Functional Movement Retraining After Hip Replacement (FMR-THA)
2017年1月9日 更新者：VA Office of Research and Development
Functional Movement Retraining After Hip Arthroplasty in Veterans: Pilot Study
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
15
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
North Carolina
-
Durham、North Carolina、美国、27705
- Duke University Medical Center
-
Durham、North Carolina、美国、27705
- Durham VA Medical Center, Durham, NC
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
19年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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).
|
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).
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Hip Disability and Osteoarthritis Outcomes Score (HOOS) - Activities of Daily Living Scale
大体时间：Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
|
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 was defined as pre-intervention minus post-intervention.
Therefore a negative change score indicates improvement over time.
|
Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
|
|
Change in Hip Disability and Osteoarthritis Outcomes Score (HOOS) - Pain Scale
大体时间：Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
|
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 was defined as pre-intervention minus post-intervention.
Therefore a negative change score indicates improvement over time.
|
Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
|
|
Change in Hip Disability and Osteoarthritis Outcomes (HOOS) Score - Sport Subscale
大体时间：Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
|
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 was defined as pre-intervention minus post-intervention.
Therefore a negative change score indicates improvement over time.
|
Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
|
|
Change in Hip Disability and Osteoarthritis Outcomes (HOOS) Score - Symptom Subscale
大体时间：Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
|
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 was defined as pre-intervention minus post-intervention.
Therefore a negative change score indicates improvement over time.
|
Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
|
|
Change Hip Disability and Osteoarthritis Outcomes (HOOS) - Quality of Life Subscale
大体时间：Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
|
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 was defined as pre-intervention minus post-intervention.
Therefore a negative change score indicates improvement over time.
|
Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Satisfaction With Physical Function Questionnaire
大体时间：Change between Pre-intervention (post-surgery) to post-intervention (15 weeks post-surgery)
|
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.
The scale range is -15 to +15, with higher scores indicating more satisfaction with function.
Change was defined as post-intervention minus pre-intervention.
Therefore a positive change score indicates improvement over time.
|
Change between Pre-intervention (post-surgery) to post-intervention (15 weeks post-surgery)
|
|
Global Assessment of Hip Symptom Change
大体时间：15 weeks (post-intervention)
|
We will use the Patient Global Impression of Change scale to evaluate participants' perspectives on overall change in their joint pain in their (one) operative hip during the study period.
This single-item measure asks participants to describe their change in pain on a rating scale with the following 13 options: a little worse, somewhat worse, moderately worse, a good deal worse, a great deal worse, a very great deal worse, about the same, a little better, somewhat better, moderately better, a good deal better, a great deal better, a very great deal better.
The total scale range is -6 to +6.
Negative scores indicate greater perceived improvement.
|
15 weeks (post-intervention)
|
|
Change in Objective Functional Test: Timed Get Up-and-go
大体时间：Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
|
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 was defined as pre-intervention minus post-intervention.
Therefore a positive change score indicates improvement over time.
|
Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
|
|
Change in Objective Functional Test: Sit to Stand
大体时间：Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
|
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 was defined as pre-intervention minus post-intervention.
Therefore a positive change score indicates improvement over time.
|
Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
|
|
Change in Objective Functional Test: Walking Speed
大体时间：Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
|
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.
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 was defined as pre-intervention minus post-intervention.
Therefore a negative change score indicates improvement over time.
|
Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
|
|
Change in Objective Functional Test: Stair Climbing
大体时间：Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
|
The task of stair climbing has been found to be sensitive to change with interventions in individuals with knee OA.
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 was defined as pre-intervention minus post-intervention.
Therefore a positive change score indicates improvement over time.
|
Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
|
|
Change in University of California Los Angeles (UCLA) Activity Questionnaire
大体时间：Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
|
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 was defined as pre-intervention minus post-intervention.
Therefore a negative change score indicates improvement over time.
|
Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
|
|
Change in Harris Hip Score (HHS)
大体时间：Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
|
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; higher scores indicating better function.
The HHS has been shown to be a reliable and valid measure of hip function.
Change was defined as pre-intervention minus post-intervention.
Therefore a negative change score indicates improvement over time.
|
Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
|
|
Change in Lower Quarter Y-balance Test (YBT-LQ)
大体时间：Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
|
The YBT-LQ is a test of dynamic balance in unilateral stance .
It will be administered to all patients who pass a clearance test, which consists of being able to stand on one leg for 10 seconds.
The YBT-LQ 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.
NOTE: Only although 13 participants began the clearance test at both time points, only 5 participants were able to pass the clearance test required to do the YBT-LQ at 6 weeks.
Therefore we have not provided a change score for YBT-LQ since this would involve a very small number of participants, and we are concerned about validity of the results that would be presented since those who completed the test at 6 weeks may be a biased sample.
We therefore provide the difference (post minus pre) in the # of participants who completed the clearance test at 15 weeks (9) vs. 6 weeks (5).
|
Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年5月1日
初级完成 (实际的)
2015年9月1日
研究完成 (实际的)
2016年12月1日
研究注册日期
首次提交
2013年6月5日
首先提交符合 QC 标准的
2013年6月11日
首次发布 (估计)
2013年6月14日
研究记录更新
最后更新发布 (实际的)
2017年2月28日
上次提交的符合 QC 标准的更新
2017年1月9日
最后验证
2017年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Functional Movement Retraining的临床试验
-
University of Alabama at BirminghamThe Craig H. Neilsen Foundation; Lakeshore Foundation完全的
-
University of Southern CaliforniaNational Institute on Drug Abuse (NIDA); Eunice Kennedy Shriver National Institute of Child... 和其他合作者完全的