Postural StabilityTEPStabilNCT03860610
TEPStabil - Muscle Function and Dynamic and Postural Stability in Patients Receiving Hip or Knee Arthroplasty
An observational study of Postural Stability, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postural Stability
- What is being tested?
- Muscle strength test, Dynamic stability test during level and uphill walking and Postural stability test
- How many people
- 130 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Dec 2018to 7 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Orthopaedics and Traumatology, University Hospital Basel
Basel, 4031
About this study
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.
Read the detailed description
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.
- Conditions
- Postural Stability
- Being tested
- Muscle strength test, Dynamic stability test during level and uphill walking, Postural stability test, EuroQol Group Health questionnaire (EQ-5D-5L), HOOS/ KOOS
- Keywords
- Total Hip Arthroplasty, Total Knee Arthroplasty, Osteoarthritis, Muscle strength deficits, Dynamic stability
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle strength testDiagnostic 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)
Dynamic stability test during level and uphill walkingDiagnostic test
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)
Postural stability testDiagnostic 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.
EuroQol Group Health questionnaire (EQ-5D-5L)Diagnostic test
Overall health will be assessed using the EQ-5D-5L health questionnaire
HOOS/ KOOSDiagnostic test
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).
Muscle activity testDiagnostic 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.
Passive range of motionDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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' Receives: Diagnostic Test: Muscle strength test; Diagnostic Test: Dynamic stability test during level and uphill walking; Diagnostic Test: Postural stability test; Diagnostic Test: EuroQol Group Health questionnaire (EQ-5D-5L); Diagnostic Test: HOOS/ KOOS; Diagnostic Test: Muscle activity test; Diagnostic Test: Passive range of motion | |
| 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' Receives: Diagnostic Test: Muscle strength test; Diagnostic Test: Dynamic stability test during level and uphill walking; Diagnostic Test: Postural stability test; Diagnostic Test: EuroQol Group Health questionnaire (EQ-5D-5L); Diagnostic Test: HOOS/ KOOS; Diagnostic Test: Muscle activity test; Diagnostic Test: Passive range of motion | |
| 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' Receives: Diagnostic Test: Muscle strength test; Diagnostic Test: Dynamic stability test during level and uphill walking; Diagnostic Test: Postural stability test; Diagnostic Test: EuroQol Group Health questionnaire (EQ-5D-5L); Diagnostic Test: HOOS/ KOOS; Diagnostic Test: Muscle activity test; Diagnostic Test: Passive range of motion | |
| 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' Receives: Diagnostic Test: Muscle strength test; Diagnostic Test: Dynamic stability test during level and uphill walking; Diagnostic Test: Postural stability test; Diagnostic Test: EuroQol Group Health questionnaire (EQ-5D-5L); Diagnostic Test: HOOS/ KOOS; Diagnostic Test: Muscle activity test; Diagnostic Test: Passive range of motion | |
| 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' Receives: Diagnostic Test: Muscle strength test; Diagnostic Test: Dynamic stability test during level and uphill walking; Diagnostic Test: Postural stability test; Diagnostic Test: EuroQol Group Health questionnaire (EQ-5D-5L); Diagnostic Test: HOOS/ KOOS; Diagnostic Test: Muscle activity test; Diagnostic Test: Passive range of motion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength (Study 1)
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)
Measured: single point measurement at Visit A (week 0)
Change in Muscle strength (Study 2)
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)
Measured: Three assessments will be performed: preoperatively (visit 1), 6 weeks postoperatively (visit 2) and 1 year postoperative (visit 3).
Postural stability (Study 1)
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)
Measured: single point measurement at Visit A (week 0)
Change in postural stability (Study 2)
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)
Measured: Three assessments will be performed: preoperatively (visit 1), 6 weeks postoperatively (visit 2) and 1 year postoperative (visit 3).
Dynamic stability (Study 1)
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)
Measured: single point measurement at Visit A (week 0)
Change in dynamic stability (Study 2)
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)
Measured: Three assessments will be performed: preoperatively (visit 1), 6 weeks postoperatively (visit 2) and 1 year postoperative (visit 3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start10 Dec 2018
- Primary completion7 Dec 2021
- Study completion7 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural StabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annegret Muendermann, Prof. Dr. MD, Principal investigator, Department of Orthopaedics and Traumatology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860610
- Sponsor's protocol ID
- 2018-02159; ch19Muendermann
- Other IDs
- 2018
- Acronym
- TEPStabil
- Status last verified
- Mar 2022
- First submitted
- 26 Feb 2019
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TEPStabil - Muscle Function and Dynamic and Postural Stability in Patients Receiving Hip or Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03860610
- Acronym / sponsor ID
- TEPStabil / 2018-02159; ch19Muendermann
- Conditions
- Postural Stability
- Keywords
- Total Hip Arthroplasty, Total Knee Arthroplasty, Osteoarthritis, Muscle strength deficits, Dynamic stability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 7 Dec 2021 (actual)
- Study completion
- 7 Dec 2021 (actual)
- First posted
- 4 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Patient group 1 after THA | – | Diagnostic Test: Muscle strength test, Diagnostic Test: Dynamic stability test during level and uphill walking, Diagnostic Test: Postural stability test, Diagnostic Test: EuroQol Group Health questionnaire (EQ-5D-5L), Diagnostic Test: HOOS/ KOOS, Diagnostic Test: Muscle activity test, Diagnostic Test: Passive range of motionPatients 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' |
| Patient group 2 after TKA | – | Diagnostic Test: Muscle strength test, Diagnostic Test: Dynamic stability test during level and uphill walking, Diagnostic Test: Postural stability test, Diagnostic Test: EuroQol Group Health questionnaire (EQ-5D-5L), Diagnostic Test: HOOS/ KOOS, Diagnostic Test: Muscle activity test, Diagnostic Test: Passive range of motionPatients 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' |
| Patient group 3 before THA | – | Diagnostic Test: Muscle strength test, Diagnostic Test: Dynamic stability test during level and uphill walking, Diagnostic Test: Postural stability test, Diagnostic Test: EuroQol Group Health questionnaire (EQ-5D-5L), Diagnostic Test: HOOS/ KOOS, Diagnostic Test: Muscle activity test, Diagnostic Test: Passive range of motionPatients 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' |
| Patient group 4 before TKA | – | Diagnostic Test: Muscle strength test, Diagnostic Test: Dynamic stability test during level and uphill walking, Diagnostic Test: Postural stability test, Diagnostic Test: EuroQol Group Health questionnaire (EQ-5D-5L), Diagnostic Test: HOOS/ KOOS, Diagnostic Test: Muscle activity test, Diagnostic Test: Passive range of motionPatients 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' |
| Healthy control group | – | Diagnostic Test: Muscle strength test, Diagnostic Test: Dynamic stability test during level and uphill walking, Diagnostic Test: Postural stability test, Diagnostic Test: EuroQol Group Health questionnaire (EQ-5D-5L), Diagnostic Test: HOOS/ KOOS, Diagnostic Test: Muscle activity test, Diagnostic Test: Passive range of motionAge-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' |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle strength testMuscle 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 | Healthy control group, Patient group 1 after THA, Patient group 2 after TKA, Patient group 3 before THA, Patient group 4 before TKA |
| Dynamic stability test during level and uphill walkingInstrumented 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 | Healthy control group, Patient group 1 after THA, Patient group 2 after TKA, Patient group 3 before THA, Patient group 4 before TKA |
| Postural stability testThe 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 | Healthy control group, Patient group 1 after THA, Patient group 2 after TKA, Patient group 3 before THA, Patient group 4 before TKA |
| EuroQol Group Health questionnaire (EQ-5D-5L)Overall health will be assessed using the EQ-5D-5L health questionnaire | Diagnostic test | Healthy control group, Patient group 1 after THA, Patient group 2 after TKA, Patient group 3 before THA, Patient group 4 before TKA |
| HOOS/ KOOSSite 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 | Healthy control group, Patient group 1 after THA, Patient group 2 after TKA, Patient group 3 before THA, Patient group 4 before TKA |
| Muscle activity testSurface 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 | Healthy control group, Patient group 1 after THA, Patient group 2 after TKA, Patient group 3 before THA, Patient group 4 before TKA |
| Passive range of motionPassive 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. | Diagnostic test | Healthy control group, Patient group 1 after THA, Patient group 2 after TKA, Patient group 3 before THA, Patient group 4 before TKA |
Primary outcome
Muscle strength (Study 1)
Time frame: 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)
Change in Muscle strength (Study 2)
Time frame: 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)
Postural stability (Study 1)
Time frame: 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)
Change in postural stability (Study 2)
Time frame: 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)
Dynamic stability (Study 1)
Time frame: 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)
Change in dynamic stability (Study 2)
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annegret Muendermann, Prof. Dr. MD principal investigator
Department of Orthopaedics and Traumatology, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postural Stability, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle strength (Study 1) (time frame: single point measurement at Visit A (week 0)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2022.