Effects of RR and MT on Patient With Stroke
2012년 7월 29일 업데이트: National Taiwan University Hospital
Randomized Trials of Robotic Rehabilitation, Mirror Therapy, and Dose-Matched Control Intervention for Upper-Limb Rehabilitation in Patients With Chronic Stroke: Comparative Efficacy and Clinimetric Study
The purpose of this proposal is 1) to compare the relative effects of the robotic rehabilitation (RR), mirror therapy (MT), and conventional intervention (CI), 2) to compare the effects of the combined therapy of the RR-Functional Electrical Stimulation (FES) and the RR-Placebo Intervention (PI), and 3) to identify the clinical predictors that will potentially influence the functional outcomes after interventions.
연구 개요
상태
알려지지 않은
정황
상세 설명
Motor deficit of upper extremity is one of the prominent problems in patients with stroke.
Looking for effective and efficient treatments to improve affected UE function is of great importance in the field of rehabilitation.
Two emerging movement therapies in stroke rehabilitation are robotic rehabilitation (RR) and mirror therapy (MT).
Scientific evidence for comparative effectiveness research of RR versus MT versus CI on functional outcomes (e.g., motor, muscle, sensory, and daily functions) in stroke patients is limited.
In addition, studies showed FES induced some improvements in individual movements at the shoulder, elbow, wrist, and fingers or in muscle strength in patients with moderate-to-severe paresis.
The combination therapy of the FES and training protocols may increase the benefits of standard rehabilitative treatments and may also facilitate motor learning.
However, the combined training effects of the RR and FES on stroke patients have not been well studies in a larger sample yet.
Specific objectives of this proposed research are as follows: First, The investigators will compare the efficacy of the RR, MT, and conventional rehabilitation.
Secondly, the investigators will compare the efficacy of the RR-FES versus RR-PI on outcome measures.
Thirdly, the investigators will identify the clinical predictors that will potentially influence the functional outcomes after interventions.
연구 유형
중재적
등록 (예상)
100
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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Taipei City, 대만
- 모병
- National Taiwan University Hospital
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연락하다:
- Keh-chung Lin, ScD
- 전화번호: 886-2-33668180
- 이메일: kehchunglin@ntu.edu.tw
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수석 연구원:
- Keh-chung Lin, ScD
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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
40년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Willing to provide the written informed consent
- More than 6 months onset of unilateral stroke
- An initial 25-56 or 18-50 scores on the UE subtest of the FMA
- Sufficient cognitive ability (Mini Mental State Examination ≧ 24 points)
- Without upper limb fracture within 3 months
Exclusion Criteria:
- Recurrent of stroke or seizure episode during the intervention
- Occurence of serious or continuous pain on affected upper-extremity
- History of other neurological disease or severe orthopaedic condition
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: 요인 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Robotic Rehabilitation with FES
Robotic rehabilitation combined Functional Electrical Stimulation (FES)
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이 결합된 RR-FES 치료는 환자가 RR과 동시에 FES를 받는 것을 제외하고는 RR 요법과 동일한 프로토콜을 포함합니다.
다른 이름들:
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실험적: Mirror Therapy
Mirror Therapy (MT)
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이 프로토콜에는 세션당 1시간의 거울 요법과 0.5시간의 기능 훈련이 포함됩니다.
치료강도는 1.5시간/일, 5일/주, 4주간이다.
MT는 대칭적인 양손 움직임에 초점을 맞추고 동시에 영향을 받지 않은 상지에서 반사되는 거울 시각적 피드백을 관찰합니다.
다른 이름들:
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활성 비교기: Conventional Rehabilitation
Conventional Rehabilitation (CR) mainly focuses on occupational therapy training
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이 그룹의 참가자는 신경 발달 기술 및 작업 중심 접근 방식과 같은 작업 치료를 기반으로 하는 구조화된 프로토콜을 받습니다.
치료 용량은 RR 및 MT 그룹과 일치합니다.
다른 이름들:
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실험적: Robotic Rehabilitation
Robotic Rehabilitation (RR)
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This protocol includes 5 to 10 min of warm-up, 1 hr of RR, and 15 to 20 min of functional activities training.
The treatment intensity is 1.5 hours/day, 5days/week for 4 consecutive weeks.
The RR session uses the robot-assisted arm trainer, Bi-Manu-Track (Reha-Stim Co., Berlin, Germany).
다른 이름들:
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위약 비교기: Robotic Rehabilitation with PI
Robotic rehabilitation with Placebo Intervention (RR-PI)
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The RR-PI protocol is the same as the RR-FES protocol described above except that the surface electrodes are attached to the same target muscles on the affected UL but there is no output of electrical stimulation.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Fugl-Meyer Assessment (FMA)
기간: Change from baseline in FMA at 4 weeks, change from baseline in FMA at 8 weeks, change from baseline in FMA at 16 weeks, change from baseline in FMA at 28 weeks
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The upper-extremity subscale of the FMA contains 33 items to assess motor impairment.
Each item is scored on a 3-point ordinal scale (0-cannot perform, 1-performs partially, 2-performs fully and correctly).
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Change from baseline in FMA at 4 weeks, change from baseline in FMA at 8 weeks, change from baseline in FMA at 16 weeks, change from baseline in FMA at 28 weeks
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Modified Ashworth Scale (MAS)
기간: Change from baseline in MAS at 4 weeks, change from baseline in MAS at 8 weeks, change from baseline in MAS at 16 weeks, change from baseline in MAS at 28 weeks
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The MAS is a 5-point ordinal scale to evaluate muscle tone of upper-extremity.
Higher score indicates a more severe hypertonia.
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Change from baseline in MAS at 4 weeks, change from baseline in MAS at 8 weeks, change from baseline in MAS at 16 weeks, change from baseline in MAS at 28 weeks
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Functional independence measure (FIM)
기간: Change from baseline in FIM at 4 weeks, change from baseline in FIM at 8 weeks, change from baseline in FIM at 16 weeks, change from baseline in FIM at 28 weeks
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The FIM consists of 18 items grouped into 6 subscales measuring self-care, sphincter control, transfer, locomotion, communication, and social cognition ability.
Each item is rated from 1 to 7 based on the required level of assistance to perform the tasks.
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Change from baseline in FIM at 4 weeks, change from baseline in FIM at 8 weeks, change from baseline in FIM at 16 weeks, change from baseline in FIM at 28 weeks
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Movement units (MU)
기간: Change from baseline in MU at 4 weeks
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The parameter of movement units is collected by a 7-camera motion analysis system (VICON MX 3-D, Oxford Metrics Inc., Oxford, UK) from unilateral and bilateral reaching tasks of pressing the desk bell.
One acceleration phase and one deceleration phase constitute a MU.
The number of MU indicates the movement smoothness.
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Change from baseline in MU at 4 weeks
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Total displacement (TD)
기간: Change from baseline in TD at 4 weeks
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The TD is collected by a 7-camera motion analysis system (VICON MX 3-D, Oxford Metrics Inc., Oxford, UK) from unilateral and bilateral reaching tasks of pressing the desk bell.
TD refers to the path of a hand shifting in three-dimensional space and is a measurement of trajectory smoothness.
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Change from baseline in TD at 4 weeks
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Percentage of peak velocity (PPV)
기간: Change from baseline in PPV at 4 weeks
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PPV is collected by a 7-camera motion analysis system (VICON MX 3-D, Oxford Metrics Inc., Oxford, UK) from unilateral and bilateral reaching tasks of pressing the desk bell.
PPV indicates the percentage of acceleration phase among the whole movement process.
It is an outcome measurement of pre-motor planning ability.
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Change from baseline in PPV at 4 weeks
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Reaction time (RT)
기간: Change from baseline in RT at 4 weeks
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The reaction time is collected by a 7-camera motion analysis system (VICON MX 3-D, Oxford Metrics Inc., Oxford, UK) from unilateral and bilateral reaching tasks of pressing the desk bell.
RT is the time required to prepare a motor response toward an external signal and indicates speed of motor planning.
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Change from baseline in RT at 4 weeks
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Action Research Arm Test (ARAT)
기간: Change from baseline in ARAT at 4 weeks, change from baseline in ARAT at 8 weeks, change from baseline in ARAT at 16 weeks, change from baseline in ARAT at 28 weeks
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The ARAT assesses the ability to handle objects with 19 items divided into 4 subscales of grasp, grip, pinch, and gross movement by 4-level ordinal scale.
Higher the score, better the performance.
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Change from baseline in ARAT at 4 weeks, change from baseline in ARAT at 8 weeks, change from baseline in ARAT at 16 weeks, change from baseline in ARAT at 28 weeks
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Medical Research Council scale (MRC)
기간: Change from baseline in MRC at 4 weeks, change from baseline in MRC at 8 weeks, change from baseline in MRC at 16 weeks, change from baseline in MRC at 28 weeks
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The MRC scale assesses muscle power with scores ranging from 0 (no contraction) to 5 (normal power).
The muscle strength of shoulder flexors/abductors, elbow flexors/extensors, wrist flexors/extensors, and finger extensors are graded.
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Change from baseline in MRC at 4 weeks, change from baseline in MRC at 8 weeks, change from baseline in MRC at 16 weeks, change from baseline in MRC at 28 weeks
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MYOTON-3
기간: Change from baseline in MYOTON-3 at 4 weeks, change from baseline in MYOTON-3 at 8 weeks, change from baseline in MYOTON-3 at 16 weeks, change from baseline in MYOTON-3 at 28 weeks
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MYOTON-3 is used to assess muscle tone of the affected upper limb.
There are three measurement parameters in the MYOTON-3: F - Frequency, Hz, characterizing muscle tone; D - Decrement, characterizing muscle elasticity; and S - Stiffness, N/m, characterizing muscle stiffness.
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Change from baseline in MYOTON-3 at 4 weeks, change from baseline in MYOTON-3 at 8 weeks, change from baseline in MYOTON-3 at 16 weeks, change from baseline in MYOTON-3 at 28 weeks
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Accelerometers
기간: Change from baseline in accelerometers at 4 weeks, change from baseline in accelerometers at 8 weeks, change from baseline in accelerometers at 16 weeks, change from baseline in accelerometers at 28 weeks
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Accelerometers are used to provide a direct and objective measure of the amount of the impaired arm movement outside the laboratory.
In this project, acceleration is sampled at 10 Hz and summed over a user- specified epoch.
The recording epoch in this study is 2 seconds; recording capacity is approximately 72 hours.
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Change from baseline in accelerometers at 4 weeks, change from baseline in accelerometers at 8 weeks, change from baseline in accelerometers at 16 weeks, change from baseline in accelerometers at 28 weeks
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Peak velocity (PV)
기간: Change from baseline in PV at 4 weeks
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PPV is collected by a 7-camera motion analysis system (VICON MX 3-D, Oxford Metrics Inc., Oxford, UK) from unilateral and bilateral reaching tasks of pressing the desk bell.
PV corresponds to the changeover from the acceleration to the deceleration phase and is related to the force produced.
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Change from baseline in PV at 4 weeks
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Trunk related Kinematic variables
기간: Change from baseline in trunk related kinematic variables at 4 weeks
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The parameter of movement units is collected by a 7-camera motion analysis system (VICON MX 3-D, Oxford Metrics Inc., Oxford, UK) from unilateral and bilateral reaching tasks of pressing the desk bell.
These parameters include trunk displacement, trunk flexion angular change, trunk-arm delay, shoulder flexion & trunk flexion correlation, and elbow extension & trunk flexion correlation.
These variables indicate the degree of trunk compensatory movement and interjoint coordination.
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Change from baseline in trunk related kinematic variables at 4 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Motor Activity Log (MAL)
기간: Change from baseline in MAL at 4 weeks, change from baseline in MAL at 8 weeks, change from baseline in MAL at 16 weeks, change from baseline in MAL at 28 weeks
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The MAL is a semi-structured interview of patients to assess the amount of use (AOU) and quality of movement (QOM) of the affected upper extremity in 30 important daily activities using a 6-point ordinal scale.
Higher scores indicate superior amount and quality of use in affected upper extremity.
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Change from baseline in MAL at 4 weeks, change from baseline in MAL at 8 weeks, change from baseline in MAL at 16 weeks, change from baseline in MAL at 28 weeks
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ABILHAND Questionnaire
기간: Change from baseline in ABILHAND at 4 weeks, change from baseline in ABILHAND at 8 weeks, change from baseline in ABILHAND at 16 weeks, change from baseline in ABILHAND at 28 weeks
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The ABILHAND is an inventory of 56 manual activities measuring the patient's perceived difficulty in daily activities.
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Change from baseline in ABILHAND at 4 weeks, change from baseline in ABILHAND at 8 weeks, change from baseline in ABILHAND at 16 weeks, change from baseline in ABILHAND at 28 weeks
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Stroke Impact Scale Version 3.0 (SIS 3.0)
기간: Change from baseline in SIS at 4 weeks, change from baseline in SIS at 8 weeks, change from baseline in SIS at 16 weeks, change from baseline in SIS at 28 weeks
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The SIS 3.0 is a stroke-specific instrument of health-related quality of life and contains 59 items measuring 8 domains.
Items are rated on a 5-point Likert scale with lower scores indicate greater difficulty in task completion during the past week.
Aggregate scores, ranges from 0 to 100, are generated for each domain.
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Change from baseline in SIS at 4 weeks, change from baseline in SIS at 8 weeks, change from baseline in SIS at 16 weeks, change from baseline in SIS at 28 weeks
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Nottingham Extended Activities of Daily Living Scale (NEADL)
기간: Change from baseline in NEADL at 4 weeks, change from baseline in NEADL at 8 weeks, change from baseline in NEADL at 16 weeks, change from baseline in NEADL at 28 weeks
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The NEADL consists of 22 activity items, scoring on the basis of the required level of assistance.
The range of total score is 0-66, and higher score representing better function.
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Change from baseline in NEADL at 4 weeks, change from baseline in NEADL at 8 weeks, change from baseline in NEADL at 16 weeks, change from baseline in NEADL at 28 weeks
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revised Nottingham Sensory Assessment (rNSA)
기간: Change from baseline in rNSA at 4 weeks, change from baseline in rNSA at 8 weeks, change from baseline in rNSA at 16 weeks, change from baseline in rNSA at 28 weeks
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The rNSA examines the sensory function of the affected arm and includes tactile sensation, proprioception, and stereognosis subtests.
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Change from baseline in rNSA at 4 weeks, change from baseline in rNSA at 8 weeks, change from baseline in rNSA at 16 weeks, change from baseline in rNSA at 28 weeks
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Fugl-Meyer Assessment-Sensory (FMA-S)
기간: Change from baseline in FMA-S at 4 weeks, change from baseline in FMA-S at 8 weeks, change from baseline in FMA-S at 16 weeks, change from baseline in FMA-S at 28 weeks
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The FMA-S contains 12 three-point items, four for light touch and eight for position sense.
The total score ranges from 0 to 24.
The sensation for light touch will be estimated subjectively.
The patient will be asked whether he or she feels that light touches on both arms and the palmar surface of the hands give the same qualitative and quantitative impressions.
The position sense of the joints will involve tests for interphalangeal joint of the thumb, the wrist, the elbow, and the shoulder joint
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Change from baseline in FMA-S at 4 weeks, change from baseline in FMA-S at 8 weeks, change from baseline in FMA-S at 16 weeks, change from baseline in FMA-S at 28 weeks
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8-OHdG: A Biomarker of Oxidative Stress
기간: Change from baseline in 8-OHdG at 4 weeks, change from baseline in 8-OHdG at 8 weeks, change from baseline in 8-OHdG at 16 weeks, change from baseline in 8-OHdG at 28 weeks
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Urinary 8-OHdG is a stable and integral biomarker of oxidative DNA damage.
About 10 mL to 15 mL urine samples of the patients are collected in the centrifugal tubes before and after rehabilitation interventions.
The samples is transported with dry ice under 4°C and preserved in a -80°C refrigerator before analysis.
A highly sensitive and selective method, using isotope- dilution liquid chromatography with tandem mass spectrometry (LC/MS/MS), is used to determine the urinary 8-OHdG levels.
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Change from baseline in 8-OHdG at 4 weeks, change from baseline in 8-OHdG at 8 weeks, change from baseline in 8-OHdG at 16 weeks, change from baseline in 8-OHdG at 28 weeks
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Multidimensional Fatigue Symptom Inventory (MFSI)
기간: Change from baseline in MFSI at 4 weeks, change from baseline in MFSI at 8 weeks, change from baseline in MFSI at 16 weeks, change from baseline in MFSI at 28 weeks
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The general subscale of the MFSI is used to measure general fatigue of the patients.
It includes 6 items with a total score ranging from 0 (not at all) to 24 (extremely).
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Change from baseline in MFSI at 4 weeks, change from baseline in MFSI at 8 weeks, change from baseline in MFSI at 16 weeks, change from baseline in MFSI at 28 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Keh-chung Lin, ScD, School of Occupational Therapy, College of Medicine, National Taiwan University
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
2011년 8월 1일
기본 완료 (예상)
2014년 7월 1일
연구 완료 (예상)
2014년 7월 1일
연구 등록 날짜
최초 제출
2012년 7월 19일
QC 기준을 충족하는 최초 제출
2012년 7월 29일
처음 게시됨 (추정)
2012년 8월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2012년 8월 1일
QC 기준을 충족하는 마지막 업데이트 제출
2012년 7월 29일
마지막으로 확인됨
2012년 7월 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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