NCT03750097

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 21, 2018

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

April 12, 2019

Status Verified

April 1, 2019

Enrollment Period

8 months

First QC Date

July 30, 2018

Last Update Submit

April 11, 2019

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisMotion sensorsSmartwatchStepsWalkingValidation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Step detection during slow walking

    Following the slow walking velocity protocol, an average of 2 minutes

  • Step detection during fast walking

    Following the fast walking velocity protocol, an average of 2 minutes

Study Arms (1)

Walking protocol

EXPERIMENTAL

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)Behavioral: Slow walking velocity (SWV: CWV - 20%)Behavioral: Fast walking velocity (FWV: CWV + 20%)

Interventions

Comfortable walking velocity (CWV)BEHAVIORAL

Walking for 250 Steps with self-selected comfortable walking velocity while wearing the two accelerometers (Polar M600 and ActiGraph wGT3X-BT)

Walking protocol
Slow walking velocity (SWV: CWV - 20%)BEHAVIORAL

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.

Walking protocol
Fast walking velocity (FWV: CWV + 20%)BEHAVIORAL

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.

Walking protocol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Erlangen, 91058, Germany

Location

Related Links

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Klaus Pfeifer, Prof. Dr.

    Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Department of Sport Science and Sport

    PRINCIPAL INVESTIGATOR

  • Peter Flachenecker, Prof. Dr. med.

    Neurological Rehabilitation Center Quellenhof

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

July 30, 2018

First Posted

November 21, 2018

Study Start

May 1, 2018

Primary Completion

December 15, 2018

Study Completion

January 31, 2019

Last Updated

April 12, 2019

Record last verified: 2019-04

Locations

DE(1)