NCT02913222

Brief Summary

Intra-articular, prearthritic hip disorders (PAHD) result in substantial dysfunction in young adults and are proposed precursors to hip osteoarthritis (OA). Effective treatment of PAHD is needed to improve function in the young adult and prevent or delay the onset of hip OA, however evidence related to treatment of PAHD is limited. This research will provide the foundation for a future clinical trial to assess the efficacy of movement pattern training, an innovative rehabilitation approach for the treatment of PAHD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 23, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

February 4, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
4 months until next milestone

Results Posted

Study results publicly available

May 12, 2020

Completed
Last Updated

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

1.9 years

First QC Date

September 15, 2016

Results QC Date

April 14, 2020

Last Update Submit

March 23, 2023

Conditions

Keywords

femoroacetabular impingementlabral tearrehabilitation

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Who Are Adherent to Treatment Attendance

    Percentage of study participants who attend 90% (9/10) of the supervised treatment sessions.

    Immediately after treatment (13 weeks after baseline)

Secondary Outcomes (2)

  • Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Activities in Daily Living Subscale From Baseline to Post-treatment (13 Weeks)

    Immediately after treatment (13 weeks after baseline)

  • Change in Hip Disability and Osteoarthritis Outcome Score (HOOS) Symptoms Subscale From Baseline to Post-treatment (13 Weeks)

    Immediately after treatment (13 weeks after baseline)

Other Outcomes (28)

  • Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Pain Subscale From Baseline to Post-treatment (13 Weeks)

    Between Baseline and Immediately after treatment (13 weeks after baseline)

  • Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Sport Subscale From Baseline to Post-treatment (13 Weeks)

    Between Baseline and Immediately after treatment (13 weeks after baseline)

  • Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Quality of Life (QOL) Subscale From Baseline to Post-treatment (13 Weeks)

    Between Baseline and Immediately after treatment (13 weeks after baseline)

  • +25 more other outcomes

Study Arms (2)

Movement Pattern Training (MPT)

EXPERIMENTAL

Treatment: 10 sessions over 12 weeks and a home program provided by a physical therapist. Treatment includes assessment of patient goals and patient education. Movement Pattern Training (MPT) will focus on task-specific training to improve lower extremity movement patterns during basic tasks, such as sit to stand and stairs, and reported patient-specific tasks. Patient education will include instruction in abnormal movement patterns and methods to optimize movement patterns during each task. Exercises will include repeated practice of tasks using optimized movement patterns. Verbal cues and visual aids will be used to assist the participant. Difficulty of the task-specific activities will be progressed by varying repetitions performed, increasing load or changing the support surface.

Other: Rehabilitation

Standard Rehabilitation

ACTIVE COMPARATOR

Treatment: 10 sessions over 12 weeks and a home program provided by a physical therapist. Treatment includes assessment of patient goals and patient education. For the Standard Rehabilitation, focus will be on progressive lower extremity and trunk strengthening and lower extremity flexibility. Patient education will include instruction to modify intensity, frequency or duration of patient-specific tasks. Using current clinical practice guidelines and previous reports, strengthening and flexibility exercises will be prescribed and progressed by varying the repetitions performed or increasing the load.

Other: Rehabilitation

Interventions

Comparison of two rehabilitation approaches

Also known as: Physical Therapy, Therapeutic exercise
Movement Pattern Training (MPT)Standard Rehabilitation

Eligibility Criteria

Age15 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • be 15-40 years old
  • report deep hip joint or anterior groin pain, confirmed upon physical exam
  • report pain \> 3/10 and present \> 3 months
  • demonstrate functional limitation with modified Harris Hip Score \<90.

You may not qualify if:

  • previous hip surgery, fracture, pelvic/hip infection
  • pain due to high impact trauma
  • inflammatory disease, e.g. rheumatoid arthritis, gout
  • neurological involvement affecting balance
  • age \<15 or \>40
  • Slipped Capital Femoral Epiphysis (SCFE) or Legg-Calve-Perthes Disease (LCP)
  • pain, numbness or tingling that radiates into the thigh
  • known pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Program in Physical Therapy, Washington University

St Louis, Missouri, 63108, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15219, United States

Location

Related Publications (5)

  • Harris-Hayes M, Steger-May K, Bove A, Foster S, Mueller MJ, Clohisy JC, Fitzgerald GK. Sustained Outcomes Following Movement Pattern Training or Strengthening/Flexibility Among Patients with Prearthritic Hip Disorders: Results of a Pilot Multicenter Randomized Clinical Trial. Accepted for OARSI World Congress on Osteoarthritis, April 2020.

    BACKGROUND
  • Foster SN, Harris MD, Hastings MK, Mueller MJ, Salsich GB, Harris-Hayes M. Static Ankle Dorsiflexion and Hip and Pelvis Kinematics During Forward Step-Down in Patients With Hip-Related Groin Pain. J Sport Rehabil. 2020 Dec 8;30(4):638-645. doi: 10.1123/jsr.2020-0140.

    PMID: 33291065BACKGROUND
  • Koch K, Semciw AI, Commean PK, Hillen TJ, Fitzgerald GK, Clohisy JC, Harris-Hayes M. Comparison between movement pattern training and strengthening on muscle volume, muscle fat, and strength in patients with hip-related groin pain: An exploratory analysis. J Orthop Res. 2022 Jun;40(6):1375-1386. doi: 10.1002/jor.25158. Epub 2021 Aug 18.

  • Harris-Hayes M, Steger-May K, M Bove A, Mueller MJ, Clohisy JC, Fitzgerald GK. One-year outcomes following physical therapist-led intervention for chronic hip-related groin pain: Ancillary analysis of a pilot multicenter randomized clinical trial. J Orthop Res. 2021 Nov;39(11):2409-2418. doi: 10.1002/jor.24985. Epub 2021 Mar 2.

  • Harris-Hayes M, Steger-May K, Bove AM, Foster SN, Mueller MJ, Clohisy JC, Fitzgerald GK. Movement pattern training compared with standard strengthening and flexibility among patients with hip-related groin pain: results of a pilot multicentre randomised clinical trial. BMJ Open Sport Exerc Med. 2020 Mar 23;6(1):e000707. doi: 10.1136/bmjsem-2019-000707. eCollection 2020.

Related Links

MeSH Terms

Conditions

Femoracetabular Impingement

Interventions

RehabilitationPhysical Therapy ModalitiesExercise Therapy

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Limitations and Caveats

This is a pilot study to determine preliminary estimates of treatment effects for movement pattern training and standard rehabilitation. We cannot make definitive statements regarding efficacy of Movement Pattern Training or Standard treatment.

Results Point of Contact

Title
Marcie Harris-Hayes, PT, DPT, MSCI, Professor, Physical Therapy and Orthopaedic Surgery
Organization
Washington University School of Medicine

Study Officials

  • Marcie Harris-Hayes, DPT, MSCI

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR
  • Kelley Fitzgerald, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2016

First Posted

September 23, 2016

Study Start

February 4, 2017

Primary Completion

December 12, 2018

Study Completion

December 31, 2019

Last Updated

March 27, 2023

Results First Posted

May 12, 2020

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations