인간-기계 상호작용을 통한 근전도 유도 신경-근육 조화 증진(NICE) 재활 (NICE)
2026년 6월 15일 업데이트: Jinsook Roh, University of Houston
신경-근육 조화 강화(NICE) 재활
이 연구의 목적은 뇌졸중 환자들이 인간-기계 상호작용을 통해 시각적으로 안내받아 시너지 효과를 내는 근육 그룹을 개별적으로 활성화하도록 하는 새로운 신경근 조절 신호 기반 전략인 Neuro-Intermuscular Coordination Enhancement (NICE) 재활 치료법을 개발하는 것입니다.
궁극적으로, 이 개발은 더 나은 임상 운동 회복, 더 나은 삶의 질, 그리고 장애와 관련된 의료비 절감으로 이어질 것입니다.
연구 개요
상태
아직 모집하지 않음
정황
상세 설명
뇌졸중은 장기적인 심각한 장애의 주요 원인으로, 940만 명의 미국인에게 영향을 미칩니다. 매년 미국에서만 약 80만 명이 뇌졸중을 겪습니다. 만성 상지 운동 장애는 장애의 주요 요인입니다; 일상생활에서 영향을 받은 상지의 기능적 사용은 독립성 증대, 직장 복귀 및 전반적인 삶의 질 향상을 위한 핵심 요소입니다. 따라서 장기적 장애를 해결하기 위한 효과적이고 혁신적인 치료는 주요 공중 보건 필요 사항이자 경제적 필수 요소입니다.
이 연구는 상지의 근육 조정을 향상시켜 관절 간 조정 및 운동 기능을 목표로 하고 개선하기 위한 혁신적인 인간-기계 상호작용 플랫폼을 개발할 것입니다. 이 연구에서는 총 38명의 만성 뇌졸중 생존자가 신경근 조정 유도 운동(치료 그룹) 또는 힘 유도 운동(대조군) 중 두 가지 재활 전략에 무작위로 배정될 것입니다. 포함 기준은 주로 다음과 같습니다: (1) 최소 6개월 전에 허혈성 또는 출혈성 뇌졸중을 경험한 경우(만성 뇌졸중); (2) 21세에서 80세 사이; (3) 지난 3개월 동안 영향을 받은 팔에 보툴리눔 독소 치료를 받지 않은 경우; (4) 과제 이해 또는 동의 능력에 영향을 미치는 인지 장애가 없는 경우.
이 연구는 두 재활 운동이 근육 조정, 표준화된 임상 점수, 운동학 및 뇌파에 미치는 효과를 평가할 것입니다.
연구 유형
중재적
등록 (추정된)
48
단계
- 초기 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Jinsook Roh, PhD
- 전화번호: 7137432578
- 이메일: jroh@Central.UH.EDU
연구 장소
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Texas
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Houston, Texas, 미국, 77045
- University of Houston
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연락하다:
- JIN-SOOK ROH, PhD
- 전화번호: 6173680050
- 이메일: jsroh@central.uh.edu
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수석 연구원:
- Jinsook Roh, PhD
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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
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
포함 기준:
- 허혈성 또는 출혈성 뇌졸중
- 21세에서 80세 사이
- 장애가 있는 팔에 3개월 이내 보툴리눔 독소 치료를 받지 않은 경우
- 팔꿈치와 어깨 주변 MAS ≤ 3
제외 기준:
- 상지에 관련된 정형외과적 장애가 있는 경우;
- 정보에 입각한 동의나 프로토콜의 성공적인 완료를 방해할 만큼 충분한 인지 장애가 있는 경우(몬트리올 인지 평가(MoCA) 점수 ≤ 26);
- 다른 신경계 질환의 병력이 있는 경우;
- 상지의 관절 위치 감각 마비가 있는 경우;
- 임신 중이거나 임신 가능성이 있는 경우(자가 보고);
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: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Neuromuscular coordination enhancement (NICE) intervention
Post-stroke participants will perform a center-out task by activating individual motor modules (generating coordinated isometric contractions of muscles) to move the cursor on a screen while electromyographic (EMG) signals are recorded.
Activation of each muscle (or muscle group) will be mapped to 1 of 4 directions within the multi-dimensional cursor space.
We will derive the cursor position in real time using Motor module activation magnitudes recorded from arm muscles.
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Neuro-Intermuscular Coordination Enhancement (NICE) is a motor module-guided rehabilitation intervention designed to improve upper-extremity motor recovery after stroke by retraining impaired intermuscular coordination patterns. Participants perform isometric upper-extremity force-generation tasks using a human-machine interface while receiving real-time visual feedback derived from motor module recruitment signals calculated from surface electromyography (EMG). Individualized motor module targets are derived from the participant's less-affected upper extremity and used to guide selective recruitment of impaired coordination patterns in the more-affected upper extremity. Participants will complete 18 one-hour training sessions over six weeks (3 sessions/week). During training, participants perform repetitive target-matching tasks that require preferential recruitment of specific motor modules while minimizing unintended activation of non-target modules. |
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활성 비교기: EMG-amplitude biofeedback exercise
Participants will perform a center-out target matching tasks where individual muscle EMGs are used to move a cursor on the visual feedback display to match one of 4 different targets presented to them.
Here, just the EMG amplitude, and not the coordination is focused on.
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EMG Amplitude Biofeedback Exercise is an active comparator rehabilitation intervention designed to improve upper-extremity motor function after stroke through targeted muscle activation training.
Participants perform isometric upper-extremity exercises using a human-machine interface with real-time EMG amplitude-based visual feedback.
Individualized muscle activation targets derived from the less-affected upper extremity guide training of the more-affected upper extremity.
Participants will complete 18 one-hour sessions over 6 weeks (3 sessions/week).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Fugl-Meyer Assessment (FMA) score
기간: Baseline, six- week, 10-week, and 18-week follow-ups.
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Motor impairment after stroke will be measured by upper extremity FMA (UE-FMA).
The maximum UE-FMA motor score is 66 (i.e., 0: complete motor impairment; 66: normal motor performance).
Each item is scored on a 3-point scale (0 = cannot perform, 1 = performs partially, 2 = performs fully).
The FMA score reflects the level of upper extremity motor impairment.
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Baseline, six- week, 10-week, and 18-week follow-ups.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Similarity Score of Intermuscular Coordination Patterns (or Motor Modules)
기간: Baseline, six- week, 10-week, and 18-week follow-ups.
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Surface EMGs will be recorded from 8 key arm muscles during a 54-target isometric force generation task.
A dimensionality reduction method (non-negative matrix factorization (NNMF)) will be applied to identify intermuscular coordination patterns - operational definition of motor modules in the field of motor neuroscience.
They are mathematically 8-dimensional unit vectors.
Similarity score is the scalar product (or dot product) between a pair of intermuscular coordination patterns in comparison (i.e., motor modules).
We compute the similarity score between the less-affected and the more-affected arms.
Also, surface EMGs will be recorded from 8 key arm muscles during 3D dynamic reaching tasks.
NNMF will be applied to EMGs to identify and compare intermuscular coordination patterns.
Similarity score is the scalar product between motor modules (i.e., intermuscular coordination patters) of the more-affected arm in stroke group and dominant arm in healthy group.
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Baseline, six- week, 10-week, and 18-week follow-ups.
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Kinematic Synergy Similarity Score
기간: Baseline, six-week, 10-week, and 18-week follow-ups.
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Kinematic synergies are a representation of multi-joint coordination.
It will be identified using NNMF algorithm applied to the joint kinematic data obtained from 3D dynamic point-to-point reaching tasks.
Kinematic synergy similarity between stroke and healthy will be calculated using their scalar product.
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Baseline, six-week, 10-week, and 18-week follow-ups.
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Pairwise joint angle-to-angle correlation value
기간: Baseline, six- week, 10-week, and 18-week follow-ups.
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Pairwise joint angle-to-angle correlation is a way to see the joint coupling using kinematic data.
It will be calculated using Pearson's correlation coefficient between joint angles during the point-to-point reaching task.
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Baseline, six- week, 10-week, and 18-week follow-ups.
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Active range of motion
기간: Baseline, six-week, 10-week, and 18-week follow-ups.
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The active range of motion will be calculated from full active range tasks for shoulder flexion/extension, internal/external rotation, abduction/adduction, elbow flexion/extension, and wrist pronation/supination. Kinematic joint positions and angles will be used to calculate the same.
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Baseline, six-week, 10-week, and 18-week follow-ups.
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EEG Spectral power ratios
기간: Baseline and six-week follow-up.
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EEG-derived spectral power ratios will be calculated, in resting and task conditions, across different frequency bands (delta, theta, alpha, beta, gamma) and different events (onset, successful match, etc.) across four different directions of target match.
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Baseline and six-week follow-up.
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EEG-derived Brain Symmetry Index
기간: Baseline and six-week follow-up.
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The revised brain symmetry index with EEG signals will be computed in the resting state during eyes open and closed conditions.
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Baseline and six-week follow-up.
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Cortico-muscular connectivity
기간: Baseline and six-week follow-up.
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Functional connectivity using a directed transfer function will be computed to identify the information flow and coherence among EEG and EMG signals in the desired brain region and muscle activation associated with directional 4-target isometric force generation.
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Baseline and six-week follow-up.
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Cortico-cortical connectivity
기간: Baseline and six-week follow-up.
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Functional connectivity using a directed transfer function will be computed to identify the information flow and coherence among EEG signals from different regions of interest (sources, e.g., ipsi and contralesional fronto-parietal regions, primary motor cortex and somatosensory cortices).
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Baseline and six-week follow-up.
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Participant recruitment rate
기간: From participant recruitment beginning to enrollment completion
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Recruitment rate will be calculated as the number of participants enrolled per month during the recruitment period.
This is a feasibility outcome.
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From participant recruitment beginning to enrollment completion
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Participant intervention adherence
기간: Throughout the 6-week intervention period.
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Intervention adherence will be calculated as the percentage of scheduled intervention sessions completed by each participant.
This is a feasibility outcome.
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Throughout the 6-week intervention period.
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Participant Tolerance of the Intervention
기간: Throughout the 6-week intervention period.
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Participant tolerance will be measured as the number and percentage of participants who complete intervention sessions without stopping due to discomfort, fatigue, pain, or other intolerance-related reasons.
This is a feasibility outcome.
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Throughout the 6-week intervention period.
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Intervention fidelity
기간: Throughout the 6-week intervention period.
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Intervention fidelity will be calculated as the percentage of intervention sessions delivered according to the study protocol.
This is a feasibility outcome.
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Throughout the 6-week intervention period.
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Dose equivalence between the intervention groups
기간: Throughout the 6-week intervention period.
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Dose equivalence will be assessed by comparing total intervention dose between groups, measured as total minutes of training and/or number of completed sessions per participant.
This is a feasibility outcome.
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Throughout the 6-week intervention period.
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NICE-specific training feasibility
기간: Throughout the 6-week intervention period.
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NICE-specific feasibility will be assessed as the percentage of NICE intervention sessions in which the NICE training system/protocol is successfully implemented as intended.
This is a feasibility outcome.
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Throughout the 6-week intervention period.
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Participant retention rate
기간: Baseline, six-week, 10-week, and 18- week follow-ups and throughout the 6-week intervention period.
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Retention rate will be calculated as the percentage of enrolled participants who complete each scheduled follow-up assessment.
This is a feasibility outcome.
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Baseline, six-week, 10-week, and 18- week follow-ups and throughout the 6-week intervention period.
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Successful acquisition of study data
기간: Baseline, six-week, 10-week, and 18- week follow-ups and throughout the 6-week intervention period.
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Successful data acquisition will be calculated as the percentage of expected EMG, EEG, kinematic, and clinical outcome datasets successfully collected and usable for analysis.
This is a feasibility outcome.
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Baseline, six-week, 10-week, and 18- week follow-ups and throughout the 6-week intervention period.
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Box and Block Test (BBT) score
기간: Baseline, six-week follow-up, and 10-week follow-up. Keeping a 18-week follow-up as an exploratory time point.
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The gross manual dexterity and upper extremity coordination will be assessed through BBT, which involves transfer of blocks from one compartment of a box to the other within 60 seconds.
The score is the number of blocks successfully transferred to the other side within 60 seconds.
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Baseline, six-week follow-up, and 10-week follow-up. Keeping a 18-week follow-up as an exploratory time point.
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Modified Ashworth Scale (MAS) score
기간: Baseline, six-week follow-up, and 10-week follow-up. Keeping a 18-week follow-up as an exploratory time point.
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The increase in muscle tone will be assessed through MAS around the elbow and shoulder.
MAS score ranges from 0 to 5. The MAS score reflects the severity of muscle spasticity.
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Baseline, six-week follow-up, and 10-week follow-up. Keeping a 18-week follow-up as an exploratory time point.
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Wolf Motor Function Test (WMFT) score
기간: Baseline, six-week follow-up, and 10-week follow-up. Keeping a 18-week follow-up as an exploratory time point.
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Motor function will be assessed through WMFT, which evaluates both the time and quality of performance across 17 tasks that range from simple joint movements to complex functional activities (like lifting a can or folding a towel).
Performance Time (sec) is measured, with a maximum time limit (usually 120 seconds).
Functional Ability Scale rates the quality of movement, using a 6-point ordinal scale (0 = Does not attempt with the involved arm, 1 = Attempted but cannot complete task, 2 = Completes task with great difficulty or poor movement quality, 3 = Completes task with moderate difficulty or noticeable impairment, 4 = Completes task with minor difficulty or near-normal movement, 5 = Normal movement quality and speed).
The WMFT score assesses upper extremity motor function.
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Baseline, six-week follow-up, and 10-week follow-up. Keeping a 18-week follow-up as an exploratory time point.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Jinsook Roh, PhD, University of Houston
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Roh J, Cheung VC, Bizzi E. Modules in the brain stem and spinal cord underlying motor behaviors. J Neurophysiol. 2011 Sep;106(3):1363-78. doi: 10.1152/jn.00842.2010. Epub 2011 Jun 8.
- Dewald JP, Sheshadri V, Dawson ML, Beer RF. Upper-limb discoordination in hemiparetic stroke: implications for neurorehabilitation. Top Stroke Rehabil. 2001 Spring;8(1):1-12. doi: 10.1310/WA7K-NGDF-NHKK-JAGD.
- Nordin AD, Hairston WD, Ferris DP. Faster Gait Speeds Reduce Alpha and Beta EEG Spectral Power From Human Sensorimotor Cortex. IEEE Trans Biomed Eng. 2020 Mar;67(3):842-853. doi: 10.1109/TBME.2019.2921766. Epub 2019 Jun 13.
- Roh J, Beer RF, Lai A, Rho M, Karvelas KR, Nader AM, Kendall MC, Rymer WZ. The Effects of Selective Muscle Weakness on Muscle Coordination in the Human Arm. Appl Bionics Biomech. 2018 Sep 19;2018:5637568. doi: 10.1155/2018/5637568. eCollection 2018.
- Park JH, Lee H, Kwon HJ, Shin JH, Roh J, Park HS. Feasibility of Isokinetic Training to Modify Coupling of Upper Limb Muscle Synergy Activation in Stroke-affected Upper Limb. Annu Int Conf IEEE Eng Med Biol Soc. 2023 Jul;2023:1-4. doi: 10.1109/EMBC40787.2023.10339985.
- Portilla-Jimenez M, Seo G, Houston M, Hong YNG, Li S, Park HS, Zhang Y, Roh J. Improving impaired intermuscular coordination after stroke through synergy-guided human-machine interaction: a pilot study. Annu Int Conf IEEE Eng Med Biol Soc. 2024 Jul;2024:1-4. doi: 10.1109/EMBC53108.2024.10782001.
- Seo G, Park JH, Park HS, Roh J. Developing new intermuscular coordination patterns through an electromyographic signal-guided training in the upper extremity. J Neuroeng Rehabil. 2023 Sep 1;20(1):112. doi: 10.1186/s12984-023-01236-2.
- Seo G, Kishta A, Mugler E, Slutzky MW, Roh J. Myoelectric interface training enables targeted reduction in abnormal muscle co-activation. J Neuroeng Rehabil. 2022 Jul 1;19(1):67. doi: 10.1186/s12984-022-01045-z.
- Li S. Stroke Recovery Is a Journey: Prediction and Potentials of Motor Recovery after a Stroke from a Practical Perspective. Life (Basel). 2023 Oct 15;13(10):2061. doi: 10.3390/life13102061.
유용한 링크
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 (추정된)
2027년 8월 1일
기본 완료 (추정된)
2032년 8월 1일
연구 완료 (추정된)
2032년 8월 1일
연구 등록 날짜
최초 제출
2025년 10월 22일
QC 기준을 충족하는 최초 제출
2026년 4월 8일
처음 게시됨 (실제)
2026년 4월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 15일
마지막으로 확인됨
2026년 6월 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. .