Functional Movement Retraining After Hip Replacement (FMR-THA)
9. januar 2017 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
15
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
North Carolina
-
Durham, North Carolina, Forente stater, 27705
- Duke University Medical Center
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Durham, North Carolina, Forente stater, 27705
- Durham VA Medical Center, Durham, NC
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
19 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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).
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Hip Disability and Osteoarthritis Outcomes Score (HOOS) - Activities of Daily Living Scale
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Satisfaction With Physical Function Questionnaire
Tidsramme: 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.
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Change between Pre-intervention (post-surgery) to post-intervention (15 weeks post-surgery)
|
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Global Assessment of Hip Symptom Change
Tidsramme: 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)
|
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Change in Objective Functional Test: Timed Get Up-and-go
Tidsramme: 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.
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Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
|
|
Change in Objective Functional Test: Sit to Stand
Tidsramme: 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)
|
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Change in Objective Functional Test: Walking Speed
Tidsramme: 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)
|
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Change in Objective Functional Test: Stair Climbing
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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).
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Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)
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Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mai 2014
Primær fullføring (Faktiske)
1. september 2015
Studiet fullført (Faktiske)
1. desember 2016
Datoer for studieregistrering
Først innsendt
5. juni 2013
Først innsendt som oppfylte QC-kriteriene
11. juni 2013
Først lagt ut (Anslag)
14. juni 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
28. februar 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. januar 2017
Sist bekreftet
1. januar 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- O1033-P
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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