- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00924261
Age-Related Gait Changes and Hip Flexibility
2009년 9월 3일 업데이트: University of Virginia
Based on their preliminary quantitative gait findings suggesting that limited passive hip extension range is a key functionally limiting impairment affecting gait, the investigators propose a supervised, specific stretching exercise with the aim to improve both peak hip extension and overall gait performance.
While one goal is to demonstrate that reduced peak passive hip extension is a key, functionally significant, but reversible, impairment another is to improve our understanding of the relationship between impairment, functional limitation and gait ability.
연구 개요
상세 설명
- Test the hypothesis that both passive and dynamic hip extension during comfortable and fast walking speeds are reduced in the elderly groups compared to passive and dynamic peak hip extension in healthy young adults.
- Test the hypothesis, separately for each elderly group, controlling for co-factors, that there is greater change in step length in the treatment group compared to the control group, after controlling for co-variates. We also expect greater changes in dynamic hip peak extension, a reduction in anterior pelvic tilt, improvement in age-related reductions in peak ankle plantar flexion and ankle power generation, and in dynamic CoM-CoP moment arm during both comfortable and fast walking, and an increase in comfortable walking speed.
- Test the hypothesis separately for the frail elderly group who cannot independently perform IADL only, controlling for co-factors, that there is a greater change in secondary, non quantitative gait-parameters of the Timed Get Up and Go Test, Activities of Daily Living, Instrumental ADL function, fear of falling and number of falls during 6 months following intervention.
- Test the hypothesis that the created forward dynamic model can accurately predict in individual subjects, the actual effect of an increase in passive peak hip extension on dynamic peak hip extension, anterior pelvic tilt, peak ankle plantar flexion and step length.
연구 유형
중재적
등록 (예상)
250
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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Virginia
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Charlottesville, Virginia, 미국, 22903
- Department of Physical Medicine and Rehabilitation, University of Virginia
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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
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
Healthy Elderly Adult Subjects:
- 100 subjects aged 65 years and older will be recruited from the Charlottesville area.
- Participants will be asked to fill out a health questionnaire identical to that used for all preliminary studies. This questionnaire verifies that the participants meet the inclusion criteria for the proposed research project.
- After this initial health questionnaire screening, each participant will undergo a face-to-face history and physical examination screening.
Frail Elderly Subjects:
- 100 subjects aged 65 years and older who meet the criteria of not being able to function independently, which is considered to be frail, living within the greater Charlottesville area will be recruited for participation in the study.
Exclusion Criteria:
Healthy Elderly:
- acute medical illness,
- diagnosis or symptoms of unstable angina or congestive heart failure,
- pulmonary diagnosis or symptoms of emphysema, chronic obstructive disease or asthma and shortness of breath as a result of pulmonary diagnosis brought about by walking on a flat surface,
- advanced cancer,
- neurologic diagnosis including Parkinson's Disease, stroke, brain injury, cerebellar disease, myelopathy, myopathy, peripheral neuropathy, or active radiculopathy,
- major orthopedic diagnosis in the lower back, pelvis, or lower extremities, including hip or other fracture since the age of 50, fused joint, joint replacement, or amputation,
- severe osteoarthritis or rheumatoid arthritis or active joint or musculoskeletal pain in the back or lower extremities occurring at rest or with walking,
- severe osteoporosis with a history of a fragility fracture occurring in the past 12 months, and
- regular use of an assistive device for walking.
Exclusion criteria per physical examination will be:
- physical signs of congestive heart failure,
- muscle weakness (less than 4/5 manual muscle test strength in lower extremities or focal findings of 1/5 strength difference between sides or upper and lower extremities), absent knee extensor reflexes or positive Babinski responses,
- corrected visual acuity worse than 20/100 or presence of a field defect,
- poor mental state defined with a Mini-Mental Status Examination score less than or equal to 24/30,133
- orthostatic hypotension (greater than 20mmHg decline in systolic blood pressure from supine to standing at one minute), and
- unilateral sensory deficit in lower extremities, bilateral sensory loss in stocking distribution, proprioception less than 75% correct in identifying great toe position, or vibration (from with a 128Hz tuning fork) perceived for less than 10 seconds at either the great toe or medial malleolus in either extremity.
Frail Elderly (who do not Function Independently):
- are unable to walk independently (i.e., unable to walk without the assistance of another person), or
- have either an acute medical condition or a chronic underlying medical condition which would make it unfeasible or unsafe to participate.
Regular use of an assistive device, such as a cane, for walking is not an exclusion criterion as long as:
- when using the device, the subject does not require the assistance of another person and
- the subject can walk without the assistive device (with supervisory, but not physical assistance if needed) for the length of the testing walkway, ten times (with rest periods between) at both his/her comfortable walking speed and at a faster walking speed.
Based upon the questionnaire or medical history, the following specific exclusion criteria will be used:
- acute medical illness,
- symptoms of angina or dyspnea brought about by walking on a flat surface,
- hip or knee replacement surgery or hip fracture in the previous six months,
- advanced cancer and/or life expectancy of less than 12 months,
- dementia or other illness characterized by cognitive impairment.
Based upon physical examination, subjects will be excluded if they have:
- physical signs of congestive heart failure,
- cognitive impairment defined as a Mini-Mental Status Examination score less than or equal to 24/30133 or
- orthostatic hypotension (greater than 20mm Hg decline in systolic blood pressure from supine to standing at one minute).
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Hip Stretching
Kneeling Hip flexor stretch - 3 minutes a day, daily, for 10 weeks
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Hip flexor stretch daily for 3 min x 10 weeks
다른 이름들:
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실험적: Shoulder Stretch
Shoulder Stretch - 3 minutes daily for 10 weeks
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Shoulder Adduction stretch - 3 minutes, daily, for 10 weeks
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Hip Extension
기간: 10 weeks
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10 weeks
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Hip Flexibility
기간: 10 weeks
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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: Diedre C Kerrigan, MD, MS, University of Virginia
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
2007년 2월 1일
기본 완료 (예상)
2009년 6월 1일
연구 완료 (예상)
2009년 12월 1일
연구 등록 날짜
최초 제출
2009년 6월 16일
QC 기준을 충족하는 최초 제출
2009년 6월 17일
처음 게시됨 (추정)
2009년 6월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2009년 9월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2009년 9월 3일
마지막으로 확인됨
2009년 9월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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