EMG誘導神経-筋間協調性向上（NICE）リハビリテーション：ヒューマン-マシンインタラクションを通じて (NICE)
2026年6月15日 更新者：Jinsook Roh、University of Houston
神経筋協調機能強化（NICE）リハビリテーション
本研究の目的は、神経筋協調性向上（NICE）リハビリテーションを開発することです。これは、ヒューマンマシンインタラクションを通じて、脳卒中患者が視覚的に誘導され、協調筋群を個別に活性化することを可能にする、新しい神経筋制御信号誘導戦略です。
最終的には、この開発により、臨床的な運動機能回復の向上、生活の質の向上、および障害に関連する医療費の削減が実現されます。
最終的には、この開発により、臨床的な運動機能回復の向上、生活の質の向上、および障害に関連する医療費の削減が実現されます。
調査の概要
状態
まだ募集していません
条件
詳細な説明
脳卒中は重度の長期的な障害の主要な原因であり、940万人のアメリカ人に影響を及ぼしています。 米国においても毎年約80万人が脳卒中を発症しています。 慢性的な上肢運動障害は障害の主要な要因であり、日常生活における患側上肢の機能的利用は、自立性の向上、職場復帰、全体的な生活の質にとって重要な要素です。 したがって、長期的な障害に対処するための効果的で革新的な治療は、主要な公衆衛生上のニーズであると同時に経済的必要性でもあります。
本研究では、上肢の筋協調を強化することで関節間協調と運動機能をターゲットにし改善する革新的な人間-機械インタラクションプラットフォームを開発します。 この研究では、合計38名の慢性脳卒中生存者を、神経筋協調誘導運動（NICE；治療群）または力誘導運動（対照群）の2つのリハビリテーション戦略に無作為に割り当てます。 主な対象基準は以下の通りです：（1）少なくとも6ヶ月前に虚血性または出血性脳卒中を経験していること（慢性脳卒中）、（2）21歳から80歳の間であること、（3）過去3ヶ月間に患側上肢でボツリヌス毒素治療を受けていないこと、（4）課題理解またはインフォームドコンセントの提供能力に影響を与える認知障害がないこと。
本研究では、両方のリハビリテーション運動が筋協調、標準化された臨床スコア、運動力学、脳波に及ぼす効果を評価します。
研究の種類
介入
入学 (推定)
48
段階
- 初期フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Jinsook Roh, PhD
- 電話番号：7137432578
- メール：jroh@Central.UH.EDU
研究場所
-
-
Texas
-
Houston、Texas、アメリカ、77045
- University of Houston
-
コンタクト：
- JIN-SOOK ROH, PhD
- 電話番号：6173680050
- メール：jsroh@central.uh.edu
-
主任研究者：
- Jinsook Roh, PhD
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
選定基準:
- 虚血性または出血性脳卒中
- 21歳から80歳までの年齢
- 障害のある腕へのボツリヌス毒素投与を3ヶ月以内に受けていない
- 肘および肩周囲のMAS ≤ 3
除外基準:
- 上肢に関わる整形外科的障害を有すること;
- インフォームドコンセントまたはプロトコルの成功完了を妨げる十分な認知障害（モントリオール認知評価（MoCA）スコア ≤ 26）;
- 他の神経疾患の既往歴;
- 上肢の関節位置覚の麻痺;
- 妊娠中または妊娠の可能性がある（自己申告）;
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
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. |
|
アクティブコンパレータ：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.
|
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).
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Fugl-Meyer Assessment (FMA) score
時間枠：Baseline, six- week, 10-week, and 18-week follow-ups.
|
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.
|
Baseline, six- week, 10-week, and 18-week follow-ups.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Similarity Score of Intermuscular Coordination Patterns (or Motor Modules)
時間枠：Baseline, six- week, 10-week, and 18-week follow-ups.
|
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.
|
Baseline, six- week, 10-week, and 18-week follow-ups.
|
|
Kinematic Synergy Similarity Score
時間枠：Baseline, six-week, 10-week, and 18-week follow-ups.
|
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.
|
Baseline, six-week, 10-week, and 18-week follow-ups.
|
|
Pairwise joint angle-to-angle correlation value
時間枠：Baseline, six- week, 10-week, and 18-week follow-ups.
|
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.
|
Baseline, six- week, 10-week, and 18-week follow-ups.
|
|
Active range of motion
時間枠：Baseline, six-week, 10-week, and 18-week follow-ups.
|
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.
|
Baseline, six-week, 10-week, and 18-week follow-ups.
|
|
EEG Spectral power ratios
時間枠：Baseline and six-week follow-up.
|
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.
|
Baseline and six-week follow-up.
|
|
EEG-derived Brain Symmetry Index
時間枠：Baseline and six-week follow-up.
|
The revised brain symmetry index with EEG signals will be computed in the resting state during eyes open and closed conditions.
|
Baseline and six-week follow-up.
|
|
Cortico-muscular connectivity
時間枠：Baseline and six-week follow-up.
|
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.
|
Baseline and six-week follow-up.
|
|
Cortico-cortical connectivity
時間枠：Baseline and six-week follow-up.
|
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).
|
Baseline and six-week follow-up.
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Participant recruitment rate
時間枠：From participant recruitment beginning to enrollment completion
|
Recruitment rate will be calculated as the number of participants enrolled per month during the recruitment period.
This is a feasibility outcome.
|
From participant recruitment beginning to enrollment completion
|
|
Participant intervention adherence
時間枠：Throughout the 6-week intervention period.
|
Intervention adherence will be calculated as the percentage of scheduled intervention sessions completed by each participant.
This is a feasibility outcome.
|
Throughout the 6-week intervention period.
|
|
Participant Tolerance of the Intervention
時間枠：Throughout the 6-week intervention period.
|
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.
|
Throughout the 6-week intervention period.
|
|
Intervention fidelity
時間枠：Throughout the 6-week intervention period.
|
Intervention fidelity will be calculated as the percentage of intervention sessions delivered according to the study protocol.
This is a feasibility outcome.
|
Throughout the 6-week intervention period.
|
|
Dose equivalence between the intervention groups
時間枠：Throughout the 6-week intervention period.
|
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.
|
Throughout the 6-week intervention period.
|
|
NICE-specific training feasibility
時間枠：Throughout the 6-week intervention period.
|
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.
|
Throughout the 6-week intervention period.
|
|
Participant retention rate
時間枠：Baseline, six-week, 10-week, and 18- week follow-ups and throughout the 6-week intervention period.
|
Retention rate will be calculated as the percentage of enrolled participants who complete each scheduled follow-up assessment.
This is a feasibility outcome.
|
Baseline, six-week, 10-week, and 18- week follow-ups and throughout the 6-week intervention period.
|
|
Successful acquisition of study data
時間枠：Baseline, six-week, 10-week, and 18- week follow-ups and throughout the 6-week intervention period.
|
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.
|
Baseline, six-week, 10-week, and 18- week follow-ups and throughout the 6-week intervention period.
|
|
Box and Block Test (BBT) score
時間枠：Baseline, six-week follow-up, and 10-week follow-up. Keeping a 18-week follow-up as an exploratory time point.
|
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.
|
Baseline, six-week follow-up, and 10-week follow-up. Keeping a 18-week follow-up as an exploratory time point.
|
|
Modified Ashworth Scale (MAS) score
時間枠：Baseline, six-week follow-up, and 10-week follow-up. Keeping a 18-week follow-up as an exploratory time point.
|
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.
|
Baseline, six-week follow-up, and 10-week follow-up. Keeping a 18-week follow-up as an exploratory time point.
|
|
Wolf Motor Function Test (WMFT) score
時間枠：Baseline, six-week follow-up, and 10-week follow-up. Keeping a 18-week follow-up as an exploratory time point.
|
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.
|
Baseline, six-week follow-up, and 10-week follow-up. Keeping a 18-week follow-up as an exploratory time point.
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Jinsook Roh, PhD、University of Houston
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
便利なリンク
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2027年8月1日
一次修了 (推定)
2032年8月1日
研究の完了 (推定)
2032年8月1日
試験登録日
最初に提出
2025年10月22日
QC基準を満たした最初の提出物
2026年4月8日
最初の投稿 (実際)
2026年4月15日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月18日
QC基準を満たした最後の更新が送信されました
2026年6月15日
最終確認日
2026年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。