- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02368483
Conservative Treatment in Patients With Symptomatic Femoroacetabular Impingement
June 14, 2019 updated by: Nicola Maffiuletti, Schulthess Klinik
The Effectiveness of Neuromuscular Training of the Lower Limb Muscles in Reducing the Hip Symptoms in Patients With Symptomatic Femoroacetabular Impingement: a Prospective Intervention Study
This is a single-group, prospective, intervention study.
A total of 30 participants with unilateral symptomatic femoroacetabular impingement will be included into the study.
The intervention consists in neuromuscular training for the lower limb muscles (12 weeks, 2 times/week supervised training, 2 times/week home training).
The training includes physical exercises routinely used worldwide in clinical settings.
No control intervention group was included into the study because nowadays there is no standard conservative treatment for patients with symptomatic femoroacetabular impingement.
Assessments will be performed at (1) baseline, (2) mid-intervention, (3) end-intervention, and (4) follow-up.
Clinical, functional, neuromuscular and self-reported parameters will be collected during assessments.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Zurich, Switzerland, 8008
- Schulthess Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of unilateral symptomatic FAI according to clinical, radiographic and magnetic resonance imaging criteria
- Living place: Canton of Zurich or neighbouring Cantons
- Signed written informed consent to participate into the study
Exclusion Criteria:
- Previous hip surgery
- Any surgery to the lower limbs in the prior 6 months
- Congenital/developmental dysplasia
- Hip osteoarthritis
- Initiation of opioid analgesia and corticosteroid injection for hip pain within the prior 30 days
- BMI >35 kg/m2
- Significant cardiorespiratory diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Neuromuscular training
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Neuromuscular training for the hip and lower limb muscles.The training program is divided into 3 phases, and includes specific exercises for improving the hip range of motion, muscle strength of the hip and lower limb muscles, as well as the trunk stability and coordination.
The intervention lasts 12 weeks.
Patients will train 2 times/week with a physical therapist and 2 times/weeks alone at home.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hip Function as measured using the Hip Outcome Score questionnaire
Time Frame: Change from Baseline in Hip Function at 12 weeks
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Hip Function was assessed using the Hip Outcome Score.
The Hip Outcome score is a questionnaire used to evaluate hip function during daily and sport activities.
Two independent scores are obtained: one for activities of daily living and one for sport activities.
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Change from Baseline in Hip Function at 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hip Muscle Strength as measured using dynamometry
Time Frame: Change from Baseline in Hip Muscle Strength at 12 weeks
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Hip abduction, adduction, internal rotation and external rotation isometric maximal voluntary contraction strength is evaluated with hand-held dynamometry.
Hip flexion and extension isometric maximal voluntary contraction strength is evaluated with isokinetic dynamometry.
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Change from Baseline in Hip Muscle Strength at 12 weeks
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Movement Control Quality as measured using a visual rating scale
Time Frame: Change from Baseline in Movement Control Quality at 12 weeks
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Overall body movement pattern quality is visually assessed during the performance of 5 lower extremity functional tests (single-leg squat, lunge, hop lunge, single-leg bridge, single-leg ventral plank).
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Change from Baseline in Movement Control Quality at 12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2014
Primary Completion (Actual)
March 1, 2017
Study Completion (Actual)
March 1, 2017
Study Registration Dates
First Submitted
January 29, 2015
First Submitted That Met QC Criteria
February 14, 2015
First Posted (Estimate)
February 23, 2015
Study Record Updates
Last Update Posted (Actual)
June 18, 2019
Last Update Submitted That Met QC Criteria
June 14, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FAI conservative treatment 1
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.
Clinical Trials on Symptomatic Femoroacetabular Impingement
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Ottawa Hospital Research InstituteCompleted
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Ottawa Hospital Research InstituteCompletedFemoroacetabular Hip Impingement SyndromeCanada
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Ramsay Générale de SantéRamsay santéRecruiting
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Horsens HospitalUniversity of Aarhus; La Trobe UniversityNot yet recruitingFemoroacetabular Impingement
-
American Hip InstituteStryker OrthopaedicsRecruitingFemoroacetabular ImpingementUnited States
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Hospital for Special Surgery, New YorkNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)RecruitingFemoroacetabular ImpingementUnited States
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Universitaire Ziekenhuizen KU LeuvenActive, not recruitingFemoroacetabular ImpingementBelgium
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McMaster UniversityCanadian Institutes of Health Research (CIHR); McMaster Surgical Association; Arthroscopy Association of North America and other collaboratorsActive, not recruitingFemoroacetabular ImpingementCanada, Netherlands, Korea, Republic of
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The Hawkins FoundationTerminated
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Peking University Third HospitalCompletedFemoroacetabular ImpingementChina
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