What Digital Measures Are Really Capturing in Parkinson’s Disease and Why It Matters for Clinical Trials
- Koneksa Health
- Apr 9
- 5 min read
Insights from new peer-reviewed research by Koneksa during Parkinson's Awareness Month
Behind Every Dataset is a Lived Experience.
In Parkinson’s disease, symptoms do not progress in neat, linear steps. They can fluctuate hour to hour and day to day, often in ways that are difficult to fully understand through episodic clinic-based assessment alone. That is one reason the field continues to explore how digital tools, patient input, and functional measures can strengthen the way disease impact is assessed over time.
As we recognize Parkinson’s Awareness Month in April and World Parkinson’s Day on April 11, it is an important time to focus on research that brings measurement closer to lived patient experience.
A new peer-reviewed publication in Frontiers in Neurology co-authored by Robert Ellis, PhD, Koneksa co-founder and Head of Biomarker Exploration, with collaborators from Sanofi, contributes to that effort. The paper examines which aspects of Parkinson’s disease (PD) are most meaningful to patients and clinicians when developing a digital assessment approach for Parkinson’s disease functional impacts.
What the Research Explored
The paper was designed to identify the PD symptoms and functional impacts that are most relevant and meaningful to assess as part of the Parkinson’s Disease Functional Impacts Digital Instrument, or PD-FIDI. PD-FIDI is described in the paper as a smartphone app and wrist-worn wearable based digital endpoint instrument intended to remotely measure Parkinson’s disease functional impacts, including severity, progression, and functional change. To do this, the authors combined three inputs:
an advisory panel of eight clinical experts
a literature review of qualitative studies reporting patient perspectives
an online survey of 202 people with documented Parkinson’s disease across 39 U.S. states, including 189 people with idiopathic PD and 13 people with GBA1-PD
This matters because the study was not just asking what can be measured with digital tools. It was asking what should be prioritized because it is meaningful to patients’ everyday lives. That distinction is important for any sponsor thinking about endpoint strategy, remote assessment, or digital biomarker development.
What the Paper Found
One of the clearest takeaways from the paper is that both clinicians and patients identified a core group of PD impacts as highly meaningful for assessment.
According to the publication, these included balance and gait difficulties, bradykinesia, global motor function difficulties, hands motor function difficulties, movement and mobility difficulties, rigidity or stiffness, and tremor.
The patient survey also highlighted how everyday function shapes disease burden. In the survey, four of the top five most significant negative everyday impacts were related to motor symptoms, including:
doing outdoor active leisure activities
moving around as quickly as I like
completing manual labor tasks
maintaining balance
The other top-five item was feeling depressed.
When patients were asked what would be most meaningful to improve, four of the top five responses were again motor-related:
moving around as quickly as I like
maintaining balance
doing outdoor active leisure activities
experiencing ON-state dyskinesias
The other top-five item was taking part in social activities with friends and loved ones.
That pattern is useful because it grounds the conversation in functional impact, not just symptom labels.
A particularly important digital measures insight:
patients and clinicians do not always prioritize the same things
The paper also found an important difference between patient and clinician perspectives. Depression and fatigue were scored highly meaningful by patients but not clinicians. The authors note that these were considered significantly more meaningful by patients than by clinicians in this study.
That is one of the strongest findings in the paper, especially for teams thinking about endpoint strategy. It reinforces that meaningful assessment design cannot rely on clinical intuition alone. Patient perspective has to be part of the development process, particularly when the goal is to understand impact in daily life.
A short line from the paper captures the point well: “Depression and fatigue were considered significantly more meaningful by patients than clinicians.”
How the Findings Informed PD-FIDI
The paper does not claim that every meaningful PD impact can already be captured digitally. Instead, it explains that the findings were used to inform PD-FIDI’s design where assessment was technically viable, operationally feasible, and safe. The publication describes PD-FIDI as including:
app-based electronic patient-reported outcome assessments of motor impacts
an app-based dyskinesia impact assessment
app-based functional motor assessments
continuous monitoring of gait, balance, physical activity, and mobility using a wrist-worn device
exploratory sleep assessments using ePRO and actigraphy-based measures
The authors also explain that some meaningful aspects were not incorporated in the same way. For example, a sit-stand balance task was excluded because of fall risk, and depression was not incorporated into PD-FIDI because of concerns about the validity of longitudinal self-report measurement in that context.
That is an important nuance. Better digital measurement is not just about adding more tasks or more data streams. It depends on choosing measures that are meaningful, feasible, and fit for purpose.
Why This Matters for Clinical Development
For clinical development teams, this paper offers a useful reminder that endpoint design should begin with the realities of disease experience. In PD, the aspects most meaningful to patients often sit at the intersection of motor function, mobility, daily activity, and quality of life. This publication is especially relevant for teams working on:
digital endpoint strategy in PD
remote and at-home assessment models
patient-centered outcome development
digital biomarker and wearable-enabled study design
It also reinforces a broader principle that applies well beyond PD: the value of digital assessment is not only in continuous or remote data collection. It is in whether the measurement approach is aligned to what is actually meaningful to patients and interpretable for clinical decision-making. This paper advances that alignment by grounding instrument design in both clinician and patient input.
Looking Ahead
The authors conclude that the findings support ongoing evaluation of PD-FIDI, including studies of its analytical validity, clinical validity, and usability. They further note that, once validated, the instrument could help track PD symptoms in a less burdensome and more objective way from the home environment.
That future-focused stance is worth preserving. This paper is best understood as a strong concept-development and prioritization study. It helps define what matters most to assess digitally in PD and how those priorities can shape a more meaningful measurement strategy.
During Parkinson’s Awareness Month, that is a timely reminder: advancing science starts with understanding which disease impacts matter most to the people living with them.
Apply These Insights to Your Study Design
If you are evaluating digital endpoints or rethinking how PD is measured in your studies, our team can help. Connect with Koneksa to explore how measurement strategy, digital assessments, and integrated analytics can support clearer, more meaningful insight in your clinical program.