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Combined Repetitive Transcranial Magnetic Stimulation and Robot-Assisted Upper Arm Training in Subacute Stroke Patients

2019년 3월 14일 업데이트: Yonsei University

Combined Repetitive Transcranial Magnetic Stimulation and Robot-Assisted Upper Arm Training in Subacute Stroke Patients : Randomized Controlled Trial

This study was designed to establish the clinical evidence for effect of Robot-Assisted upper arm training and Repetitive Transcranial Magnetic Stimulation on upper limb function of subacute stroke patients.

  • Purpose : to elucidate the effect of Robot-Assisted upper arm training and Repetitive Transcranial Magnetic Stimulation on upper limb function of stroke patients compared to conventional occupational therapy
  • Subjects : total 99 patients with stroke whose upper limb functions are impaired
  • Intervention : 4 weeks of therapy (5 days per week)
  • Studies : upper limb functional assessment (FMA, MFT, WMFT), computerized motion analysis
  • Evaluation plan : 1) pre-intervention, 2) post-2 weeks of intervention, 3) post-4 weeks of intervention, 4) 4 weeks after end of intervention

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

108

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 대한민국
      • Seoul, 대한민국, 03722
        • Department of Rehabilitation Medicine, Severance Hospital, Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine

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 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Upper FMA 7-38
  • Hemiplegic patients within 6months after stroke onset
  • male or female, 20 years older

Exclusion Criteria:

  • Patients with cognitive impairment who are unable to comply with protocol-required procedure
  • Quadriplegic or double hemiplegic patients
  • Patients with musculoskeletal disease, peripheral nerve disease in upper extremity
  • Patients with lower motor neuron disease
  • Patients who cannot perform rTMS
  • Pregnant woman

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Robot and rTMS
Robot-Assisted upper arm training and Repetitive Transcranial Magnetic Stimulation group(intervention group 1)
장치: Armeo and rTMS

The Armeo, a robot with a spring mechanism allowing adjustable arm weight support, can generate assistive forces of up to 66N in flexion/extension and up to 30N for the arm and forearm respectively. This robot integrates seven angle sensors and one pressure sensor that allow direct interaction between the motion of the patient's arm and the associated therapy software. rTMS is a magnetic method used to stimulate small regions of the brain.

The Robot and rTMS group will receive the robot-assisted upper arm training and rTMS for 5 times per week, for 4 weeks. And all patients of three groups will receive the additional conventional occupational therapy for 30 minutes daily 5 times per week, for 4 weeks.

다른 이름들:
  • 반복 경두개 자기 자극(rTMS)
  • Robot-Assisted upper arm training(Armeo)
실험적: Robot
Robot-Assisted upper arm training group(intervention group2)
장치: Armeo
The Armeo, a robot with a spring mechanism allowing adjustable arm weight support, can generate assistive forces of up to 66N in flexion/extension and up to 30N for the arm and forearm respectively. This robot integrates seven angle sensors and one pressure sensor that allow direct interaction between the motion of the patient's arm and the associated therapy software. The Robot group will receive the robot-assisted upper arm training for 30 minutes daily 5 times per week, for 4 weeks. And all patients of three groups will receive the additional conventional occupational therapy for 30 minutes daily 5 times per week, for 4 weeks.
다른 이름들:
  • Robot-Assisted upper arm training(Armeo)
활성 비교기: Conventional
Conventional training group(control group)
다른: Control group
The conventional group will receive occupational therapy for 30 minutes daily 5 times per week, for 4 weeks instead of Robot or rTMS. And all patients of three groups will receive the additional conventional occupational therapy for 30 minutes daily 5 times per week, for 4 weeks.
다른 이름들:
  • 기존의 훈련

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Fugl-Meyer Assessment (FMA)
기간: 1 minute before the first intervention
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
1 minute before the first intervention
Fugl-Meyer Assessment (FMA)
기간: 2 weeks after the first intervention
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
2 weeks after the first intervention
Fugl-Meyer Assessment (FMA)
기간: 4 weeks after the first intervention
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
4 weeks after the first intervention
Fugl-Meyer Assessment (FMA)
기간: 4 weeks after the final intervention
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
4 weeks after the final intervention

2차 결과 측정

결과 측정
측정값 설명
기간
Wolf motor function test
기간: 1 minute before the first intervention
The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks.
1 minute before the first intervention
Wolf motor function test
기간: 2 weeks after the first intervention
The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks.
2 weeks after the first intervention
Wolf motor function test
기간: 4 weeks after the first intervention
The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks.
4 weeks after the first intervention
Wolf motor function test
기간: 4 weeks after the final intervention
The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks.
4 weeks after the final intervention
Manual Function test
기간: 1 minute before the first intervention
The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.
1 minute before the first intervention
Manual Function test
기간: 2 weeks after the first intervention
The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.
2 weeks after the first intervention
Manual Function test
기간: 4 weeks after the first intervention
The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.
4 weeks after the first intervention
Manual Function test
기간: 4 weeks after the final intervention
The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.
4 weeks after the final intervention
Kinematic data of computerized 3D motion analysis
기간: 1 minute before the first intervention
D motion analysis will be performed using a computerized motion analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the task of drinking from a cup
1 minute before the first intervention
Kinematic data of computerized 3D motion analysis
기간: 2 weeks after the first intervention
D motion analysis will be performed using a computerized motion analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the task of drinking from a cup
2 weeks after the first intervention
Kinematic data of computerized 3D motion analysis
기간: 4 weeks after the first intervention
D motion analysis will be performed using a computerized motion analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the task of drinking from a cup
4 weeks after the first intervention
Kinematic data of computerized 3D motion analysis
기간: 4 weeks after the final intervention
D motion analysis will be performed using a computerized motion analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the task of drinking from a cup
4 weeks after the final intervention

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Yonsei University

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)

2015년 6월 18일

기본 완료 (실제)

2018년 6월 26일

연구 완료 (실제)

2018년 6월 26일

연구 등록 날짜

최초 제출

2017년 1월 30일

QC 기준을 충족하는 최초 제출

2017년 2월 1일

처음 게시됨 (추정)

2017년 2월 3일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 3월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 3월 14일

마지막으로 확인됨

2019년 3월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 1-2014-0083

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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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