- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT06657989
건강한 노인을 위한 반응 균형 훈련의 최적 강도
Falls in daily life are a serious risk for older adults. A new type of balance training, called reactive balance training (RBT) involves people losing balance many times so that they can practice fast balance reactions, like stepping reactions. Differences in training program features might explain differences in the results of previous RBT studies. Training intensity is the difficulty or challenge of the training program. It would be valuable to know if high-intensity RBT improves balance reactions quickly. The main goal of this study is to see if more intense RBT improves balance reactions faster than less intense RBT. The investigators will compare how quickly people improve balance reactions between high- and moderate-intensity RBT, and between RBT and a control program that does not include RBT. The investigators will also test if the improvements in balance reactions last after the training program is over. The secondary goals are to understand exactly how balance reactions improve with training, and to determine if people who complete RBT improve their general balance skills, and falls efficacy more than people who do not complete RBT.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Avril Mansfield, PhD
- 전화번호: 7831 416-597-3422
- 이메일: avril.mansfield@uhn.ca
연구 연락처 백업
- 이름: David Jagroop
- 전화번호: 7614 416-597-3422
- 이메일: david.jagroop@uhn.ca
연구 장소
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Ontario
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Toronto, Ontario, 캐나다, M5G 2A2
- 모병
- University Health Network
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연락하다:
- David Jagroop
- 전화번호: 7614 416-597-3422
- 이메일: david.jagroop@uhn.ca
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Community-dwelling older adults (65-80 years old)
Exclusion Criteria:
- Unable to stand independently without upper-limb support for >30 seconds and/or walk independently (without a gait aid) for ≥10 metres;
- Diagnosed neurological condition that could affect balance control (e.g., stroke, Parkinson's disease);
- Score below normative values on the Montreal Cognitive Assessment;
- Score below age-matched normative values for sensory and motor function, as assessed using the FallScreen battery;
- Have insufficient English language comprehension such that they cannot understand instructions;
- Have contraindications to reactive balance training such as severe osteoporosis; and/or
- Are currently attending physiotherapy or supervised exercise.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: High intensity reactive balance training
Participants will complete 5 1-hour training sessions over 11 days. During each training session, participants will complete 36 multi-directional (left-, right-, and forward-fall) perturbations. Participants assigned to high-intensity RBT will experience perturbations at 150% of the multi-step threshold; for example, for a multi-step threshold of 2 m/s^2 the high intensity perturbation will be 3 m/s^2. |
Reactive balance training involves clients experiencing repeated balance perturbations so that they can practice and improve control of reactions to avoid falling after a loss of balance.
다른 이름들:
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활성 비교기: Moderate intensity reactive balance training
Participants will complete 5 1-hour training sessions over 11 days. During each training session, participants will complete 36 multi-directional (left-, right-, and forward-fall) perturbations. Participants assigned to moderate-intensity RBT will experience perturbations at 100% of the multi-step threshold; for example, for a multi-step threshold of 2 m/s^2 the high intensity perturbation will be 2 m/s^2. |
Reactive balance training involves clients experiencing repeated balance perturbations so that they can practice and improve control of reactions to avoid falling after a loss of balance.
다른 이름들:
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가짜 비교기: Walking control group
Participants assigned to the walking control group will complete 36 trials of unperturbed walking in each training session. |
Overground walking |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of reactive steps
기간: Two weeks
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Learning rate for number of steps to recover from 'backward fall' balance perturbations |
Two weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Step initiation time
기간: One week and 12 weeks post-training
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Time from perturbation onset time to foot off time |
One week and 12 weeks post-training
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Step execution time
기간: One week and 12 weeks post-training
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Time from foot off to foot contact of the first step |
One week and 12 weeks post-training
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Step length
기간: One week and 12 weeks post-training
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Difference in foot position from foot off to foot contact |
One week and 12 weeks post-training
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Braking impulse
기간: One week and 12 weeks post-training
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Antero-posterior shear force generated over time on step contact |
One week and 12 weeks post-training
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Mechanical margin of stability
기간: One week and 12 weeks post-training
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Distance between the extrapolated centre of mass (incorporating centre of mass position and velocity) and the edge of the base of support |
One week and 12 weeks post-training
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Balance evaluation systems test
기간: One week and 12 weeks post-training
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Scale ranges from 0-100, with higher scores indicating better outcome |
One week and 12 weeks post-training
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Falls efficacy scale - International
기간: One week, 12 weeks, and 12 months post-training
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Scale range: 10-100; higher values indicate worse outcome |
One week, 12 weeks, and 12 months post-training
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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낙상사고 발생
기간: 12개월 후 훈련
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12개월 후 훈련
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넘어질 염려가 있는 참가자 수
기간: 훈련 후 1주, 12주, 12개월
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훈련 후 1주, 12주, 12개월
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낙상 우려로 인해 활동이 제한된 참가자 수
기간: 훈련 후 1주, 12주, 12개월
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훈련 후 1주, 12주, 12개월
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Fall incidence
기간: 12 months post-training
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Falls in daily life |
12 months post-training
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5-level EuroQoL health status measure (EQ-5D-5L)
기간: One week, 12 weeks, and 12 months post-training
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Scale range for descriptive component: 5-25, higher values indicate worse outcome; Scale range for visual analogue scale: 0-100, higher values indicate better outcome |
One week, 12 weeks, and 12 months post-training
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공동 작업자 및 조사자
수사관
- 수석 연구원: Avril Mansfield, PhD, University Health Network, Toronto
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
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. .