Clinical trial NCT03750097: Validation of a Smartwatch in Persons With Multiple Sclerosis
Official title: Validation of a Commercially Available Smartwatch for Step Detection in Persons With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Motion sensors
Smartwatch
Steps
Walking
Validation
Lead sponsor: University of Erlangen-Nürnberg
Sponsor class: OTHER
Collaborators: name: Neurological Rehabilitation Center Quellenhof
name: ZTM Bad Kissingen
First posted: 2018-11-21
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study is designed to validate the accuracy of steps detected by a commercially available smartwatch in persons with multiple sclerosis. Specifically, the investigators examine whether a smartwatch can detect steps accurately during slow, comfortable and fast overground walking. The total steps counted by the smartwatch will be compared to those counted by an accelerometer commonly used in clinical studies and the actually walked steps.

Detailed description: Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system. It is one of the most common neurological diseases in young adulthood. The main symptoms of MS are gait and mobility impairments, which also determine the severity of the disease. Currently, subjective clinical functional tests are commonly used to evaluate therapy outcomes. Due to advancing mechanization, body-worn accelerometers have been established as a potential instrument for the objective detection of mobility in clinical research. The accuracy of these devices for determining the mobility is therefore essential. However, current studies, especially in people with altered gait, show large deviations in step detection accuracy.

In the present study we want to investigate: i) whether a commercially available smartwatch (Polar M600) counts steps in persons with multiple sclerosis (pwMS) accurately and ii) whether it counts steps as accurately as an accelerometer commonly used in clinical research (ActiGraph wGT3X-BT). In addition, the accuracy of the step detection by the algorithms of the manufacturer of the two devices (Polar M600 and ActiGraph wGT3X-BT) will be compared with an own-developed algorithm.

For this purpose, 63 pwMS with low to severe functional restriction (EDSS: 0 - 6.5) will participate in this validation study. The validation protocol consists of three walking tests with different walking velocities. During these three conditions the participants will wear the Polar M600 on the wrist and the ActiGraph wGT3X-BT with a belt over the hip. In the first walking test, the subjects will complete 250 steps with comfortable walking velocity (CWV). After a sufficient break, the participants will be randomly assigned to either a fast walking velocity condition (FWV: CWV + 20%) followed by a sufficient period of rest and a slow walking velocity condition (SWV: CWV - 20%) or vice versa. Each of the walking tests with modified walking velocity also consists of 250 steps. To analyze the accuracy of step detection, the measured steps of the devices will be compared with the actually walked 250 steps.

Eligibility criteria: Inclusion Criteria:

* Multiple Sclerosis with Expanded Disability Status Scale between 0 - 6.5
* Ability to walk 250 steps with or without an assistive device

Exclusion Criteria:

* Clinically relevant cardiovascular or orthopaedic disease
* Severe polyneuropathy
* Cognitive impairment

Primary outcomes:
measure: Step detection during comfortable walking
timeFrame: Following the comfortable walking velocity protocol, an average of 2 minutes
Secondary outcomes:
measure: Step detection during slow walking
timeFrame: Following the slow walking velocity protocol, an average of 2 minutes
measure: Step detection during fast walking
timeFrame: Following the fast walking velocity protocol, an average of 2 minutes
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Department of Sport Science and Sport, Gebbertstr. 123b
Study officials:
affiliation: Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Department of Sport Science and Sport
name: Klaus Pfeifer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Neurological Rehabilitation Center Quellenhof
name: Peter Flachenecker, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: