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TEPStabil - Muscle Function and Dynamic and Postural Stability in Patients Receiving Hip or Knee Arthroplasty (TEPStabil)

2022년 3월 3일 업데이트: University Hospital, Basel, Switzerland

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.

연구 개요

상세 설명

Postural stability is defined as the ability to maintain the body's centre of gravity within the limits of stability as determined by the base of support. It is further divided in static and dynamic stability involving the ability of maintaining a base of support while standing or completing a functional Task. The importance of postural stability is accepted as a factor predicting falls and affecting the ability to perform activities of daily living.

Despite of reported strength deficits and the importance of balance, to date the potential contribution of strength deficits in patients before and after Total Hip Arthroplasty (THA) or Total Knee Arthroplasty (TKA) to compromised balance ability is unknown. Furthermore, the role of preoperative muscle function on functional outcome of THA and TKA is poorly understood. A correlation between compromised preoperative muscular function and postoperative outcome would suggest that preoperative physical therapy may be critical for preserving the muscular status and may help explain reported poorer outcome after late treatment when muscular function has already deteriorated.

The project includes two studies differing in design and primary and secondary objectives but with overlapping patient populations.

Study 1 will include all five groups, and there is only one visit by the participant (visit A).

Study 2 will include only patients from groups 3 and 4. Three assessments will be performed: preoperatively (visit 1), 6 weeks postoperatively (visit 2) and 1 year postoperative (visit 3). Visit 1 will be identical to visit A in study 1 in these two patient groups.

연구 유형

관찰

등록 (실제)

130

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Basel, 스위스, 4031
        • Department of Orthopaedics and Traumatology, University Hospital Basel

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

30년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

샘플링 방법

확률 샘플

연구 인구

Participants will be recruited by consecutive recruitment through the contributing surgeons in daily clinical practice, referring physicians and advertisements placed bi-monthly in the University of Basel "Uni-news" and ongoing on the department website. Healthy participants will be recruited by advertisements placed bi-monthly in the University of Basel "Uni-news", local health and sports clubs and ongoing on the department website.

설명

Inclusion Criteria:

  • Patients with an unilateral THA or TKA, which they received for the treatment of osteoarthritis (Patient groups 1+2)
  • Patients diagnosed with unilateral OA of the knee or hip planned for a treatment with THA or TKA (Patient groups 3+4)
  • Age ≥ 30 years (Healthy control group)

Exclusion Criteria:

  • Body mass index > 35kg/m2
  • Use of walking aids
  • Neuromuscular disorders affecting gait
  • Inability to follow procedures due to psychological disorders or dementia
  • Diagnosed hip or knee OA (Healthy control group)
  • Current pain in the lower extremities or lower back (Healthy control group)
  • Rheumatoid Arthritis (Healthy control group)
  • Previous corrective osteotomy (Healthy control group)
  • Regular intake of pain medication (more than 4 times per week) (Healthy control group)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
Patient group 1 after THA
Patients who have already received a THA (N=30) for OA will be assessed 1 year postoperatively (Visit A); Interventions in this Group: 'Muscle strength test', 'Dynamic stability test during level and uphill walking', 'Postural stability test', 'EuroQol Group Health questionnaire (EQ-5D-5L)', 'HOOS/ KOOS', ' Muscle activity test', 'Passive range of motion'
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)
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)
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.
Overall health will be assessed using the EQ-5D-5L health questionnaire
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).
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.
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.
Patient group 2 after TKA
Patients who have already received a TKA (N=30) for OA will be assessed 1 year postoperatively (Visit A); Interventions in this Group: 'Muscle strength test', 'Dynamic stability test during level and uphill walking', 'Postural stability test', 'EuroQol Group Health questionnaire (EQ-5D-5L)', 'HOOS/ KOOS', ' Muscle activity test', 'Passive range of motion'
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)
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)
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.
Overall health will be assessed using the EQ-5D-5L health questionnaire
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).
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.
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.
Patient group 3 before THA
Patients with severe hip OA (N=30) scheduled to receive a THA will be assessed preoperatively (Visit 1), 12 weeks postoperative (Visit 2) and 1 year postoperative (Visit 3). Interventions in this Group: 'Muscle strength test', 'Dynamic stability test during level and uphill walking', 'Postural stability test', 'EuroQol Group Health questionnaire (EQ-5D-5L)', 'HOOS/ KOOS', ' Muscle activity test', 'Passive range of motion'
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)
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)
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.
Overall health will be assessed using the EQ-5D-5L health questionnaire
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).
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.
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.
Patient group 4 before TKA
Patients with severe knee OA (N=30) scheduled to receive a TKA will be assessed preoperatively (Visit 1), 12 weeks postoperative (Visit 2) and 1 year postoperative (Visit 3). Interventions in this Group: 'Muscle strength test', 'Dynamic stability test during level and uphill walking', 'Postural stability test', 'EuroQol Group Health questionnaire (EQ-5D-5L)', 'HOOS/ KOOS', ' Muscle activity test', 'Passive range of motion'
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)
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)
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.
Overall health will be assessed using the EQ-5D-5L health questionnaire
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).
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.
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.
Healthy control group
Age-matched healthy control subjects (N=30);Interventions in this Group: 'Muscle strength test', 'Dynamic stability test during level and uphill walking', 'Postural stability test', 'EuroQol Group Health questionnaire (EQ-5D-5L)', 'HOOS/ KOOS', ' Muscle activity test', 'Passive range of motion'
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)
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)
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.
Overall health will be assessed using the EQ-5D-5L health questionnaire
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).
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.
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Muscle strength (Study 1)
기간: single point measurement at Visit A (week 0)
For the knee, maximum isokinetic flexion and extension torques will be collected between full extension and 90° flexion at a movement speed of 60°/s (5 repetitions) and 240°/s (5 repetitions).For the hip, maximum abduction torques will be measured isometrically (5 repetitions) in a standing position. Maximum joint torques in each movement direction will be recorded for each joint and normalized to body weight (study group 1 to 5)
single point measurement at Visit A (week 0)
Change in Muscle strength (Study 2)
기간: Three assessments will be performed: preoperatively (visit 1), 6 weeks postoperatively (visit 2) and 1 year postoperative (visit 3).
For the knee, maximum isokinetic flexion and extension torques will be collected between full extension and 90° flexion at a movement speed of 60°/s (5 repetitions) and 240°/s (5 repetitions).For the hip, maximum abduction torques will be measured isometrically (5 repetitions) in a standing position. Maximum joint torques in each movement direction will be recorded for each joint and normalized to body weight (study group 3 and 4)
Three assessments will be performed: preoperatively (visit 1), 6 weeks postoperatively (visit 2) and 1 year postoperative (visit 3).
Postural stability (Study 1)
기간: single point measurement at Visit A (week 0)
The overall stability index (OSI) will be assessed using the Biodex Balance System SD. A high stability index represents the angular excursion of the subject's center of gravity and is indicative of a high degree of movement during a test (i.e.poor balance). (study group 1 to 5)
single point measurement at Visit A (week 0)
Change in postural stability (Study 2)
기간: Three assessments will be performed: preoperatively (visit 1), 6 weeks postoperatively (visit 2) and 1 year postoperative (visit 3).
The overall stability index (OSI) will be assessed using the Biodex Balance System SD. A high stability index represents the angular excursion of the subject's center of gravity and is indicative of a high degree of movement during a test (i.e.poor balance).(study group 3 and 4)
Three assessments will be performed: preoperatively (visit 1), 6 weeks postoperatively (visit 2) and 1 year postoperative (visit 3).
Dynamic stability (Study 1)
기간: single point measurement at Visit A (week 0)
Instrumented gait analysis on an overground walkway to compute step width for each step from a pressure plate built into the treadmill (study group 1 to 5)
single point measurement at Visit A (week 0)
Change in dynamic stability (Study 2)
기간: Three assessments will be performed: preoperatively (visit 1), 6 weeks postoperatively (visit 2) and 1 year postoperative (visit 3).
Instrumented gait analysis on an overground walkway to compute step width for each step from a pressure plate built into the treadmill (study group 3 and 4)
Three assessments will be performed: preoperatively (visit 1), 6 weeks postoperatively (visit 2) and 1 year postoperative (visit 3).

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Annegret Muendermann, Prof. Dr. MD, Department of Orthopaedics and Traumatology, University Hospital Basel

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2018년 12월 10일

기본 완료 (실제)

2021년 12월 7일

연구 완료 (실제)

2021년 12월 7일

연구 등록 날짜

최초 제출

2019년 2월 26일

QC 기준을 충족하는 최초 제출

2019년 2월 26일

처음 게시됨 (실제)

2019년 3월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 3월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2022년 3월 3일

마지막으로 확인됨

2022년 3월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 2018-02159; ch19Muendermann

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Muscle strength test에 대한 임상 시험

3
구독하다