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Movement Pattern Training in People With Intra-articular, Prearthritic Hip Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02913222
Recruitment Status : Active, not recruiting
First Posted : September 23, 2016
Last Update Posted : January 30, 2020
Sponsor:
Collaborators:
University of Pittsburgh
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Chronic Hip Joint Pain Prearthritic Hip Disease Other: Rehabilitation Not Applicable

Detailed Description:

Significance: Intra-articular, prearthritic hip disorders (PAHD) result in substantial dysfunction in young adults and are proposed precursors to hip osteoarthritis. The number of surgical procedures to treat PAHD has grown exponentially in the past decade, despite the lack of high level evidence to guide treatment decisions. The potential exists for surgery to become standard treatment before rigorous investigation of treatment options has been completed. This trend may be partially due to a lack of evidence related to rehabilitation. Although some authors believe rehabilitation can improve function in people with PAHD, others state that rehabilitation is contra-indicated and recommend surgery as the best option. There are no published clinical trials to support or refute either opinion, therefore little is known about the comparative effectiveness of rehabilitation.

Innovation: The investigators' long term goal is to develop effective treatment strategies for people with PAHD that will improve function and prevent or delay the onset of OA. Movement pattern training is an innovative rehabilitation approach designed to reduce stresses on the hip joint by optimizing the biomechanics of functional tasks through task-specific instruction. Preliminary work suggests that abnormal movement patterns may be associated with PAHD and that movement pattern training may be an effective treatment approach, however comparison to standard rehabilitation has not been completed.

Purpose: This study was designed to assess the feasibility of conducting a multicenter randomized clinical trial (RCT) to determine the efficacy of movement pattern training compared to standard rehabilitation for people with PAHD. Participants enrolled at Washington University and University of Pittsburgh will be randomized into one of two treatment groups, movement pattern training or standard rehabilitation. In addition to assessing feasibility of the trial, preliminary estimates of effect sizes for treatment outcomes will be obtain in preparation for the future definitive trial. Post-treatment improvements in patient-reported function as measured by the Hip disability and Osteoarthritis Outcome Score and hip adduction motion during functional tasks, a proposed mechanistic factor associated with PAHD will be assessed. Upon completion of this study, the investigators will be positioned to implement a multicenter RCT to definitively assess the efficacy of movement pattern training.

Impact: Ultimately, if movement pattern training is determined to be effective, it will provide a relatively inexpensive alternative to surgical intervention. Further, the theoretical concepts of movement pattern training could be used to possibly serve a role in injury prevention, as well as optimize post-surgical outcomes in those who do require surgery.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Movement Pattern Training in People With Intra-articular, Prearthritic Hip Disorders
Actual Study Start Date : February 4, 2017
Actual Primary Completion Date : December 12, 2018
Estimated Study Completion Date : January 21, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Movement Pattern Training (MPT)
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
Comparison of two rehabilitation approaches
Other Names:
  • Physical Therapy
  • Therapeutic exercise

Active Comparator: Standard Rehabilitation
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
Comparison of two rehabilitation approaches
Other Names:
  • Physical Therapy
  • Therapeutic exercise




Primary Outcome Measures :
  1. Percentage of participants who are adherent to treatment attendance [ Time Frame: at 13 weeks after participation in treatment ]
    Percentage of study participants who attend 90% of the supervised treatment sessions


Secondary Outcome Measures :
  1. Improvement in function using the Hip disability and Osteoarthritis Outcome Score (HOOS) Activities in Daily Living subscale [ Time Frame: at 13 weeks after participation in treatment ]
    Patient reported outcome measure to quantify activity limitations due to hip pain

  2. Improvement in Hip disability and Osteoarthritis Outcome Score (HOOS) Symptoms subscale [ Time Frame: at 13 weeks after participation in treatment ]
    Patient reported outcome measure to quantify limitations due to hip symptoms



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02913222


Locations
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United States, Missouri
Program in Physical Therapy, Washington University
Saint Louis, Missouri, United States, 63108
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15219
Sponsors and Collaborators
Washington University School of Medicine
University of Pittsburgh
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Marcie Harris-Hayes, DPT, MSCI Washington University School of Medicine
Principal Investigator: Kelley Fitzgerald, PhD University of Pittsburgh

Additional Information:
Publications:

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02913222    
Other Study ID Numbers: R21HD086644-01A1-201609106
R21HD086644-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Washington University School of Medicine:
femoroacetabular impingement
labral tear
rehabilitation
Additional relevant MeSH terms:
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Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms