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)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 25 (estimated)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 8 Years – 21 Years
• Healthy volunteers: —

Summary

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 during gait. This study will evaluate 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 to investigate these two questions.

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.

Conditions

• Slipped Capital Femoral Epiphyses

Interventions

Type	Name	Description
OTHER	Not applicable for this study	Not applicable for this study

Timeline

• Start date: 2017-12-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2017-10-31
• Last updated: 2018-01-17

Locations

1 site across 1 country: Netherlands