Last updated: 10/18/2023 17:10:38

A device feasibility study for use of StepWatch™, a wearable sensor for adult participants with knee osteoarthritis

GSK study ID
214427
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Device Feasibility and Analytical Validation Study of the Use of StepWatch™, a Wearable Sensor to Measure Physical Function in Adult Participants aged 40-75 with Knee Osteoarthritis
Trial description: This is a prospective, unblinded, device feasibility and analytical validation study with moderate, symptomatic knee osteoarthritis (OA) participants. Participants will participate in a 1-day analytical device validation phase in-clinic, and will then be followed prospectively for 14 days in their free-living home environment while using the device. In this study, there are no interventions other than the wearing of the StepWatch™.
Primary purpose:
Diagnostic
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Average hours of device recording per day

Timeframe: Up to 14 days

Barriers and facilitators of StepWatch™ use among participants described via a structured feasibility questionnaire and ad-hoc usage diary

Timeframe: Up to 14 days

Incidence of technical issues encountered, specifically measured by incidence of need for support or intervention from device vendor

Timeframe: Up to 14 days

The percentage of data unusable due to reasons other than participant non-compliance

Timeframe: Up to 14 days

Barriers and facilitators of StepWatch™ deployment by clinical sites, described via a questionnaire delivered to site personnel

Timeframe: Up to 14 days

Secondary outcomes:

Accuracy of device-derived step count and cadence (steps/time), compared to video-monitoring

Timeframe: On Day 1

Accuracy of device-derived walking velocity, compared with timed in-clinic walking tests

Timeframe: On Day 1

Self-reported incidence of device related Adverse Events (AEs)

Timeframe: Up to 14 days

Interventions:
  • Device: StepWatch TM
    • Enrollment:
    25
    Primary completion date:
    2022-19-10
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Osteoarthritis
    Product
    GSK3858279
    Collaborators
    Not applicable
    Study date(s)
    June 2022 to October 2022
    Type
    Interventional
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    40 - 75 Years
    Accepts healthy volunteers
    No
    • Participant must be 40-75 years of age inclusive, at the time of signing the informed consent
    • Participants who are meet American College of Rheumatology (ACR) criteria for knee osteoarthritis based on clinical and radiographic criteria:
    • Participants are excluded from the study if any of the following criteria apply:
    • Rheumatoid arthritis
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Participant must be 40-75 years of age inclusive, at the time of signing the informed consent

      • Participants who are meet American College of Rheumatology (ACR) criteria for knee osteoarthritis based on clinical and radiographic criteria: i. Knee pain ii. Osteophytes visible on Anterior Posterior (AP) radiograph of the knee iii. At least one of the following three:

      • Age at least 50
      • Morning stiffness lasting less than 30 minutes
      • Crepitus
    • Kellgren-Lawrence (KL) grade 2-4 knee osteoarthritis based on AP x-ray of the knee or Magnetic resonance imaging (MRI) of the knee within 24 months of study enrolment
    • Worst pain in the past 24 hours at least 4/10
    • Knee pain present for at least 3 months at the time of screening
    • There are no restrictions based on body weight or Body Mass Index (BMI)
    • Male or female
    • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
    • Willing to wear StepWatch™ device daily for 14 days and comply with other study activities
    Exclusion criteria:

      Participants are excluded from the study if any of the following criteria apply:

      • Rheumatoid arthritis
      • Gout involving the knee
      • Joint replacement in both knees
      • Unable to walk without assistance
      • Neurologic condition affecting gait in the opinion of the investigator, including Parkinson’s disease and stroke.
      • A history of severe skin hypersensitivity

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Protocol
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2022-19-10
    Actual study completion date
    2022-19-10

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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