Related Experiment Video
Updated: Jul 12, 2025
Home-Based Monitor for Gait and Activity Analysis
Published on: August 8, 2019
Progression events defined by home-based assessment of motor function in multiple sclerosis: protocol of a
Eva-Maria Dorsch1,2,3,4,5, Hanna Marie Röhling1,2,3,6, Dario Zocholl7
1Experimental and Clinical Research Center, a Cooperation between the Max-Delbrück-Center for Molecular Medicine in the Helmholtz Association and the Charité-Universitätsmedizin Berlin, Berlin, Germany.
Background:
This study relates to emerging concepts of appropriate trial designs to evaluate effects of intervention on the accumulation of irreversible disability in multiple sclerosis (MS). Major starting points of our study are the known limitations of current definitions of disability progression by rater-based clinical assessment and the high relevance of gait and balance dysfunctions in MS. The study aims to explore a novel definition of disease progression using repeated instrumental assessment of relevant motor functions performed by patients in their home setting.
Methods:
The study is a prospective single-center observational cohort study with the primary outcome acquired by participants themselves, a home-based assessment of motor functions based on an RGB-Depth (RGB-D) camera, a camera that provides both depth (D) and color (RGB) data. Participants are instructed to perform and record a set of simple motor tasks twice a day over a one-week period every 6 months. Assessments are complemented by a set of questionnaires. Annual research grade assessments are acquired at dedicated study visits and include clinical ratings as well as structural imaging (MRI and optical coherence tomography). In addition, clinical data from routine visits is provided semiannually by treating neurologists. The observation period is 24 months for the primary endpoint with an additional clinical assessment at 27 month to confirm progression defined by the Expanded Disability Status Scale (EDSS). Secondary analyses aim to explore the time course of changes in motor parameters and performance of the novel definition against different alternative definitions of progression in MS. The study was registered at Deutsches Register für Klinische Studien (DRKS00027042).
Discussion:
The study design presented here investigates disease progression defined by marker-less home-based assessment of motor functions against 3-month confirmed disease progression (3 m-CDP) defined by the EDSS. The technical approach was chosen due to previous experience in lab-based settings. The observation time per participant of 24, respectively, 27 months is commonly conceived as the lower limit needed to study disability progression. Defining a valid digital motor outcome for disease progression in MS may help to reduce observation times in clinical trials and add confidence to the detection of progression events in MS.
Insights
This study introduces a new way to measure multiple sclerosis (MS) disability progression using home-based motor assessments. This digital approach may shorten clinical trials and improve detection of MS progression.
Area of Science:
- Neurology
- Biomedical Engineering
- Clinical Trial Design
Background:
- Current multiple sclerosis (MS) disability progression assessments have limitations.
- Gait and balance impairments are highly relevant in MS.
- Novel trial designs are needed to evaluate interventions effectively.
Purpose of the Study:
- To explore a novel definition of MS disease progression.
- To utilize repeated, instrumental, home-based motor function assessments.
- To overcome limitations of traditional rater-based clinical assessments.
Main Methods:
- Prospective, single-center observational cohort study.
- Home-based motor function assessment using RGB-Depth cameras.
- Twice-daily recording of motor tasks over 24 months, supplemented by questionnaires and clinical visits.
Main Results:
- The study design compares home-based digital motor outcomes with traditional Expanded Disability Status Scale (EDSS) progression.
- Exploration of motor parameter changes and novel definition performance against alternative progression definitions.
- Data collection includes clinical ratings, imaging (MRI, OCT), and neurologist-provided clinical data.
Conclusions:
- A valid digital motor outcome for MS progression could reduce clinical trial observation times.
- Home-based assessments offer a patient-centric approach to monitoring MS.
- This method may increase confidence in detecting progression events in MS.
