NCT02368483

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2015

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 23, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

June 18, 2019

Status Verified

June 1, 2019

Enrollment Period

2.4 years

First QC Date

January 29, 2015

Last Update Submit

June 14, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hip Function as measured using the Hip Outcome Score questionnaire

    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.

    Change from Baseline in Hip Function at 12 weeks

Secondary Outcomes (2)

  • Hip Muscle Strength as measured using dynamometry

    Change from Baseline in Hip Muscle Strength at 12 weeks

  • Movement Control Quality as measured using a visual rating scale

    Change from Baseline in Movement Control Quality at 12 weeks

Study Arms (1)

Neuromuscular training

EXPERIMENTAL
Other: Neuromuscular training

Interventions

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.

Neuromuscular training

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schulthess Clinic

Zurich, 8008, Switzerland

Location

Related Publications (1)

  • Casartelli NC, Bizzini M, Maffiuletti NA, Sutter R, Pfirrmann CW, Leunig M, Naal FD. Exercise Therapy for the Management of Femoroacetabular Impingement Syndrome: Preliminary Results of Clinical Responsiveness. Arthritis Care Res (Hoboken). 2019 Aug;71(8):1074-1083. doi: 10.1002/acr.23728. Epub 2019 Jul 9.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 29, 2015

First Posted

February 23, 2015

Study Start

October 1, 2014

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

June 18, 2019

Record last verified: 2019-06

Locations