- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04637737
Effect of Anterioposterior Weight Shifting Training With Visual Biofeedback in Subacute Stroke
Asymmetric gait patterns of stroke is one of the most important functional activities to enable community participation, it is major goal for stroke patients. Reported that the stroke patients had asymmetry at stance time, single stance, double support time, and swing time compared to normal people, and claimed that the most important factor was step length. According to Albert et al., patients with an asymmetric gait pattern have a long double support phase and a healthy side single support phase, and less weight shift to the affected side. Recent studies have shown that visual feedback for weight shift may be helpful to obtain a symmetrical posture after stroke. However, no study has been conducted on the therapeutic effect on gait asymmetry and patterns. We aimed to investigate the effect of Anterioposterior Weight Shifting Training with Visual Biofeedback in subacute post-stroke patients on gait asymmetry and pattern.
40 subacute post-stroke patients with Step Length Asymmetry were enrolled in this study. The subjects were randomly assigned into two groups. The training group received an additional anterioposterior weight shifting training with visual Biofeedback 5 times per week for 4weeks. The control group received the usual gait training. The spatiotemporal and kinematic data were obtained during walking through 3D motion analysis. Functional Ambulation Category, Self-selected walking speed, Maximum safe walking speed, Berg balance Test (BBT), Fugl-Meyer Assessment (FMA), Medical Research Council Score (MRC), Functional Independent Measure-mobility, Timed Up and Go test (TUG) were assessed at pre, during, post- training, and 4week follow-up. Those were compared between two groups by repeated measures ANOVA.
연구 개요
상태
정황
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Seoul, 대한민국
- 모병
- Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine
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연락하다:
- Deog Young Kim
- 전화번호: +82-2-2228-3714
- 이메일: KIMDY@yuhs.ac
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- less than 6 months after onset of the stroke
- can stand and walk independently 10m
- K-MMSE score of at least 15
- have asymmetrical gait pattern with Step length asymmetric ratio greater than 1.1
- over 20 years of age.
Exclusion Criteria:
- quadriplegia
- past history of stroke
- past history of Musculoskeletal disease or history of Neurological diseases
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: 대조군
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The control group received the usual gait training.
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실험적: 교육 그룹
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The training group received an additional anterioposterior weight shifting training with visual Biofeedback 5 times per week for 4weeks. AP training is made to instantly know your training status during training by measuring and processing the foot pressure in real time using the F-Scan (Tekscan) hardware system and Software Development Kit (SDK). Before training, all patients are instructed to place both feet at shoulder width, place the inverted foot approximately 30 cm in front of the unaffected side foot, move the body forward with the chest straight in an upright position, and be instructed to put the weight on the affected side. On the screen shown, measure the maximum weight distribution during the first 10 times and set the value added by 5% as the target value. It is designed to induce the maximum weight shift through the archery game. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Step Length Asymmetric Ratio
기간: before training(0week)
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Step Length Asymmetric Ratio = paretic step length/non paretic step length
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before training(0week)
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Step Length Asymmetric Ratio
기간: during training(2week)
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Step Length Asymmetric Ratio = paretic step length/non paretic step length
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during training(2week)
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Step Length Asymmetric Ratio
기간: after training(4week)
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Step Length Asymmetric Ratio = paretic step length/non paretic step length
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after training(4week)
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Step Length Asymmetric Ratio
기간: Follow up(8week)
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Step Length Asymmetric Ratio = paretic step length/non paretic step length
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Follow up(8week)
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Step Length Asymmetric Index
기간: before training(0week)
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Step Length Asymmetric Index = paretic step length-non paretic step length/0.5[paretic
step length +non paretic step length]
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before training(0week)
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Step Length Asymmetric Index
기간: during training(2week)
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Step Length Asymmetric Index = paretic step length-non paretic step length/0.5[paretic
step length +non paretic step length]
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during training(2week)
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Step Length Asymmetric Index
기간: after training(4week)
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Step Length Asymmetric Index = paretic step length-non paretic step length/0.5[paretic
step length +non paretic step length]
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after training(4week)
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Step Length Asymmetric Index
기간: Follow up(8week)
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Step Length Asymmetric Index = paretic step length-non paretic step length/0.5[paretic
step length +non paretic step length]
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Follow up(8week)
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
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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. .