Validation of a Smartwatch in Persons With Multiple Sclerosis

Validation of a Commercially Available Smartwatch for Step Detection in Persons With Multiple Sclerosis

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Comfortable walking velocity (CWV); Behavioral: Slow walking velocity (SWV: CWV - 20%); Behavioral: Fast walking velocity (FWV: CWV + 20%)

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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Erlangen, Germany, 91058
    • Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Department of Sport Science and Sport, Gebbertstr. 123b

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Walking protocol; Walking for 250 steps with comfortable walking velocity (CWV), slow walking velocity (SWV: CWV - 20%) and fast walking velocity (FWV: CWV + 20%) with sufficient rest between conditions.

Behavioral: Comfortable walking velocity (CWV); Walking for 250 Steps with self-selected comfortable walking velocity while wearing the two accelerometers (Polar M600 and ActiGraph wGT3X-BT); Behavioral: Slow walking velocity (SWV: CWV - 20%); Walking for 250 Steps with slow walking velocity while wearing the two accelerometers (Polar M600 and ActiGraph wGT3X-BT). Slow walking consists of walking with 20% slower than the self-selected comfortable walking velocity by following a researcher who controls the walking velocity with a measuring wheel.; Behavioral: Fast walking velocity (FWV: CWV + 20%); Walking for 250 Steps with fast walking velocity while wearing the two accelerometers (Polar M600 and ActiGraph wGT3X-BT). Fast walking consists of walking with 20% faster than the self-selected comfortable walking velocity by following a researcher who controls the walking velocity with a measuring wheel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Step detection during comfortable walking	Step detection accuracy of the two devices (Polar M600 and ActiGraph wGT3X-BT) for both the standard algorithm and the self-developed algorithm during comfortable walking for 250 steps.	Following the comfortable walking velocity protocol, an average of 2 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Step detection during slow walking	Step detection accuracy of the two devices (Polar M600 and ActiGraph wGT3X-BT) for both the standard algorithm and the self-developed algorithm during slow walking for 250 steps.	Following the slow walking velocity protocol, an average of 2 minutes
Step detection during fast walking	Step detection accuracy of the two devices (Polar M600 and ActiGraph wGT3X-BT) for both the standard algorithm and the self-developed algorithm during fast walking for 250 steps.	Following the fast walking velocity protocol, an average of 2 minutes

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg
• Collaborators: Neurological Rehabilitation Center Quellenhof; ZTM Bad Kissingen
• Investigators: Principal Investigator: Klaus Pfeifer, Prof. Dr., Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Department of Sport Science and Sport

Publications and helpful links

Helpful Links

• Project webpage

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): December 15, 2018
• Study Completion (Actual): January 31, 2019

Study Registration Dates

• First Submitted: July 30, 2018
• First Submitted That Met QC Criteria: November 20, 2018
• First Posted (Actual): November 21, 2018

Study Record Updates

• Last Update Posted (Actual): April 12, 2019
• Last Update Submitted That Met QC Criteria: April 11, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Validation; Walking; Smartwatch; Steps; Motion sensors
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: ms-bewegt-Validation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No