TEPStabil - Muscle Function and Dynamic and Postural Stability in Patients Receiving Hip or Knee Arthroplasty
NCT03860610 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 130
Last updated 2022-03-04
Summary
Study 1 is to determine if muscle strength and dynamic and postural stability are compromised in patients with severe hip or knee Osteoarthritis (OA) and in patients after THA and TKA.
Study 2 is to quantify the effect of THA and TKA on muscle strength and dynamic and postural stability.
Conditions
- Postural Stability
Interventions
- DIAGNOSTIC_TEST
-
Muscle strength test
Muscle strength in knee flexion and extension and hip abduction will be tested using using a dynamometer (Biodex System 4 Pro: Biodex Medical Systems, Shirley, NY, USA)
- DIAGNOSTIC_TEST
-
Dynamic stability test during level and uphill walking
Instrumented gait analysis on an overground walkway with two embedded force plates (Kistler force plate 9260AA6, Kistler AG, Winterthur, Switzerland; sampling rate 2400 Hz) and on a treadmill with an embedded plantar pressure plate (h/p/cosmos, Zebris FDM-T, Isny, Germany)
- DIAGNOSTIC_TEST
-
Postural stability test
The overall stability index (OSI) will be assessed using the Biodex Balance System SD (Biodex Medical Systems, Inc., Shirley, NY, USA) and is determined by the variance in platform displacement from the horizontal plane.
- DIAGNOSTIC_TEST
-
EuroQol Group Health questionnaire (EQ-5D-5L)
Overall health will be assessed using the EQ-5D-5L health questionnaire
- DIAGNOSTIC_TEST
-
HOOS/ KOOS
Site specific pain and function will be assessed with the Hip Osteoarthritis Outcome Score (HOOS) and Knee Injury and Osteoarthritis Outcome Score (KOOS) depending on the affected joint (hip or knee).
- DIAGNOSTIC_TEST
-
Muscle activity test
Surface electrodes (Ag/AgCl, Noraxon, U.S.A. Inc., Scottsdale, AZ, USA: 10 mm diameter, 22 mm inter-electrode distance) will be placed bilaterally on glutaeus medius, vastus medialis, semitendinosus, tibialis anterior, gastrocnemius medialis, and peroneus longus muscles. Periods of muscle activity will be defined as intensity above 2 Standard Deviation (SD) of the resting Electromyography (EMG) signal. Duration of overlapping muscle activity between agonists and antagonists normalized to one gait cycle or of a balance test, respectively, will be determined.
- DIAGNOSTIC_TEST
-
Passive range of motion
Passive range of motion will be assessed for ankle plantar-/dorsiflexion, knee flexion/extension and hip flexion/extension, ab/adduction, internal/external rotation using goniometers and recorded in degrees. The range between two maxima will be recorded.
Sponsors & Collaborators
-
University Hospital, Basel, Switzerland
lead OTHER
Principal Investigators
-
Annegret Muendermann, Prof. Dr. MD · Department of Orthopaedics and Traumatology, University Hospital Basel
Eligibility
- Min Age
- 30 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-12-10
- Primary Completion
- 2021-12-07
- Completion
- 2021-12-07
Countries
- Switzerland
Study Locations
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