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Clinical Trials/NCT06229691
NCT06229691
Completed
Not Applicable

Muscle Fatigability and Trip-specific Fall Risk in Adults With Knee Osteoarthritis

University of Delaware1 site in 1 country24 target enrollmentMay 14, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis, Knee
Sponsor
University of Delaware
Enrollment
24
Locations
1
Primary Endpoint
Minimum toe clearance during walking
Status
Completed
Last Updated
7 months ago

Overview

Brief Summary

The goal of this clinical trial is to learn about how fatigue affects the risk of falling in adults aged 55-70 years with and without knee osteoarthritis. The main questions this trial aims to answer are:

  • Does fatigue increase the risk of tripping while walking? and

  • Does fatigue increase the risk of falling in response to a trip while walking? Participants will

  • Complete questionnaires

  • Wear a device that measures physical activity for 5-7 days

  • Complete a 30 minute walk on a treadmill

  • Complete the following before and after the treadmill walk:

    • Computer test to measure mental fatigue
    • Maximal strength testing
    • Balance test

Researchers will compare adults with and without knee osteoarthritis to see if fall risk in adults with knee osteoarthritis is affected more by walking activity compared to adults without knee osteoarthritis.

Registry
clinicaltrials.gov
Start Date
May 14, 2024
End Date
August 27, 2025
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • For adults with knee osteoarthritis:
  • presence of occasional to frequent knee pain
  • knee pain that is primarily in the medial knee joint compartment
  • minimal morning joint stiffness
  • For all participants:
  • able to walk continuously for 30 minutes without an assistive device

Exclusion Criteria

  • fracture or surgery within 1 year
  • history of joint replacement
  • lower-extremity joint injections within 3 months
  • history of stroke or other neurological condition
  • cardiovascular or pulmonary conditions that limit daily activity or that preclude participation in exercise
  • history of major lower extremity or back injury or pain (except for knee osteoarthritis)
  • history of lower extremity amputation
  • use an orthotic or prosthetic to walk
  • use of beta blockers or other medications that affect fatigue
  • use of medications that affect balance

Outcomes

Primary Outcomes

Minimum toe clearance during walking

Time Frame: Beginning and end of 30 minute treadmill walk

Minimum toe clearance will be calculated from the first and last minutes of the treadmill walk using optical motion capture.

Anterior reactive stepping

Time Frame: Beginning and end of 30 minute treadmill walk

Stability margins will be calculated from a lean-release test conducted before and after the 30 minute treadmill walk

Anterior stability margins during walking

Time Frame: Beginning and end of 30 minute treadmill walk

Anterior stability margins will be calculated from the first and last minutes of the treadmill walk using optical motion capture.

Knee extensor fatigability

Time Frame: Before and after the 30 minute treadmill walk

Knee extensor fatigability will be calculated as the change in maximum knee extensor power (measured via dynamometry) pre- to post-30 minute treadmill walk

Study Sites (1)

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