Remote Monitoring Using Commercially Available Activity Trackers and Computer Vision Provides a Holistic, Low-cost Assessment of Parkinson's Disease Symptoms
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Number of Patients with a Diagnosis of Parkinson's Disease
Study Overview
Brief 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 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:
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Unified Parkinson's Disease Rating Scale (UPDRS). The motor assessment tasks will be recorded using an iPad.
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Montreal Cognitive Assessment (MoCA).
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Cognitive function assessment using NIH Toolbox.
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Diagnosis made at the Movement Disorders Clinic (PD or not PD).
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SF-20 quality of life assessment. (Short Form 20)
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PDQ-39 quality-of-life assessment. (Parkinson's Disease Questionnaire 39)
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Tongue and lip strength using the Iowa Oral Pressure Instrument.
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Cognitive function assessment using NIH Toolbox.
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Audio recordings of:
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Diadochokinesis (DDK) assessment.
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Vowel prolongation assessment.
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Sentence Intelligibility Test.
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Reading the Grandfather, Bamboo, and Rainbow passages.
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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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 50 Years to 110 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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 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 Fine Motor Function
Time Frame: Baseline, One Year
Motor function will be evaluated using the UPDRS rating system.
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 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 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.
Secondary Outcomes
- Change in Parkinson's Disease Questionnaire 39 (PDQ-39) Quality of Life(Baseline, One Year)
- Change in Short Form Survey 20 (SF-20) Health Quality of Life(Baseline, One Year)
Investigators
Jacob E. Simmering
Assistant Professor
University of Iowa