- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04325516
Decoding Motion Planning Using Cortical Potentials
Decoding Motion Planning Using Cortical Potentials in People With a Transfemoral Amputation and Able-bodied Individuals
연구 개요
상세 설명
The evolution of lower limb prostheses has made considerable progress in the past decades. There has been a transition from passive (e.g. Total knee®, Össur) to quasi-passive (e.g. C-leg®, Otto Bock) and eventually to active prostheses (e.g. Power knee®, Össur). The development always focused on an amputation as a primary peripheral disorder. For example, manufacturers have been searching to compensate the loss of muscle mass by adding torque into the prosthesis. However, few considerations have yet been taken to the fact that central adaptations are also observed after amputation in terms of neuroplasticity and reorganization.
The atypical motion planning strategies of people with a lower limb amputation (LLA) could possibly be related to the challenges that they experience during daily activities, such as the sit to stand transfer. Standing up from a chair is a relevant clinical problem and current devices do not yet relieve the asymmetrical loading. A few studies have already investigated the muscular activity during a sit to stand movement in people with a LLA and able-bodied individuals. The movement is characterized by a forward displacement of the centre of mass with the highest activation of the m. gluteus maximus, m. adductor magnus and m. biceps femoris.The sit to stand transfer is a potential movement to investigate brain activity incorporating the advantages and disadvantages of EEG measurements.
Until now, the development of lower limb prostheses approaches people with a LLA as a peripheral disorder whereas relevant central adaptations are also observed. Therefore, the purpose of this study is to identify the cortical activity that is responsible for successfully completing a sit to stand transfer. The hypothesis is that different brain locations are activated in people with a transfemoral amputation for motion planning compared to able-bodied individuals.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Brussel, 벨기에, 1050
- 모병
- Vrije Universiteit Brussel
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연락하다:
- Jo Ghillebert, msc
- 전화번호: 0494902770
- 이메일: jo.ghillebert@vub.be
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age: 25 - 75 years
- Gender: men and women
- Level of amputation: unilateral transfemoral
- Vascular or traumatic cause of amputation
- Medicare Functional Classification Level25: K3-4
- Participants are able to stand up from a chair and return to the seated position without support of their hands for ten repetitions
- Participants wear their prosthesis for at least 8 hours/day (Prosthetic use has been shown to have an influence on functional reorganization)
- No cognitive impairment. This will be objectified with the mini-mental state examination (score on 30)
Exclusion Criteria:
- Any neurological disease
- No upper limb or bilateral amputation
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: People with a lower limb amputation
Participants will perform four tasks in a randomized order:
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Participants will perform four tasks in a randomized order:
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실험적: Able bodied individuals
Participants will perform four tasks in a randomized order:
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Participants will perform four tasks in a randomized order:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
ElectroEncephalography in milliseconds
기간: Approximatley 9 months
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Movement related cortical potential before the actual movement
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Approximatley 9 months
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ElectroMyography activity in milliseconds
기간: Approximatley 9 months
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Amplitude
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Approximatley 9 months
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ElectroMyography timing
기간: Approximatley 9 months
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Time of movement onset
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Approximatley 9 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Duration of the sit to stand test
기간: Approximatley 9 months
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Duration of the sit to stand test
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Approximatley 9 months
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
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
- EEGstudy
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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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