AID-FOG: Artificial Intelligence-Driven Freezing of Gait Detection in the Home (AID-FOG)
2026年5月5日 更新者：Moran Gilat、KU Leuven
Artificial Intelligence-Driven Freezing Of Gait Detection in the Home: Investigating How Free-living Activities Affect the Algorithm
Freezing of gait (FOG) is a debilitating symptom of Parkinson's disease increases the risk of falling.
Despite being a common symptom, it is still difficult to evaluate freezing of gait quickly and accurately.
Currently, the gold-standard method to determine the severity of FOG is a manual analysis of video footage by an experienced assessor, collected during standardized FOG-provoking walking tests.
Because this is a very time-intensive process, where different assessors sometimes obtain different results, our team at KU Leuven have developed an artificial-intelligent (AI) algorithm trained to identify FOG episodes based on wearable inertial measurement unit (IMU) sensor data.
The AI algorithm has already undergone initial validation during laboratory testing, yielding promising results.
The aim of this study is to investigate whether the AI algorithm can accurately detect FOG episodes in a less controlled environment, namely the home environment.
In a second phase, the investigators will also use the collected data to improve the AI algorithm for automated FOG detection in the home.
Finally, the investigators want to explore whether the AI algorithm can detect FOG in real-time.
調査の概要
状態
募集
研究の種類
観察的
入学 (推定)
126
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。
研究場所
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Tel Aviv、イスラエル、64
- まだ募集していません
- Center for the study of movement, cognition and mobility
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コンタクト：
- Jeffrey M Hausdorff
- 電話番号：+972-3-6973081
- メール：jhausdor@tlvmx.gov.il
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Hamburg、ドイツ、20457
- まだ募集していません
- Sports Science and Neurorehabilitation
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コンタクト：
- Christian Schlenstedt
- 電話番号：+4940.361 226 43206
- メール：christian.schlenstedt@medicalschool-hamburg.de
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Leuven、ベルギー、3001
- 募集
- Department of Rehabilitation Sciences
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コンタクト：
- Moran Gilat
- 電話番号：+3216 32 94 27
- メール：moran.gilat@kuleuven.be
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コンタクト：
- Margot Genbrugge
- 電話番号：+3216 19 44 94
- メール：margot.genbrugge@kuleuven.be
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主任研究者：
- Moran Gilat
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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
サンプリング方法
非確率サンプル
調査対象母集団
People with PD and healthy age-matched controls will be recruited from three primary sites, namely KU Leuven, Hamburg Medical Center, and Tel-Aviv Sourasky Medical Center.
説明
Inclusion Criteria:
For all participants
- Voluntary written informed consent of the participant has been obtained prior to any study-related procedures, except the non-recorded pre-screening questions;
- At least 18 years of age at the time of signing the Informed Consent Form (ICF);
- Person is cognitively able to follow and understand instructions and provide voluntary written informed consent;
- Person is able to walk for short distances (± 10 meters) independently, with- or without use of a walking aid;
- Person does not live in a temporary or permanent care facility.
For participants with PD:
- Clinical diagnosis of Parkinson's disease (PD) made by a neurologist according to the Movement Disorders Society guidelines;
- Person self-reports to experience daily FOG (for recruitment of freezers only);
- Person is willing to temporarily delay the morning anti-Parkinsonian medication during the standardized assessment visit.
Exclusion criteria:
- Occurrence of any of the following within 3 months prior to informed consent: myocardial infarction, hospitalization for unstable angina, stroke, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), implantation of a cardiac resynchronization therapy device (CRTD), active treatment for cancer or other malignant disease, uncontrolled congestive heart disease (NYHA class >3), acute psychosis or major psychiatric disorders or continued substance abuse, other neurological (than PD) or orthopaedic impairment that significantly impacts on gait;
- Participant self-reports daily falls;
- Participation in another interventional study, with or without an investigational medicinal product (IMP) or device (IMD)
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
コホートと介入
グループ/コホート |
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健康管理
健康な高齢者
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Freezers
Patients with Parkinson's disease who self-report to experience Freezing of Gait daily.
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Non-freezers
Patients with Parkinson's disease who do not experience Freezing of Gait.
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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 |
|---|---|---|
|
Comparing the agreement between AID-FOG and gold-standard expert annotation to detect the percentage of time spent with freezing of gait (FOG) in relation to total time duration (%TF).
時間枠：T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
|
The primary outcome (percentage of time spent with FOG in relation to total task duration = %TF) will be established by manual annotations of video footage by an experienced assessor (=gold-standard reference) and by the automated AID-FOG algorithm v1.0 applied post-hoc (i.e.
offline) to IMU data collected during the same walking tasks.
This will be calculated for standardized walking tasks on which the AID-FOG algorithm has been trained, standardized walking tasks on which the AID-FOG algorithm was not trained, and a free-living walking condition on which the AID-FOG algorithm was not trained.
|
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
F1-score
時間枠：T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
|
Same as primary outcome, but now for the F1-score (rather than percent TF).
F1 scores range between 0 and 1, the higher the score the better.
|
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
|
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Number of FOG episodes
時間枠：T0: free-living gait (5 hours), T1: free-living gait (5 hours) and T2: standardized gait (4 hours)
|
Same as primary outcome, but now for the absolute number of FOG episodes.
|
T0: free-living gait (5 hours), T1: free-living gait (5 hours) and T2: standardized gait (4 hours)
|
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The performance of the AID-FOG algorithm to differentiate between the FOG manifestations.
時間枠：T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
|
Freezing of gait (FOG) manifests in multiple forms, including akinetic and kinetic subtypes, which may be associated with trembling or occur without it.
This study investigates the performance of AID-FOG in discriminating between these manifestations, using expert annotations as the reference standard.
|
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
|
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Comparing performance of AID-FOG to detect freezing in OFF and ON medication states.
時間枠：T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
|
The FOG outcomes as obtained by the human expert and the offline AID-FOG algorithm v1.0 will be calculated for both the OFF and ON medication states.
These scores will be compared to evaluate the change in algorithm performance depending on medication status.
The FOG outcomes will be the percentage TF which ranges between 0-100 percent.
The higher the percentage the more freezing the patient has.
But also the F1-score which ranges between 0-1.
The higher the score the more overlap there is between the expert and the algorithm.
|
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
|
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Consistency of FOG detection with AID-FOG compared between two free-living assessments
時間枠：T0= test day 1: free-living gait (5 hours) and T1= test day 2: free-living gait (5 hours)
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The agreement in FOG detection (%TF, F1-score) between the AID-FOG algorithm and the gold-standard human annotations will be compared between the two free-living test days.
|
T0= test day 1: free-living gait (5 hours) and T1= test day 2: free-living gait (5 hours)
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The number of false detections of FOG episodes during free-living
時間枠：T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
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The absolute sum of false detections made by the algorithm.
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T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
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Comparing AID-FOG with subjective FOG
時間枠：T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
|
The FOG outcomes obtained with AID-FOG will be correlated to the total score of the New Freezing of Gait Questionnaire (NFOGQ) and Patient Reported Outcomes of FOG (PRO).
|
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
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Performance of automated FOG detection during free-living mobility
時間枠：1 week of free-living mobility with IMU
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The FOG outcomes obtained with AID-FOG offline will be calculated from multiple days of free-living mobility IMU data.
These outcomes will be correlated to FOG severity as determined during the observed walking tasks of the project and self-reported FOG severity.
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1 week of free-living mobility with IMU
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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AID-FOG version 2.0 (percentage TF)
時間枠：T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
|
The data obtained in the study will be used to train the AID-FOG algorithm v1.0. This trained AID-FOG algorithm v2.0 will be evaluated using the same listed outcome measures, using a leave-one-subject-out approach. Percentage of time spent with FOG in relation to total task duration (= %TF) will be established by manual annotations of video footage by an experienced assessor (=gold-standard reference) and by the automated AID-FOG algorithm v2.0 applied post-hoc (i.e. offline) to IMU data collected during the same walking tasks. This will be calculated for standardized walking tasks on which the AID-FOG algorithm has been trained, standardized walking tasks on which the AID-FOG algorithm was not trained, and a free-living walking condition on which the AID-FOG algorithm was not trained. |
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
|
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AID-FOG version 2.0 (F1-score)
時間枠：T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
|
The data obtained in the study will be used to train the AID-FOG algorithm v1.0.
This trained AID-FOG algorithm v2.0 will be evaluated using the same listed outcome measures, using a leave-one-subject-out approach.
Same as percentage TF, but now for the F1-score (rather than percent TF).
F1 scores range between 0 and 1, the higher the score the better.
|
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
|
|
AID-FOG version 2.0 (Number of FOG episodes)
時間枠：T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
|
The data obtained in the study will be used to train the AID-FOG algorithm v1.0.
This trained AID-FOG algorithm v2.0 will be evaluated using the same listed outcome measures, using a leave-one-subject-out approach.
Same as percentage TF, but now for the absolute number of FOG episodes.
|
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
|
|
AID-FOG version 2.0 (FOG manifestations)
時間枠：T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
|
The data obtained in the study will be used to train the AID-FOG algorithm v1.0.
This trained AID-FOG algorithm v2.0 will be evaluated using the same listed outcome measures, using a leave-one-subject-out approach.
The performance of the AID-FOG algorithm v2.0 to discriminate between the FOG manifestations.
Freezing of gait (FOG) manifests in multiple forms, including akinetic and kinetic subtypes, which may be associated with trembling or occur without it.
This study investigates the performance of AID-FOG in discriminating between these manifestations, using expert annotations as the reference standard.
|
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
|
|
AID-FOG version 2.0 (OFF/ON medication)
時間枠：T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
|
The data obtained in the study will be used to train the AID-FOG algorithm v1.0.
This trained AID-FOG algorithm v2.0 will be evaluated using the same listed outcome measures, using a leave-one-subject-out approach.
Comparing performance of AID-FOG v2.0 to detect freezing in OFF and ON medication states.
The FOG outcomes as obtained by the human expert and the offline AID-FOG algorithm v2.0 will be calculated for both the OFF and ON medication states.
These scores will be compared to evaluate the change in algorithm performance depending on medication status.
The FOG outcomes will be the percentage TF which ranges between 0-100 percent.
The higher the percentage the more freezing the patient has.
But also the F1-score which ranges between 0-1.
The higher the score the more overlap there is between the expert and the algorithm.
|
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
|
|
AID-FOG version 2.0 (consistency of detection during two free-living assessments)
時間枠：T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
|
The data obtained in the study will be used to train the AID-FOG algorithm v1.0.
This trained AID-FOG algorithm v2.0 will be evaluated using the same listed outcome measures, using a leave-one-subject-out approach.
Consistency of FOG detection with AID-FOG v2.0 compared between two free-living assessments.
The agreement in FOG detection (%TF, F1-score) between the AID-FOG algorithm v2.0 and the gold-standard human annotations will be compared between the two free-living test days.
|
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
|
|
AID-FOG version 2.0 (number of false positives)
時間枠：T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
|
The data obtained in the study will be used to train the AID-FOG algorithm v1.0.
This trained AID-FOG algorithm v2.0 will be evaluated using the same listed outcome measures, using a leave-one-subject-out approach.
The number of false detections (AID-FOG v2.0) of FOG episodes during free-living
|
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
|
|
AID-FOG version 2.0 (subjective FOG)
時間枠：T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
|
The data obtained in the study will be used to train the AID-FOG algorithm v1.0.
This trained AID-FOG algorithm v2.0 will be evaluated using the same listed outcome measures, using a leave-one-subject-out approach.
Comparing AID-FOG v2.0 with subjective FOG.
The FOG outcomes obtained with AID-FOG v2.0 will be correlated to the total score of the New Freezing of Gait Questionnaire (NFOGQ) and Patient Reported Outcomes of FOG (PRO).
|
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
|
|
AID-FOG online (percentage TF)
時間枠：T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
|
The AID-FOG algorithm will be modified for real-time FOG detection.
Performance of this AID-FOG online algorithm will be compared with AID-FOG offline versions, using the same listed outcomes.
Percentage of time spent with FOG in relation to total task duration (= %TF) will be established by manual annotations of video footage by an experienced assessor (=gold-standard reference) and by the automated AID-FOG online to IMU data collected during the same walking tasks.
This will be calculated for standardized walking tasks on which the AID-FOG algorithm has been trained, standardized walking tasks on which the AID-FOG algorithm was not trained, and a free-living walking condition on which the AID-FOG algorithm was not trained.
|
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
|
|
AID-FOG online (F1-score)
時間枠：T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
|
The AID-FOG algorithm will be modified for real-time FOG detection.
Performance of this AID-FOG online algorithm will be compared with AID-FOG offline versions, using the same listed outcomes.
Same as percentage TF, but now for the F1-score (rather than percent TF).
F1 scores range between 0 and 1, the higher the score the better.
|
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
|
|
AID-FOG online (number of FOG episodes)
時間枠：T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
|
The AID-FOG algorithm will be modified for real-time FOG detection.
Performance of this AID-FOG online algorithm will be compared with AID-FOG offline versions, using the same listed outcomes.
Same as percentage TF, but now for the absolute number of FOG episodes.
|
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
|
|
AID-FOG online (FOG manifestations)
時間枠：T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
|
The AID-FOG algorithm will be modified for real-time FOG detection.
Performance of this AID-FOG online algorithm will be compared with AID-FOG offline versions, using the same listed outcomes.
The performance of the AID-FOG online algorithm to discriminate between the FOG manifestations.
|
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
|
|
AID-FOG online (OFF/ON medication)
時間枠：T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
|
The AID-FOG algorithm will be modified for real-time FOG detection.
Performance of this AID-FOG online algorithm will be compared with AID-FOG offline versions, using the same listed outcomes.
The FOG outcomes as obtained by the human expert and the offline AID-FOG online algorithm will be calculated for both the OFF and ON medication states.
These scores will be compared to evaluate the change in algorithm performance depending on medication status.
The FOG outcomes will be the percentage TF which ranges between 0-100 percent.
The higher the percentage the more freezing the patient has.
But also the F1-score which ranges between 0-1.
The higher the score the more overlap there is between the expert and the algorithm.
|
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
|
|
AID-FOG online (agreement of the detection between two free-living test days)
時間枠：T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
|
The AID-FOG algorithm will be modified for real-time FOG detection.
Performance of this AID-FOG online algorithm will be compared with AID-FOG offline versions, using the same listed outcomes.
The agreement in FOG detection (%TF, F1-score) between the AID-FOG online algorithm and the gold-standard human annotations will be compared between the two free-living test days.
|
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
|
|
AID-FOG online (number false positives)
時間枠：T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
|
The AID-FOG algorithm will be modified for real-time FOG detection.
Performance of this AID-FOG online algorithm will be compared with AID-FOG offline versions, using the same listed outcomes.
The absolute sum of false detections made by the online algorithm.
|
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
|
|
AID-FOG online (subjective FOG)
時間枠：T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
|
The AID-FOG algorithm will be modified for real-time FOG detection.
Performance of this AID-FOG online algorithm will be compared with AID-FOG offline versions, using the same listed outcomes.
Comparing AID-FOG online with subjective FOG.
The FOG outcomes obtained with AID-FOG online will be correlated to the total score of the New Freezing of Gait Questionnaire (NFOGQ) and Patient Reported Outcomes of FOG (PRO).
|
T0=test day 1: free-living gait assessment (5 hours), T1=test day 2: free-living gait (5 hours) and T2= test day 3: standardized gait (4 hours)
|
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。
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
- Yang PK, Filtjens B, Ginis P, Goris M, Nieuwboer A, Gilat M, Slaets P, Vanrumste B. Freezing of gait assessment with inertial measurement units and deep learning: effect of tasks, medication states, and stops. J Neuroeng Rehabil. 2024 Feb 13;21(1):24. doi: 10.1186/s12984-024-01320-1.
- Yang PK, Filtjens B, Ginis P, Goris M, Nieuwboer A, Gilat M, Slaets P, Vanrumste B. Automatic Detection and Assessment of Freezing of Gait Manifestations. IEEE Trans Neural Syst Rehabil Eng. 2024;32:2699-2708. doi: 10.1109/TNSRE.2024.3431208. Epub 2024 Jul 31.
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 (実際)
2025年9月22日
一次修了 (推定)
2027年6月1日
研究の完了 (推定)
2027年6月1日
試験登録日
最初に提出
2026年4月2日
QC基準を満たした最初の提出物
2026年5月5日
最初の投稿 (実際)
2026年5月12日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月12日
QC基準を満たした最後の更新が送信されました
2026年5月5日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- S70220
- MJFF-024628 (その他の助成金/資金番号：Micheal J. Fox)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
IPD プランの説明
The datasets could be made available under restricted access after publication of the results, following ethical approval and a data-transfer agreement.
GDPR and privacy regulations will be adhered to.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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。