Discrete Versus Rhythmic Gait Training
2017년 5월 2일 업데이트: Thais Amanda Rodrigues
Robot-assisted Locomotor Training After Severe Stroke: Discrete Versus Rhythmic Movement
The objective of this study is to compare the effects of novel versus standard locomotor training using a robotic gait orthosis (LT-RGO) after stroke.
The hypothesis is that the novel LT-RGO protocol, by establishing a progressive decrease in gait velocity and guidance force, may facilitate greater motor recovery compared to the use of a standard protocol.
연구 개요
상세 설명
Standard (rhythmic) robot-assisted locomotor training on a bodyweight-supported treadmill (LT-BWST) used progressively increased speed each week.
Novel (discrete) robot-assisted LT-BWST used progressive decrease in speed.
The novel approach of slowing down the treadmill reduced momentum.
If speed had been increased (standard approach), momentum would have increased (momentum = mass * velocity); and the resulting, passive propulsion of momentum would have diminished the role of cortical skills needed to plan, initiate, and overtly control gait.
In sum, the novel protocol used a slower-than-standard treadmill speed in order to provide a window of time sufficient for the corticomotor system to process information, learn, and adjust its response to internal and external feedback (eg, proprioceptive input; therapist input) during robot-assisted LT-BWST.
연구 유형
중재적
등록 (실제)
20
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Sao Paulo, 브라질, 05716-150
- Instituto de Medicina Física e Reabilitação - Lucy Montoro
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Clinical diagnosis of stroke and image with hemiparesis left or right;
- No more that one ischemic or hemorrhagic stroke episode;
- 06 months post-stroke;
- Verified clinical stability on medical evaluation;
- Spasticity level I or II in the Ashworth scale;
- Score 1-2 in the Functional Ambulation Scale (FAC);
- Signed informed consent.
Exclusion Criteria:
- Dependence to perform activities of daily living before the stroke;
- Lack of clinical indications for exercises (such as cardiopulmonary instability and uncontrolled diabetes);
- Severe cognitive impairment;
- Serious psychiatric change that needs psychiatric care;
- Severe osteoporosis;
- Severe spasticity of the lower limbs, deformities or fixed contractures that prevent the achievement of movements;
- Lack of resistance or disabling fatigue;
- Body weight greater than 150 kg;
- Unstable angina or other untreated heart disease;
- Chronic obstructive pulmonary disease;
- Unconsolidated fractures, pressure sores;
- Other neurological diseases.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Novel Protocol
Progressive decrease of speed and guidance force on robotic gait training.
Initial speed is 1.4 km/h and final speed is 1.0 km/h.
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All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup).
Novel (discrete) robot-assisted LT-BWST used progressive decrease in speed.
Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h.
The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week.
The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject.
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실험적: Standard Protocol
Progressive increase of speed and decrease of guidance force on robotic gait training.
Initial speed is 1.4 km/h and final speed is 1.9 km/h.
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All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup).
Standard (rhythmic) robot-assisted LT-BWST used progressively increased speed each week.
Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h.
The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week.
The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Functional Ambulation Scale (FAC)
기간: Baseline and 6 weeks
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The Functional Ambulation Scale (FAC) assesses an individual's independence during gait and follows a six-level scale: 0 - Patient can not walk or ask for help from two or more people; 1 - Patient requires continuous support from a person who assists with weight and balance; 2 - Patient needs continuous or intermittent support from a person to help with balance and coordination; 3 - Patient required for a person without physical contact; 4 - Patient can walk independently on the floor, but requires help on stairs and ramps; 5 - Patient can walk independently. This study compared the gait independence by the FAC between the two Arms, after intervention as compared to baseline. |
Baseline and 6 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Six-minute Walking Test (6MWT)
기간: Baseline and 6 weeks
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Change in distance of the gait applied test after intervention as compared to baseline
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Baseline and 6 weeks
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Time Up and Go (TUG)
기간: Baseline and 6 weeks
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This test assesses the level of mobility of the individual to measure the time spent to get up from a chair, walk a distance of 3 meters, turn around and return.
This study compared the change in the time of the gait applied test after intervention as compared to baseline.
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Baseline and 6 weeks
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Ten-meters Walking Test (10MWT)
기간: Baseline and 6 weeks
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Change in the time of the gait applied test after intervention as compared to baseline
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Baseline and 6 weeks
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Lower Limbs Fugl-Meyer
기간: Baseline and 6 weeks
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The Fugl Meyer Scale is a cumulative numerical scoring system that is assessed by an individual: range of motion, pain, tenderness, upper and lower extremity motor function and balance, plus coordination and speed of movement, with total 226 points. A three-point ordinal scale is applied to each item: 0 - can not be performed, 1-performed partially and 2-performed completely. For this study it was only an evaluation of motor function of the extremity of lower limbs with a total score of 0 to 34 points. The lower score indicates greater motor impairment. This study compared the change in motor function of lower limbs applied scale after intervention as compared to baseline |
Baseline and 6 weeks
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Berg Scale
기간: Baseline and 6 weeks
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Berg Scale is a functional scale of equilibrium performance, based on 14 common everyday items that evaluate the static and dynamic balance.
The maximum scale score is 56 and each scale item has five alternatives ranging from 0 to 4 points.
A score below 45 is considered a fall risk.
This study comparede the change in the balance control applied scale after intervention as compared to baseline.
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Baseline and 6 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: Daniel G Goroso, Doctor, University of Sao Paulo
- 연구 의자: Lumy Sawaki, PhD, University of Kentucky
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2014년 11월 1일
기본 완료 (실제)
2016년 3월 1일
연구 완료 (실제)
2016년 9월 1일
연구 등록 날짜
최초 제출
2016년 1월 5일
QC 기준을 충족하는 최초 제출
2016년 1월 6일
처음 게시됨 (추정)
2016년 1월 8일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 9월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 5월 2일
마지막으로 확인됨
2017년 5월 1일
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. .
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Institut National de la Santé Et de la Recherche...모병
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