Turning Dysfunction After Stroke: Assessment and Intervention
2020년 12월 13일 업데이트: Pei Jung Liang, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Turning Dysfunction After Stroke And Its Association To Trunk Control: Underlying Mechanisms And Training Effects
The study aims to investigate the 1) differences between stroke patients and healthy controls in time, steps, angular velocity, stepping patterns, electromyographic responses during turning, and the association of turning to trunk control and motor function after stroke; 2) the effectiveness of trunk training on turning performance, trunk control and motor function in stroke patients.
연구 개요
상세 설명
This study has two parts.
The first part is a cross-sectional observatory study.Eligible stroke and healthy subjects are asked their demographic data and assessed for turning performance (stepping patterns and electromyography data of trunk muscles), trunk control (muscle strength, active range of motion, muscle mass and motor control in trunk) and motor function (recovery of extremities and balance function).
The second part is a randomized controlled trial.
Stroke participants are randomly allocated into trunk exercise and control groups.
Trunk exercise group receives trunk exercise including trunk muscles stretching, trunk muscles strengthening, and task-related trunk control training for 30 minutes per session, twice a week for 12 weeks while control group remains their regular activities.
Turning performance, trunk control and motor function are evaluated before and after training session.
연구 유형
중재적
등록 (실제)
42
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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New Taipei City, 대만
- Taipei Tzu Chi Hospital
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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
20년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- age between 20 and 80 years old
- survivors of a single and unilateral stroke with hemiparesis experienced at least 6 months prior to their participation in the study
- able to walk independently over a distance of 10 m without walking aids or orthoses
- able to provide informed consent and follow instructions.
Exclusion Criteria:
- having additional musculoskeletal conditions or comorbid disabilities that could affect the assessment
- having cognitive problems with a Mini-Mental State Examination score less than 24 or aphasia that could prevent subjects from following instructions.
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 |
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실험적: Trunk exercise group
Participants received trunk exercise for 30 minutes per session, twice a week for 12 weeks.
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Trunk exercise includes trunk muscles stretching, trunk muscles strengthening, and task-related trunk control training for 30 minutes per session, twice a week for 12 weeks.
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간섭 없음: Control group
Participants remained their regular activities.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change from Baseline in turning duration at Week 12
기간: Baseline and Week 12
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Turning duration (s) was recorded during turning 360-degree in place using APDM Opal wireless sensors.
Longer duration represents poorer turning performance.
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Baseline and Week 12
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Change from Baseline in turning angular velocity at Week 12
기간: Baseline and Week 12
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Angular velocity (m/s2) was recorded during turning 360-degree in place using APDM Opal wireless sensors.
Slower angular velocity represents instability during turning.
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Baseline and Week 12
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Change from Baseline in trunk muscles electromyography during turning at Week 12
기간: Baseline and Week 12
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Muscle activation patterns (amplitude, % reference voluntary contraction) are observed in bilateral External abdominal oblique (EO) and erector spinae (ES) through an electromyographic analysis.
Greater muscle amplitude represents greater muscle contraction.
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Baseline and Week 12
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change from Baseline in trunk range of motion at Week 12
기간: Baseline and Week 12
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The trunk range of motion (ROM) was measured using a tape measure in sitting position.
The spinous processes at C7 and S1 served as landmarks for placement of the tape and measurement for trunk flexion and extension ROM.
The length between iliac crest and contralateral acromion of scapula was measured for trunk rotation ROM while the distance between the tip of the middle finger and the floor for trunk lateral flexion ROM.
The difference between tape measures in starting and ending positions was calculated for all trunk movement directions.
Greater value of trunk flexion and rotation but smaller value of trunk extension and lateral flexion represents better trunk ROM.
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Baseline and Week 12
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Change from Baseline in trunk muscles strength at Week 12
기간: Baseline and Week 12
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Trunk flexors, extensors, rotators, and lateral flexors strength were measured using a MicroFET3 dynamometer.
Participants were asked to generate the maximum trunk flexion, extension, rotation bilaterally and lateral flexion bilaterally for a period of 6 seconds each.
Resistance was applied using the dynamometer to obtain the value of each trunk muscle (kg).
Greater value represents greater muscle strength.
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Baseline and Week 12
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Change from Baseline in Trunk Impairment Scale at Week 12
기간: Baseline and Week 12
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Trunk control was assessed by the Trunk Impairment Scale (TIS) which has good inter-rater reliability with intra-class coefficient 0.85-0.99 and internal consistency with Cronbach's α 0.65-0.89.
The TIS evaluates static and dynamic sitting balance and trunk coordination in a sitting position.
On the static and dynamic sitting balance and coordination subscales the maximal scores that can be attained are 7, 10 and 6 points.
The total score for TIS ranges between 0 for a minimal performance to 23 for a perfect performance.
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Baseline and Week 12
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change from Baseline in Modified Clinical Test of Sensory Integration and Balance at Week 12
기간: Baseline and Week 12
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Modified Clinical Test of Sensory Integration and Balance (mCTSIB) is designed to assess how well an older adult is using sensory inputs when one or more sensory systems are compromised.
The postural sway was measured in 4 sensory conditions through visual and proprioceptive manipulation using APDM Opal wireless sensors.
The greater postural sway represents the poorer balance.
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Baseline and Week 12
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Change from Baseline in Berg Balance Scale at Week 12
기간: Baseline and Week 12
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The Berg balance scale (BBS) is used to objectively determine a participant's ability to safely balance during a series of predetermined tasks.
It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.
The total score is 56.
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Baseline and Week 12
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Change from Baseline in Timed Up and Go test at Week 12
기간: Baseline and Week 12
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Function mobility was assessed by the Timed Up and Go (TUG) test.
Participants were instructed to stand up from a chair, walk 3 meters, turn around, and walk back to the chair sit down.
Time to complete the task was recorded.
The more time taken is representative of the lower level of functional mobility.
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Baseline and Week 12
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Pei-Jung Liang, Taichung Tzu Chi Hospital
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)
2020년 7월 13일
기본 완료 (실제)
2020년 10월 31일
연구 완료 (실제)
2020년 10월 31일
연구 등록 날짜
최초 제출
2020년 12월 8일
QC 기준을 충족하는 최초 제출
2020년 12월 13일
처음 게시됨 (실제)
2020년 12월 16일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 12월 16일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 12월 13일
마지막으로 확인됨
2020년 12월 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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