- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04050774
Standing Balance Control Across the Lifespan (BaCoMech)
Balance Control Mechanisms During Perturbed Standing Across the Lifespan
Falls are the leading cause of nonfatal injuries in children and elderly. To understand the causes of falling in these populations, fundamental knowledge of how ageing affects balance control is of utmost importance.
In general, two biomechanical mechanisms allow people to control balance; 1.moving the center of pressure within the base of support using ankle muscle activation; 2.counter-rotating segments around the center of mass. To understand how balance is controlled differently across the lifespan, 4 age groups (each N=20) will be compared to each other; i.e. prepubertal children (6-9y), postpubertal children (15-17y), young adults (18-24y), healthy non-falling older adults (65-80y). .
A force plate platform combined with 3D movement registration will be used to determine the biomechanical balance control strategy across the lifespan during unperturbed and perturbed standing. The innovative but focused scope of this study could provide a breakthrough in our biomechanical understanding of balance control and, in particular, the changes in limitations of balance control in childhood and an ageing (fall-prone) population. The gained fundamental knowledge could lead to unprecedented insights in the causes of falling across the lifespan and in possible targets for intervention.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Hasselt, 벨기에, 3500
- Hasselt University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- prepubertal children (6-9y)
- postpubertal children (15-18y)
- young adults (18-24y)
- healthy non-falling older adults (65-80y) will be included if they 1) did not experience two or more falls during normal daily activities in the preceding year and 2) have no cognitive impairment (tested with Mini-Mental state examination).
Exclusion Criteria:
- inability to speak and understand Dutch;
- inability to maintain independent unsupported stance for 60 seconds;
- current diagnosis of neurological or sensory disorders;
- recurrent dizziness;
- obesity ;
- a history of orthopaedic disorders;
- surgical operation of the lower extremity during last two years;
- use of drugs affecting the CNS or known to affect balance control.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Age group 1
6-9 years old
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The unstable surface will be created with a balance board consisting of a wooden board mounted on a section of a cylinder, creating an unstable support in the sagittal plane or in the frontal plane.
The participants will stand on three balance boards, varying the height of the surface of the board above the point of contact (15, 17 and 19 cm respectively).
The radius of the cylinder will kept constant at 24 cm.
The standing surface will be 48cm x 48 cm
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실험적: Age group 2
15-17 years old
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The unstable surface will be created with a balance board consisting of a wooden board mounted on a section of a cylinder, creating an unstable support in the sagittal plane or in the frontal plane.
The participants will stand on three balance boards, varying the height of the surface of the board above the point of contact (15, 17 and 19 cm respectively).
The radius of the cylinder will kept constant at 24 cm.
The standing surface will be 48cm x 48 cm
|
실험적: Age group 3
18 - 24 years old
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The unstable surface will be created with a balance board consisting of a wooden board mounted on a section of a cylinder, creating an unstable support in the sagittal plane or in the frontal plane.
The participants will stand on three balance boards, varying the height of the surface of the board above the point of contact (15, 17 and 19 cm respectively).
The radius of the cylinder will kept constant at 24 cm.
The standing surface will be 48cm x 48 cm
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실험적: Age group 4
65-80 years old
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The unstable surface will be created with a balance board consisting of a wooden board mounted on a section of a cylinder, creating an unstable support in the sagittal plane or in the frontal plane.
The participants will stand on three balance boards, varying the height of the surface of the board above the point of contact (15, 17 and 19 cm respectively).
The radius of the cylinder will kept constant at 24 cm.
The standing surface will be 48cm x 48 cm
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Balance Control; centre of mass acceleration based on 3D movement registration and ground reaction forces
기간: day 1
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Centre of mass acceleration (in kg.m2/s2) (calculations based on; van Dieen JH, van Leeuwen M, Faber GS.
Learning to balance on one leg: motor strategy and sensory weighting.
J Neurophysiol.
2015;114(5):2967-82.)
|
day 1
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Contribution of the ankle strategy to centre of mass acceleration based on 3D movement registration and ground reaction forces
기간: day 1
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The contribution of the ankle strategy (difference between the centre of pressure and the centre of mass (in kg.m2/s2)) to centre of mass acceleration in the sagittal and frontal plane will be calculated based on total body kinematics (SIMI motion - 3D movement registration) and kinetics (AMTI force plate) (calculations based on; van Dieen JH, van Leeuwen M, Faber GS.
Learning to balance on one leg: motor strategy and sensory weighting.
J Neurophysiol.
2015;114(5):2967-82.)
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day 1
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Contribution of the counter-rotation mechanism to centre of mass acceleration based on 3D movement registration and ground reaction forces
기간: day 1
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The contribution of the counter-rotation mechanism (change in angular momentum (in kg.m2/s2)) to centre of mass acceleration in the sagittal and frontal plane will be calculated based on total body kinematics (SIMI motion - 3D movement registration) and kinetics (AMTI force plate) (calculations based on; van Dieen JH, van Leeuwen M, Faber GS.
Learning to balance on one leg: motor strategy and sensory weighting.
J Neurophysiol.
2015;114(5):2967-82.))
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day 1
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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 연구와 관련된 용어
기타 연구 ID 번호
- Projectlifespanbalance2018-001
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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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