Functional Movement Retraining After Hip Replacement

Arthroplasty, Replacement, Hip Clinical Trial

— FMR-THA  

Official title:

Functional Movement Retraining After Hip Arthroplasty in Veterans: Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01878175
• Other study ID #: O1033-P
• Status: Active, not recruiting
• Phase: N/A
• First received: June 5, 2013
• Last updated: June 24, 2016
• Start date: May 2014
• Est. completion date: December 2016

Study information

• Verified date: June 2016
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Total hip arthroplasty (THA) is a common surgical procedure among Veterans. It is most often used to treat hip osteoarthritis, which is more common among Veterans than the general population. Some patients continue to experience functional limitations after THA, and studies have shown that these patients still tend to put greater loads on the opposite leg, which can increase the risk of developing osteoarthritis in that leg. One likely reason for these post-surgical limitations is that rehabilitation is very minimal following this procedure. This project will involve development and preliminary testing of a functional movement retraining program, designed to help Veterans improve their function and biomechanics after THA. The project will also develop processes for delivering this program in Veterans' homes, to increase accessibility.

Description:

Rehabilitation following total hip arthroplasty (THA) is limited in scope, and some patients continue to exhibit functional limitations, as well as loading asymmetries that place them at risk for developing osteoarthritis in contralateral joints. The purpose of this study is to collect preliminary data to support a larger project that will examine the effectiveness of a 12-session functional movement retraining (FMR) program for Veterans following THA. A novel aspect of the FMR program is that it focuses not only on improving overall function but also normalizing side-to-side asymmetries in balance and strength via patient-specific tailoring of exercises. The program also involves telerehabilitation processes to improve access.

Participants will be n=15 patients scheduled for THA at the Durham VAMC, identified from electronic medical records. Participants will complete assessments pre-operatively, then approximately 6-weeks post-THA, at which time FMR program will begin. The 12 FMR sessions will optimally be delivered twice weekly for 6 weeks. However, to account for missed visits, the investigators will allow for 9 total weeks to complete the 12 sessions. Therefore follow-up assessments will be scheduled at 15-weeks post-THA for all participants. FMR sessions will be a combination of: 1.) in-person, on-site visits and telephone contacts with a licensed physical therapist and 2.) in-home telehealth visits by a telehealth technologist or physical therapy assistant. The FMR program will focus on improving lower extremity mobility, muscle stability and functional movement patterns. Participants will be instructed to perform a series of stretching exercises daily and strengthening exercises three times weekly. Exercises for each patient will be tailored according to results of the Lower Quarter Y-Balance Test (conducted at baseline and mid-way through the program), which assesses asymmetries between limbs and between anterior vs. posterior reach. Outcomes will include objective functional measures (timed up-and-go, sit-to-stand, walking speed, stair climb, Lower Quarter Y-Balance Test), self-reported pain and activity limitations (Hip disability and Osteoarthritis Outcome Score), and therapist-assessed function (Harris Hip Score). Basic descriptive statistics will be used to compare changes in each outcome (pre-operative to 15-week post-THA and 6-week post THA to 15-week post-THA) and inform sample size estimates for a larger trial. The investigators will also assess various aspects of program feasibility (recruitment success, adherence, telerehabilitation processes) and collect in-depth qualitative information from both patients and therapists to assess aspects of the intervention that may need to be modified prior to a larger study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: December 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Veteran, Scheduled for hip arthroplasty at Durham, NC VA Medical Center

Exclusion Criteria:

• Dementia or other significant cognitive impairment;

• movement or motor neuron disorders (e.g., Parkinson's Disease, post-stroke neurological deficiencies);

• rheumatoid arthritis,

• fibromyalgia,

• or other systemic rheumatic disease;

• hospitalization for a stroke,

• myocardial infarction,

• heart failure,

• or coronary artery revascularization in the past 3 months;

• psychosis or current, uncontrolled substance abuse disorder;

• any other health conditions determined by the study team to be contraindications to performing the exercise program (e.g., mild home exercises);

• transportation or other limitations that would prevent visits to the Durham VAMC for the retraining program.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip

Intervention

Behavioral:
• Functional Movement Retraining
15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina
United States	Durham VA Medical Center, Durham, NC	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hip disability and osteoarthritis outcomes score (HOOS)	The HOOS is a validated outcome measure in patients with painful hip conditions. It contains 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.	Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)	No
Secondary	Change in Satisfaction with physical function questionnaire	This is a validated 5-item questionnaire that assesses patients' satisfaction with their ability to complete basic functional tasks that are often affected by lower extremity osteoarthritis (OA), including stair-climbing, walking, doing housework (light and heavy), and lifting and carrying.	Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)	No
Secondary	Global assessment of hip symptom change	We will use the Patient Global Impression of Change scale to evaluate participants' perspectives on overall changes in their joint pain during the study period. This single-item measure asks participants to describe their change in pain on a 7-point rating scale with the following options: "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," and "very much worse."	15 weeks (post-intervention)	No
Secondary	Change in Objective functional test: Timed get up-and-go	The timed get up-and-go test has demonstrated excellent reliability and correlates well with other standard measures such as gait speed, self-report and clinical report indices of function, and is predictive of who can safely ambulate. This test requires the participants to stand from a standard arm chair, walk 3 meters and then return to sitting in the same chair. Participants are asked to complete this as quickly and safely as possible, without the use of an assistive device.	Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)	No
Secondary	Change in Objective functional test: Sit to stand	The Sit-to-Stand Test has been reported to be a good indicator of postural control, fall risk, lower-extremity strength, and disability. During the sit-to-stand test participants will be asked to place their arms across their chest and keep their feet flat on the floor. They will then be asked to stand up and sit down 5 times as fast as they can. This will be repeated twice and the scores will be averaged for analysis.	Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)	No
Secondary	Change in Objective functional test: Walking speed	Gait speed is a global measure of disability and function and has been correlated with disease processes, fitness level, activities of daily living, and emotional states (48). Gait velocity changes are sensitive to improvements in mobility in adults and correspond directly with self-report of improvement in global assessment by subjects. In addition, gait speed is an imperative measure for integration to safe and effective community ambulatory status, and has been defined as a reflective measure of function. Walking speed will be determined as the average walking speed over a 3 meter walk. Participants will be asked to walk down a 10 meter walkway 7 times (while wearing standard footwear) to have their walking speed monitored using infrared photocells, while speed is monitored over the middle 3 meters. These seven trials will be averaged in order to determine walking speed at each of the three visits.	Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)	No
Secondary	Change in Objective functional test: Stair climbing	The task of stair climbing has been found to be sensitive to change with interventions in individuals with knee OA. We have chosen to use 12 steps, which is a standard practice in our laboratory, because this mirrors and average flight of stairs and therefore provides an evaluation of participants' ability to accomplish a basic life skill of walking one set of stairs. This measures the time it takes a participant to ascend and descend a flight of 12 steps (each step 18 cm high and 28 cm deep). Participants will be asked to complete the test as quickly as they felt safe and comfortable. The use of one handrail will be allowed if necessary, but patients will be encouraged to minimize their use of the handrail. One practice trial will be performed and the average of two additional tests will be used for analysis. The use of an assistive device will be allowed only if the subject will be unsafe or cannot complete the test without the use of the device.	Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)	No
Secondary	Change in University of California Los Angeles (UCLA) activity questionnaire	The UCLA scale shows a strong correlation with the other measures (r = -0.35 to 0.56 for THA; r = -0.55 to 0.23 for TKA) and discriminates between insufficiently and sufficiently active patients undergoing THA and TKA. The UCLA scale has good reliability, provides high completion rate, and shows no floor effects. It seems to be the most appropriate scale for assessment of physical activity levels in patients undergoing total joint arthroplasty. The UCLA scale is a simple scale ranging from 1 to 10. The patient indicates her or his most appropriate activity level, with 1 defined as 'no physical activity, dependent on others' and 10 defined as 'regular participation in impact sports.'	Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)	No
Secondary	Change in Harris hip score (HHS)	The HHS is the most widely used physician- or therapist-assessed measure of hip function following THA and associated rehabilitation. Although the HHS has also been used in a patient-report format, in this study we will obtain this measure via therapist report, to complement the patient-reported outcomes described above. This measure covers the domains of pain (severity and effects on activities and need for pain medication, function (daily activities and gait), deformity (hip flexion, adduction, internal rotation, and extremity length discrepancy) and range of motion (hip flexion, abduction, internal and external rotation, and adduction). The HHS includes 10 items, with a total score range of 0-100. The HHS has been shown to be a reliable and valid measure of hip function.	Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)	No
Secondary	Change in Lower quarter Y-balance test (YBT-LQ)	The YBT-LQ is a test of dynamic balance in unilateral stance that has been deemed to be reliable and valid. It will be administered to all patients who pass a clearance test, which consists of being able to sand on one leg for 10 seconds without loss of balance. Each participant will receive 3 attempts to complete this task. If they are able to complete the test on each leg they will complete the full YBT-LQ. The YBT-LQ is a derivative of the Star Excursion Balance test. This is performed for both left and right limbs. Any trial that is failed will be repeated with a maximum of 4 additional trials to be performed in each reach direction, anterior, posterior, and lateral.	Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)	No