- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04054739
Cortical Activity and Gait Function for Robotic Gait Training in Hemiparetic Stroke
2020년 2월 9일 업데이트: Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea
Effects of Robotic Gait Training on Cortical Activity and Gait Function in Hemiparetic Stroke
Effects of robot-assisted gait training on cortical activity and gait function in hemiparetic stroke
연구 개요
연구 유형
중재적
등록 (실제)
30
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
-
Seoul, 대한민국, 142884
- National Rehabilitation Center
-
-
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
19년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Hemiplegic patients secondary to first cerebrovascular accidents
- Functional ambulation category score 3
- 3 months ≤ Onset ≤ 12 months
- Korean Mini-Mental State Examination score > 24
Exclusion Criteria:
- History of surgery of affected lower limb
- Fracture of affected lower limb
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: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Robot-assisted gait training
experimental group that applied the end-effector robot-assisted gait training
|
intervention with robot-assisted gait training
|
|
활성 비교기: Treadmill gait training
control group that applied the treadmill gait training
|
intervention with treadmill gait training
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
oxygenated hemoglobin levels
기간: 4 weeks from baseline
|
cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait
|
4 weeks from baseline
|
|
Range of motion of ankle, knee, and hip joint
기간: 4 weeks from baseline
|
ankle, knee, and hip joint motion of sagittal plane during gait
|
4 weeks from baseline
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
oxygenated hemoglobin levels
기간: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
|
Range of motion of ankle, knee, and hip joint
기간: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
ankle, knee, and hip joint motion of sagittal plane during gait
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
|
Berg Balance Scale
기간: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
Berg Balance Scale assess the functional balance ability of participants with observation of 14 tasks, representing functional movements common in daily life.
Each task is scored on a five-point scale (0-4) following the guidelines of the test developers, and the maximum score on this test is 56 which indicates balance ability within the normal range.
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
|
Fugl-Meyer Assessment
기간: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
Fugl-Meyer Assessment uses to examine the motor function and coordination of affected lower extremity.
It includes 17 items of a 3-point ordinal scale, ranging 0-34, with higher scores indicating lower impairment.
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
|
10m walk test
기간: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
10m walk test is used to examine gait speed, in which participant was asked to walk on a 14 meter of walkway wearing harness with two conditions; with the fastest speed or with self-selected comfortable speed.
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
|
Functional ambulation category
기간: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
Functional Ambulation Category is used to assess gait ability with 6 levels ranging from 0 to 5 on the basis of the amount of physical support required, regardless of use of an assistive device
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
|
Falls efficacy scale
기간: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
Korean version of Falls efficacy scale asks subjects to rank their confidence about their ability not to fall while performing a variety of activities of daily living with a maximum score of 100
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
|
Beck depression inventory
기간: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
21-question multiple-choice self-report inventory, one of the most widely used psychometric tests
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
|
Stroke impact scale
기간: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
health-related quality of life poststroke across 8 domains using a 5-point Likert scale, with the score ranging from 0 to 100 and a higher score indicating better health status
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
|
Dynamic gait index
기간: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
a clinical tool to assess gait, balance and fall risk
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
|
Timed up and go test
기간: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
a simple test used to assess a person's mobility and requires both static and dynamic balance
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
|
modified Barthel index
기간: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
Measure of physical disability used widely to assess behaviour relating to activities of daily living for stroke patients
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
|
dual task - COWAT
기간: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
Controlled Oral Word Association Test, abbreviated COWA or COWAT, is a verbal fluency test that measures spontaneous production of words belonging to the same category or beginning with some designated letter.
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
|
dual task - digit span test
기간: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
The digit span test is a way of measuring the storage capacity of a person's working memory.
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
|
Electromyography of lower extremities
기간: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
Muscle activity of tibialis anterior, medial gastrocnemius, vastus medialis, biceps femoris, gluteus medius during gait.
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
|
Plantar pressure
기간: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
Plantar pressure (great toe, little toe, medial meta, lateral meta, medial arch, lateral arch, heel) during gait
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
|
Spatiotemporal gait parameter data
기간: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
step length, step time, swing time, double limb support time during gait
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
|
deoxygenated hemoglobin levels
기간: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
|
total hemoglobin levels
기간: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
|
Balance test using force plate
기간: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
Static standing balance as measured using a force plate: Changes in center-of-pressure velocity and area
|
baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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 (실제)
2018년 9월 1일
기본 완료 (실제)
2019년 11월 30일
연구 완료 (실제)
2019년 12월 31일
연구 등록 날짜
최초 제출
2019년 8월 12일
QC 기준을 충족하는 최초 제출
2019년 8월 12일
처음 게시됨 (실제)
2019년 8월 13일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 2월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 2월 9일
마지막으로 확인됨
2020년 2월 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. .