Randomized Controlled Trial of Dynamic Balance Training in People With Knee Osteoarthritis
2016년 6월 5일 업데이트: University of British Columbia
The Effect of Dynamic Balance Training on Balance and Physical Function in Those With Knee Osteoarthritis
There is a high prevalence of falls in those with knee osteoarthritis (OA) compared to healthy older adults.
Balance is a key element of function that allows individuals to maintain posture and respond to perturbations, and poor balance control, a risk factor for falls, has been noted in those with knee OA.
There is a lack of research guiding treatment for balance deficits in knee OA, with interventions aimed at improving balance deficits in those with knee OA having mixed results.
Targeted dynamic balance interventions in other patient populations have been shown to significantly improve dynamic balance control and physical function.
If results similar to such populations can be achieved, such a program may produce a significant reduction in functional disability in the knee OA population and improve quality of life.
The purpose of this study is to examine the effect of a 10-week targeted dynamic balance intervention on dynamic balance and physical function in people with knee OA.
This will be a randomized controlled trial (RCT).
연구 개요
연구 유형
중재적
등록 (실제)
40
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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British Columbia
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Vancouver, British Columbia, 캐나다, V6T 1Z3
- Motion Analysis and Biofeedback Laboratory, The University of British Columbia
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
50년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- age 50 - 80 years (to meet the American College of Rheumatology clinical definition of OA)
- radiographically confirmed knee OA in the medial compartment of the tibiofemoral joint
- predominance of pain/tenderness over the medial (inside) region of the knee
Exclusion Criteria:
- articular cartilage degradation in the lateral tibiofemoral compartment greater than the medial
- inflammatory arthritic condition
- history of knee or hip replacement surgery
- recent use of corticosteroids (oral or via injection, within last 6 months)
- pain originating predominantly from the patellofemoral joint
- inability to ambulate without a gait aid
- non-English speaking
- recent (within 6 months) arthroscopic knee surgery
- significant hip or back pain (limits the ability to perform the testing)
- Neurological, musculoskeletal or other condition that affects movement ability or balance (i.e. stroke, diabetes, Parkinson's, heart attack, multiple sclerosis, fibromyalgia)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: Wait list
Wait list control group.
Participants will be placed on the wait list and asked to maintain their current routine and level of activity during the 10 week period.
Control group participants will receive the dynamic balance training program in a single training session after the followup (second testing session at 10 weeks).
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실험적: Treatment (balance training)
Targeted dynamic balance training.
Dynamic balance training will consist of progressive exercise training over three phases, with exercises emphasising dynamic balance control, muscle strength and proprioception.
Exercises will be performed four times per week for ten weeks.
Exercises will be taught and supervised by a trained kinesiologist.
Difficulty of exercises will be increased progressively over time by increasing resistance, time of timed exercises, and distance of walking exercises.
Exercises will be progressed to different exercises in each new phase (total 3 phases).
Participants will complete six treatment sessions at the university (during weeks 1, 2, 3, 5, 7, and 9) that will be included in the total number of sessions per week.
All other sessions will be performed at home.
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Participants in this study group will complete dynamic balance training exercises four times per week, for ten weeks.
Exercise sessions at the university will last approximately one hour, and home exercise sessions will take approximately 30 minutes to complete.
Exercises will emphasize dynamic balance control, muscle strength and proprioception and will be progressed over three phases during the ten weeks (with more difficult exercises phased in, and exercises that have been mastered phased out).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in dynamic balance and mobility from baseline
기간: 0, 10 weeks
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The Community Balance and Mobility Scale (CB&M) will be used to assess dynamic balance and mobility.
The CB&M is a scale designed to assess dynamic balance and mobility and is administered by a trained assessor.
The scale consists of 13 items including bending, walking, turning, and stair descent, with a maximum possible score of 96 and minimum score of 0. The scale has been validated and deemed reliable for use in the knee osteoarthritis population.
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0, 10 weeks
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Change in self-reported physical function from baseline
기간: 0, 10 weeks
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The Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) will be used to assess self-reported physical function.
The WOMAC physical function subscale consists of 17 questions assessing physical function capabilities during activities of daily living.
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0, 10 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in knee pain from baseline
기간: 0, 10 weeks
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Average pain over the previous week will be assessed using an 11-point numerical rating scale (0 = no pain; 10 = worst pain possible).
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0, 10 weeks
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Change in fear of pain from baseline
기간: 0, 10 weeks
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The Brief Fear of Movement Scale will be used to assess fear of pain.
This scale is based on the widely used Tampa Scale of Kinesiophobia and contains 6 questions that evaluate fear of pain, movement and re-injury.
The scale has been validated in individuals with OA.
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0, 10 weeks
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Change in self-reported physical activity level from baseline
기간: 0, 10 weeks
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The Physical Activity Scale for the Elderly score (PASE) will be used to measure self-reported physical activity level.
This valid and reliable self-report instrument measures the type and level of recreational and occupational physical activity in the previous week.
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0, 10 weeks
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Change in knee joint proprioception from baseline
기간: 0, 10 weeks
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Knee joint proprioception will be measured using a knee joint repositioning task, previously used in those with OA to assess joint proprioception.
Proprioception will be assessed in three randomly chosen target positions (15°, 30°, and 60° of knee flexion) while the participant is seated on an isokinetic dynamometer.
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0, 10 weeks
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Change in muscle strength from baseline
기간: 0, 10 weeks
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Maximal concentric and eccentric muscle strength of the plantarflexors, quadriceps, and hamstrings will be measured using the same isokinetic dynamometer as for the knee joint repositioning task.
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0, 10 weeks
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Change in knee joint range of motion from baseline
기간: 0, 10 weeks
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Range of motion will be measured using a goniometer, similar to other studies of knee OA.
Participants will be asked to flex and extend their knee joint while supine.
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0, 10 weeks
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Ratio of number of exercise sessions attended to the maximum
기간: 10 weeks
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Adherence to the exercise program will be assessed by calculating the number of exercise sessions attended divided by the maximum number of sessions.
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10 weeks
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Number of participants with adverse events
기간: 10 weeks
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Adverse events experienced due to the intervention (i.e.
increased knee pain) will be recorded weekly by participants.
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10 weeks
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Change in medication use
기간: 10 weeks
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Any change in pharmacological use by participants will be recorded.
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10 weeks
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Change in co-interventions
기간: 10 weeks
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Other therapies that participants may be pursuing will be recorded.
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10 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Michael A Hunt, PT, PhD, University of British Columbia
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2014년 6월 1일
기본 완료 (실제)
2015년 12월 1일
연구 완료 (실제)
2015년 12월 1일
연구 등록 날짜
최초 제출
2014년 4월 1일
QC 기준을 충족하는 최초 제출
2014년 4월 1일
처음 게시됨 (추정)
2014년 4월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 6월 7일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 6월 5일
마지막으로 확인됨
2016년 6월 1일
추가 정보
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