- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03326531
"Gait and Balance in Patients With SCFE"
Slipped Capital Femoral Epiphysis; Changes in Gait, Balance and Muscle Activity Patterns in Patients Treated With Single Screw in Situ Fixation Investigated Using Computer Assisted Rehabilitation ENvironment (CAREN)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Rationale: Slipped Capital Femoral Epiphysis (SCFE) treated with one screw in situ fixation results in an altered gait. It is thought that the protraction of the pelvis at the affected side, seen in patients with unilateral stable SCFE, is a compensatory mechanism to reduce out-toeing and thereby improve foot positioning to restores the gait patterns towards a 'normal gait pattern. The goal of this study is to investigate this hypothesis since only a few studies are conducted evaluating gait in treated SCFE. It is also thought that this pathology results in an impaired balance. Computer Assisted Rehabilitation Environment (CAREN) will be used.
Objective: The primary objective of this study is to investigate whether protraction of the pelvis at the affected side is a compensatory mechanism to reduce out-toeing and thereby improve foot positioning and restores the gait pattern towards a 'normal' gait pattern in patients with unilateral stable SCFE, treated with single screw in situ fixation. Dynamic postural balance will be analysed as well since an altered, waddling gait, is observed in patients with treated SCFE. In addition, activity patterns of lower limb muscles will also be evaluated using surface electromyography. Kinematic and EMG data of patients will be compared with data of healthy controls with no gait pathology in order to investigate these objectives.
Secondary objectives are the evaluation of clinical outcomes and spatiotemporal parameters in these patients compared to healthy controls.
Study design: a comparative cross-sectional case-control study.
Study population: Children and adolescents with stable SCFE managed with single screw in situ fixation and an age, gender and BMI matched healthy controls without gait pathology. Patients were excluded if major complications occurred due to in situ fixation, if they had revision surgery or had additional pathology leading to gait alterations. In addition, patients are required to walk without walking aid for at least 30 minutes.
Main study parameters/endpoints: Kinematic data will be studied at pelvis, hip, knee and ankle level. Margins of stability will be calculated to analyse dynamic postural balance. In addition, lower extremity muscle activation patterns of SCFE patients will be recorded to assess muscle activation pattern during gait. Correlations between the severity of initial slip and the clinical outcome after treatment will be evaluated.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risk of CAREN based gait analysis is negligible. A safety harness provides protection against falling. It will avoid subject falling on or off the treadmill while performing training. The safety harness is secured with a life line to the ceiling. The burden of the children or adolescents is minimal. Participants will visit the MUMC+ once, where questionnaires (Hip Injury Osteoarthritis Outcome Score, SF-36 questionnaires, Borg CR10 Score and NRS score) physical examination and gait analysis will be performed. The whole session will take 2 hours. Due to the nature of the study, this study can only be done using this specific patient group.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Adhiambo M. Witlox, PhD, MD
- Phone Number: +31433875038
- Email: ma.witlox@mumc.nl
Study Contact Backup
- Name: Jasper Stevens, MD, PhD-candidate
- Phone Number: +31433875038
- Email: jasper.stevens@mumc.nl
Study Locations
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Limburg
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Maastricht, Limburg, Netherlands, 6202AZ
- Recruiting
- Maastricht University Medical Centre
-
Contact:
- Adhiambo M. Witlox, MD, PhD
- Phone Number: 0031433875038
- Email: ma.witlox@mumc.nl
-
Contact:
- Jasper Stevens, MD, PhD-candidate
- Phone Number: 0031433875038
- Email: jasper.stevens@mumc.nl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Aged between 8 and 21 years.
- Unilateral stable SCFE, with clinical and radiological confirmation and lateral slip angles ranging from mild (LSA <30°), moderate (LSA 30°-50°) to severe (LSA >50°) based on the method of Southwick.
- Treatment of the slip with single screw in situ fixation in the last ten years, with no evidence of major complications related to the procedure like chondrolysis, avascular necrosis and infection or slip progression. Follow up at our institution for at least one year.
- Ability to walk 30 minutes without aid.
- Is able to speak, read and write the Dutch language
Exclusion Criteria:
- Clinical or radiological evidence of a contralateral slip or an endocrinopathy as underlying cause of SCFE.
- Revision surgery.
- Other pathology leading to gait alterations.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Joint range of motion
Time Frame: During an entire gait cycle while walking on the CAREN system during the only study visit moment (e.g. 6 months till 10 years after surgery).
|
Range of motion (i.e.
maximal angle minus minimal angle in degrees) of the pelvis, hip, knee and ankle of the affected and unaffected side in degrees.
|
During an entire gait cycle while walking on the CAREN system during the only study visit moment (e.g. 6 months till 10 years after surgery).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Absolute joint angles
Time Frame: During an entire gait cycle while walking on the CAREN system during the only study visit moment (e.g. 6 months till 10 years after surgery).
|
Absolute joint angles of the pelvis, hip, knee and ankle of both the affected and unaffected side in degrees.
|
During an entire gait cycle while walking on the CAREN system during the only study visit moment (e.g. 6 months till 10 years after surgery).
|
Margins of Stability
Time Frame: During an entire gait cycle while walking on the CAREN system during the only study visit moment (e.g. 6 months till 10 years after surgery).
|
Margins of Stability is a measure to describe balance during gait
|
During an entire gait cycle while walking on the CAREN system during the only study visit moment (e.g. 6 months till 10 years after surgery).
|
Muscle activation patterns
Time Frame: During an entire gait cycle while walking on the CAREN system during the only study visit moment (e.g. 6 months till 10 years after surgery).
|
Muscle activation patterns of lower limb muscles will be recorded during gait by using EMG
|
During an entire gait cycle while walking on the CAREN system during the only study visit moment (e.g. 6 months till 10 years after surgery).
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Gait velocity
Time Frame: During an entire gait cycle while walking on the CAREN system during the only study visit moment (e.g. 6 months till 10 years after surgery).
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Gait velocity (in m/sec)
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During an entire gait cycle while walking on the CAREN system during the only study visit moment (e.g. 6 months till 10 years after surgery).
|
Hip Injury and Osteoarthritis Outcome Score
Time Frame: One minute before the start of the test on the CAREN system during the only study visit moment (e.g. 6 months till 10 years after surgery).
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Scoring system to assess general outcome after hip surgery
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One minute before the start of the test on the CAREN system during the only study visit moment (e.g. 6 months till 10 years after surgery).
|
SF-36 questionnaire
Time Frame: One minute before the start of the test on the CAREN system during the only study visit moment (e.g. 6 months till 10 years after surgery).
|
Scoring system to assess quality of life after hip surgery
|
One minute before the start of the test on the CAREN system during the only study visit moment (e.g. 6 months till 10 years after surgery).
|
Borg CR10 scale
Time Frame: One minute before the test on the CAREN system and one minute after the last gait cycle walked on the CAREN system during the only study visit moment (e.g. 6 months till 10 years after surgery).
|
Scoring system to assess the severity of tiredness during the test
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One minute before the test on the CAREN system and one minute after the last gait cycle walked on the CAREN system during the only study visit moment (e.g. 6 months till 10 years after surgery).
|
NRS/VAS score
Time Frame: One minute before the test on the CAREN system and one minute after the last gait cycle walked on the CAREN system during the only study visit moment (e.g. 6 months till 10 years after surgery).
|
Scoring system to assess pain during the test
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One minute before the test on the CAREN system and one minute after the last gait cycle walked on the CAREN system during the only study visit moment (e.g. 6 months till 10 years after surgery).
|
Radiological outcome
Time Frame: Assessed during the only study visit moment (e.g. 6 months till 10 years after surgery).
|
The Southwick Angle is used to assess the severity of initial slip
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Assessed during the only study visit moment (e.g. 6 months till 10 years after surgery).
|
Cadence (in steps/min)
Time Frame: During the entire gait cycle while walking on the CAREN system, during the only study visit moment (e.g. 6 months till 10 years after surgery).
|
Cadance (in steps/min)
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During the entire gait cycle while walking on the CAREN system, during the only study visit moment (e.g. 6 months till 10 years after surgery).
|
Step width (in cm) and stride length (in cm)
Time Frame: During the entire gait cycle while walking on the CAREN system, during the only study visit moment (e.g. 6 months till 10 years after surgery).
|
Step width and stride length (in cm)
|
During the entire gait cycle while walking on the CAREN system, during the only study visit moment (e.g. 6 months till 10 years after surgery).
|
Time of the gait cycle spent in stance (in seconds)
Time Frame: During the entire gait cycle while walking on the CAREN system, during the only study visit moment (e.g. 6 months till 10 years after surgery).
|
Stance phase (in seconds)
|
During the entire gait cycle while walking on the CAREN system, during the only study visit moment (e.g. 6 months till 10 years after surgery).
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL56402.068.16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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