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뇌졸중 재활을 위한 수동 로봇: 타당성 조사

2026년 11월 7일 업데이트: Chandramouli Krishnan, University of Michigan

뇌졸중 재활을 위한 수동 로봇

The purpose of this study is to examine the feasibility and effectiveness of a novel, multimodal approach that combines passive devices with noninvasive neuromuscular stimulation for upper extremity rehabilitation after stroke.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

About 800,000 individuals suffer from a stroke every year in the United States. The majority of stroke survivors often experience lingering deficits in upper extremity function. High-end robotic devices can improve outcomes and clinical productivity; however, these devices are expensive and bulky, making them not practical for many clinical or home environments. This study aims to evaluate the feasibility of low-cost non-motorized devices for stroke rehabilitation in a long-term intervention. The intervention will involve training with a table-top, semi-passive (i.e., no motors) exercise equipment called SepaRRo and commonly-used neuromuscular stimulation. The stimulation will be provided during functional activities using a custom controller (NeuRRoFES) to trigger stimulation. These instruments are designed to provide flexible, compliant assistance/resistance to improve upper extremity function and can be used in a home setting. The study will measure technical feasibility (e.g., qualitative survey, adherence, time on task, retention, ability to perform tasks) as well as clinical feasibility (i.e., changes in biomechanical, neurophysiological, and functional measures) of an intervention with these devices in stroke survivors. The findings aim to support the development of affordable, home-use rehabilitation systems for stroke patients.

연구 유형

중재적

등록 (추정된)

4

단계

  • 해당 없음

연락처 및 위치

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

연구 연락처

  • 이름: Chandramouli Krishnan, PT, PhD
  • 전화번호: 7349364031
  • 이메일: mouli@umich.edu

연구 연락처 백업

연구 장소

  • 미국
    • Michigan
      • Ann Arbor, Michigan, 미국, 48108
        • 모병
        • University of Michigan - NeuRRo Lab
        • 수석 연구원:
          • Chandramouli Krishnan, PT PhD
        • 연락하다:

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 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Age 18 to 75 years;
  • Ischemic or hemorrhagic stroke confirmed by CT, MRI, or clinical criteria;
  • No major deficits of sensation or proprioception;

Exclusion Criteria:

  • Bilateral stroke
  • Unable to think clearly and remember (Mini-Mental State Exam score < 22 and miniMOCA < 8);
  • Uncontrolled Diabetes or Hypertension;
  • Severe limitations of joint range of motion that will lead to inability of testing
  • Severe spasticity and joint contractures that will lead to inability of testing
  • Complete paresis with no possible movements
  • Severe aphasia
  • Any other medical condition that will significantly impact the study results
  • Unable to obtain reliable motor evoked potentials
  • Are pregnant or are actively trying to conceive
  • Have a recent history of repeated fainting spells or syncope.
  • Have a recent history of seizure (epilepsy) while on anti-seizure medication
  • Have a recent history of skull fracture/head injury
  • Have metal implants in the skull
  • Have cardiac pacemakers

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 장치 타당성
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Robotic Intervention

Participants will receive upper extremity rehabilitation using SepaRRo and NeuRRoFES 2-5 times per week for 2-6 weeks
장치: Functional Training with SepaRRo and NeuRRoFES

Participants will perform functional movements (e.g., reach for targets) with their extremities. During movements, the devices will be used to assist or resist their motion. Participants may receive biofeedback of their movements to better engage them in training. Participants may receive assistance from the devices (including neuromuscular stimulation) and/or their less-impaired limb.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Device Survey For Feasibility
기간: Post-intervention (immediately following last session of intervention)

Subjective feedback regarding feasibility of the device for training
Post-intervention (immediately following last session of intervention)

기타 결과 측정

결과 측정
측정값 설명
기간
Retention
기간: Post-intervention (immediately following last session of intervention)

Measure of how many participants completed intervention
Post-intervention (immediately following last session of intervention)
Adherence
기간: Post-intervention (immediately following last session of intervention)

Measure of percentage of sessions completed
Post-intervention (immediately following last session of intervention)
Upper extremity Fugl-Meyer Score
기간: Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively.

Changes in upper extremity Fugl-Meyer score from before the intervention (from baseline) to after its completion using publicly available scoring sheets. The Fugl-Meyer score is a measure of functional impairment and runs from 0 to 66 points, with higher numbers reflecting better outcome.
Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively.
Reachable workspace
기간: Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively

Changes in reachable workspace from before the intervention (from baseline) to after its completion). The reachable workspace area will be measured with SepaRRo obtained from optical encoders mounted in the device.
Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
Voluntary hand opening
기간: Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively

Changes in voluntary ability to open the hand from before the intervention (from baseline to after its completion). Voluntary hand opening will be measured with motion capture equipment.
Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
Action Research Arm Test Score
기간: Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively

Changes in the Action Research Arm Test Score from before the intervention (from baseline) to after its completion using publicly available scoring sheets. The Action Research Arm Test is a measure of arm functional ability and runs from 0 to 57 points, with higher numbers reflecting better outcome.
Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
Box and Block (BBT)
기간: Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively

Changes in functional measure of arm disability (BBT) from before the intervention (from baseline) to after its completion using publicly available scoring sheets.
Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
Hand Strength
기간: Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively

Changes in force produced by the hand from before the intervention (from baseline) to after its completion as measured by force production recorded with a dynamometer
Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
Arm strength
기간: Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively

Changes in force produced by the arm from before the intervention (from baseline) to after its completion as measured by force production recorded with a dynamometer
Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
Muscle coordination
기간: Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively

Changes in muscle coordination of the upper extremity muscles as measured using surface electromyography between before the intervention (from baseline) to after its completion.
Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
Joint coordination
기간: Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively

Changes in coordination of the upper extremity joints as measured motion capture between before the intervention (from baseline) to after its completion.
Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
Corticospinal excitability
기간: Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively

Changes in corticospinal excitability of the upper extremity muscles as measured using surface electromyography and transcranial magnetic stimulation between before the intervention (from baseline) to after its completion
Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Michigan

수사관

  • 수석 연구원: Chandramouli Krishnan, PT, PhD, University of Michigan

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)

2025년 11월 5일

기본 완료 (추정된)

2027년 10월 1일

연구 완료 (추정된)

2027년 10월 1일

연구 등록 날짜

최초 제출

2025년 10월 15일

QC 기준을 충족하는 최초 제출

2025년 10월 16일

처음 게시됨 (실제)

2025년 10월 20일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 7일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • HUM00087962

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

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. .

구독하다