Cognition Composite will be calculated using the NIH Toolbox Cognition Battery. This score has a range from 0 to 200 with healthy adults having a mean score of 100 with a standard deviation of 15. Higher scores are associated with better cognitive performance.
Measured: Baseline, One Year
Change in Total Crystallized Cognition Function
Crystallized Cognition Composite will be calculated using the NIH Toolbox Cognition Battery. This score has a range from 0 to 200 with healthy adults having a mean score of 100 with a standard deviation of 15. Higher scores are associated with better cognitive performance.
Measured: Baseline, One Year
Change in Total Fluid Cognition Function
Fluid Cognition Composite will be calculated using the NIH Toolbox Cognition Battery. This score has a range from 0 to 200 with healthy adults having a mean score of 100 with a standard deviation of 15. Higher scores are associated with better cognitive performance.
Measured: Baseline, One Year
Change in Montreal Cognitive Assessment Scores
The Montreal Cognitive Assessment (MoCA) has a range of 0-30. Higher scores are associated with better cognitive function. Scores of 26 or higher are considered cognitively normal. Scores less than 26 are suggestive of cognitive impairment, with dementia scores being below 20 but without a universally-accepted cutoff.
Measured: Baseline, One Year
Secondary outcomes (2)
Change in Short Form Survey 20 (SF-20) Health Quality of Life
Health related quality of life will me measured using the Short Form Survey 20 (SF-20). SF-20 scores range from 0 to 100 with higher scores having greater quality-of-life.
Measured: Baseline, One Year
Change in Parkinson's Disease Questionnaire 39 (PDQ-39) Quality of Life
Health related quality of life will me measured using the Parkinson's Disease Questionnaire 39 (PDQ-39). PDQ-39 scores range from 0 to 156 with lower scores reflecting less Parkinson's disease burden and higher scores associated with greater disease burden.
Measured: Baseline, One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start7 Apr 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jacob E. Simmering
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jacob E. Simmering, University of Iowa
- Investigators
- Jacob Simmering, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573762
- Sponsor's protocol ID
- 202308199
- Status last verified
- Apr 2025
- First submitted
- 21 Aug 2024
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be deposited in the National Archive of Computerized Data on Aging (NACDA). Analytical code and documentation of study procedures will be shared both via the NACDA record and via GitHub repositories.
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Monitoring Using Commercially Available Activity Trackers and Computer Vision Provides a Holistic, Low-cost Assessment of Parkinson's Disease Symptoms
- ClinicalTrials.gov ID
- NCT06573762
- Acronym / sponsor ID
- 202308199
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Jacob E. SimmeringUniversity, hospital or other
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 27 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn about the usefulness of automated analysis of speech, physical activity measures tracked using wearable devices at home, and tremor detection measured using computer-vision analysis of smartphone video to detect impairments related to Parkinson's disease and improve prediction of one-year progression.
Participants will attend a short research visit at the University of Iowa. During this visit, they will make a video recording using a smartphone of them performing a fine motor task and audio recordings of pre-written text. They will be provided with an activity tracker and asked to wear it at home for four weeks. After four weeks, a video visit will be conducted and the speech and video tasks will be repeated.
Detailed description
Two groups of participants will be recruited. Group 1 will be patients newly referred to the Movement Disorders clinic for evaluation of possible Parkinson's disease. Group 2 will be patients with a recent (within 6 months) diagnosis of Parkinson's disease.
Group 1 (Newly Referred) will attend a baseline visit where the following data will be collected:
- Unified Parkinson's Disease Rating Scale (UPDRS). The motor assessment tasks will be recorded using an iPad.
- Montreal Cognitive Assessment (MoCA).
- Cognitive function assessment using NIH Toolbox.
- Diagnosis made at the Movement Disorders Clinic (PD or not PD).
- SF-20 quality of life assessment. (Short Form 20)
- PDQ-39 quality-of-life assessment. (Parkinson's Disease Questionnaire 39)
- Tongue and lip strength using the Iowa Oral Pressure Instrument.
- Cognitive function assessment using NIH Toolbox.
- Audio recordings of:
- Diadochokinesis (DDK) assessment.
- Vowel prolongation assessment.
- Sentence Intelligibility Test.
- Reading the Grandfather, Bamboo, and Rainbow passages.
- Recording of conversational speech.
Participants will be provided with an activity tracker and a research team member will help install any required apps on the participant's phone, configure and connect the activity tracker, provide a basic overview of how the app and tracker work, and answer any additional questions the participant may have.
The participant will then wear the activity tracker at home for 4 weeks. Text messages reminders will be sent following days with non-wear (no recorded heart rate or steps for multiple hours throughout the day) as a reminder to increase wear time.
At 4 weeks, the participant will complete a video visit using Microsoft Teams/Zoom with a study team member and the study participant. During the video visit, a recording of three different fine-motor skill tasks used in the UPDRS will be made. During the call, the study team member will provide coaching and direct the participant to repeat the audio and UPDRS fine motor task assessment at home while recording the video visit. At the end of the video visit, research team member will also collect questions about the ease and willingness to use the activity tracker and video call for disease monitoring and any open-ended comments the participant wishes to provide. This concludes the participants involvement in the study.
Group 2 (Recently Diagnosed) will attend a baseline visit where the following data will be collected:
- Unified Parkinson's Disease Rating Scale (UPDRS). The motor assessment tasks will be recorded using an iPad.
- Montreal Cognitive Assessment (MoCA).
- Cognitive function assessment using NIH Toolbox.
- Diagnosis made at the Movement Disorders Clinic (PD or not PD).
- SF-20 quality of life assessment.
- PDQ-39 quality-of-life assessment.
- Tongue and lip strength using the Iowa Oral Pressure Instrument.
- Cognitive function assessment using NIH Toolbox.
- Audio recordings of:
- Diadochokinesis (DDK) assessment.
- Vowel prolongation assessment.
- Sentence Intelligibility Test.
- Reading the Grandfather, Bamboo, and Rainbow passages.
- Recording of conversational speech.
Participants will be provided with an activity tracker and a research team member will help install any required apps on the participant's phone, configure and connect the activity tracker, provide a basic overview of how the app and tracker work, and answer any additional questions the participant may have.
The participant will then wear the activity tracker at home for 4 weeks. Text messages reminders will be sent following days with non-wear (no recorded heart rate or steps for multiple hours throughout the day) as a reminder to increase wear time.
At 4 weeks, the participant will complete a video visit using Microsoft Teams/Zoom with a study team member and the study participant. During the video visit, a recording of three different fine-motor skill tasks used in the UPDRS will be made. During the call, the study team member will provide coaching and direct the participant to repeat the audio and UPDRS fine motor task assessment at home while recording the video visit. At the end of the video visit, research team member will also collect questions about the ease and willingness to use the activity tracker and video call for disease monitoring and any open-ended comments the participant wishes to provide.
At 11 months, the participant will be contacted to schedule a one-year research visit. Many patients return on 3-6 month intervals to the UIHC Movement Disorders Clinic and the research visit will ideally coordinate the participants routine visit for care.
At the one-year encounter, which will be an in-person research visit, the following data elements will be collected:
- Unified Parkinson's Disease Rating Scale (UPDRS).
- Montreal Cognitive Assessment (MoCA).
- Cognitive function assessment using NIH Toolbox.
- SF-20.
- PDQ-39 quality-of-life assessment.
Additionally, the research team will solicit any open-ended feedback the participant wants to share with the study team about their experience being in the study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recently Referred for Possible Parkinson's Disease | – | –Patients referred to the University of Iowa Hospitals and Clinics (UIHC) Movement Disorders Clinic for possible Parkinson's disease. |
| Recently Diagnosed with Parkinson's Disease | – | –Patients of the UIHC Movement Disorders Clinic with a recent (less than 6 months) diagnosis of Parkinson's disease. |
Who may qualify
- Ages
- 50 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be drawn from the patients seen at the UIHC Movement Disorders Clinic.
Key inclusion criteria (3 listed)
- 1. Newly referred to UIHC Movement Disorders Clinic
- Patient of UIHC Movement Disorders Clinic
- Diagnosed with Parkinson's disease
Key exclusion criteria (13 listed)
- Prior diagnosis of Parkinson's disease
- Confined to wheelchair or bed
- Non-English speaking
- Prisoner status
- Inability to provide own informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Patients with a Diagnosis of Parkinson's Disease
Time frame: Baseline
Among Group 1 (those newly referred to the clinic for possible Parkinson's disease), a primary outcome will be whether the diagnosis made by the provider in the clinic was Parkinson's disease versus any other diagnosis. This is not an outcome for Group 2 (those with a recent diagnosis of Parkinson's disease) as everyone in that group will have that diagnosis.
Change in Fine Motor Function
Time frame: Baseline, One Year
Motor function will be evaluated using the UPDRS rating system.
Change in Total Cognition Composite Function
Time frame: Baseline, One Year
Total Cognition Composite will be calculated using the NIH Toolbox Cognition Battery. This score has a range from 0 to 200 with healthy adults having a mean score of 100 with a standard deviation of 15. Higher scores are associated with better cognitive performance.
Change in Total Crystallized Cognition Function
Time frame: Baseline, One Year
Crystallized Cognition Composite will be calculated using the NIH Toolbox Cognition Battery. This score has a range from 0 to 200 with healthy adults having a mean score of 100 with a standard deviation of 15. Higher scores are associated with better cognitive performance.
Change in Total Fluid Cognition Function
Time frame: Baseline, One Year
Fluid Cognition Composite will be calculated using the NIH Toolbox Cognition Battery. This score has a range from 0 to 200 with healthy adults having a mean score of 100 with a standard deviation of 15. Higher scores are associated with better cognitive performance.
Change in Montreal Cognitive Assessment Scores
Time frame: Baseline, One Year
The Montreal Cognitive Assessment (MoCA) has a range of 0-30. Higher scores are associated with better cognitive function. Scores of 26 or higher are considered cognitively normal. Scores less than 26 are suggestive of cognitive impairment, with dementia scores being below 20 but without a universally-accepted cutoff.
2 secondary outcomes
Change in Short Form Survey 20 (SF-20) Health Quality of Life
Time frame: Baseline, One Year
Change in Parkinson's Disease Questionnaire 39 (PDQ-39) Quality of Life
Time frame: Baseline, One Year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Individual participant dataSharing planned: Yes. De-identified data will be deposited in the National Archive of Computerized Data on Aging (NACDA). Analytical code and documentation of study procedures will be shared both via the NACDA record and via GitHub repositories.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shelby Francis, PhD contact
Jacob Simmering, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Jacob E. Simmering at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacob Simmering, MS, PHD, BA (3196788037, jacob-simmering@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients with a Diagnosis of Parkinson's Disease (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.