- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05127993
Comprehensive Evaluation of the Passive Talaris Demonstrator
연구 개요
상세 설명
Twenty-eight healthy active participants with an unilateral transtibial amputation will conduct 2 experimental trials (EXP1 & EXP2) on the same day in a randomized order, i.e. EXP1 with the currently used prosthesis and EXP2 with the passive Talaris Demonstrator. Each experimental trial will include 6 minutes of treadmill walking at 3 different speeds in consecutive blocks of 2 minutes, a slope walking test, a stair climbing test, a L-test and an outdoor walking task.
The six minutes walk test (6MWT) has become one of the most widely used performance-based outcome measures of functional mobility and exercise capacity. Recently, the 6MWT has been found to correlate with single-limb balance time and symmetry of step length in people with amputation. Additionally, the 6MWT distance has been shown to be responsive to functional training interventions in people with lower-limb amputation. Six minutes of treadmill walking at 3 different speeds will be performed. This test will be performed in consecutive blocks of 2 minutes. These consecutive blocks will be walking 2 minutes at self-selected (SS) speed, 2 minutes at 75% of the SS speed and 2 minutes at 125% of the SS speed. These different walking speeds elicit different angular positions of the ankle and activation levels of muscles, and thus might alter the effectiveness of the novel device.
The slope walking test assesses the participants' ability to ascend and descend a 6 m long ramp of 10% inclination as fast as possible. For safety reasons bilateral handrails are warranted. Participants start the test in an upright position in front of the ramp and are asked to ascend the ramp, turn around on the platform, descend the ramp and return to the starting position.
The stair climbing test assesses the participants' ability to ascend and descend a staircase (84 cm total height, 3-step staircase with an average rise of 28 cm and run of 18 cm). Participants start in front of the staircase and are asked to ascend and descend as fast as possible. Again, bilateral handrails are required to allow support when needed. The ascending phase is initiated with the prosthetic side, while the first step of the descending phase is performed with the non-involved leg.
The L-test, requires higher physical activity of the user. During the L-test, participants are asked to rise from a chair, walk 7 meters, turn 90 degrees, walk 3 meters, turn 180 degrees and then return in the same way to the seated position. A total distance of 20 meter is covered.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Brussels, 벨기에, 1050
- Vrije Universiteit Brussel
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Unilateral transtibial (below knee) amputation
- Unilateral transfemoral (above knee) amputation
- Healthy subject
- Medicare Functional Classification Level: K2-4
Exclusion Criteria:
- Any neurological disease
- Upper limb or bilateral amputation
- Stump pain or bad fit of the socket
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Novel prosthesis
A unilateral transtibial amputee will conduct experiments with the novel prosthesis followed by experiments with the current prosthesis.
|
The amputee will walk with the passive Talaris Demonstrator, a novel prosthetic foot, designed and built by "Axiles Bionics".
|
활성 비교기: Current prosthesis
A unilateral transtibial amputee will conduct experiments with the current prosthesis followed by experiments with the novel prosthesis.
|
The amputee will walk with the passive Talaris Demonstrator, a novel prosthetic foot, designed and built by "Axiles Bionics".
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Performance
기간: Through study completion, a period of 4 months
|
Heart rate during all tasks
|
Through study completion, a period of 4 months
|
Performance
기간: Through study completion, a period of 4 months
|
Time needed to perform the L-test
|
Through study completion, a period of 4 months
|
Performance
기간: Through study completion, a period of 4 months
|
Speed during 6 minutes walk test
|
Through study completion, a period of 4 months
|
Physiological
기간: Through study completion, a period of 4 months
|
Electromyography: lower limb muscle activity during different movements (% of the MVC)
|
Through study completion, a period of 4 months
|
Physiological
기간: Through study completion, a period of 4 months
|
Oxygen consumption during stair climbing, slope walking and during the 6 minutes walk test
|
Through study completion, a period of 4 months
|
Psychological
기간: Through study completion, a period of 4 months
|
Visual analogue scale for comfort (score: 0= not comfortable, 100 = comfortable) and fatigue (score: 0= not fatiguing, 100 = fatiguing) during all tasks
|
Through study completion, a period of 4 months
|
Biomechanical
기간: Through study completion, a period of 4 months
|
Joint angels and joint angular velocities of hip, knee and ankle joints
|
Through study completion, a period of 4 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Kevin De Pauw, Vrije Universiteit Brussel
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
- BUN143201526629
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. .
Passive Talaris Demonstrator에 대한 임상 시험
-
University of ExtremaduraUniversity of Cadiz완전한Radiculopathy, Lumbosacral 영역