パテロフェムラル疼痛症候群の患者における多学科デジタル治療法の安全性と有効性を評価するための予期的なランダム化制御臨床試験のための試験プロトコル
Tae Hyun Park1, Chan Yoon1, Jae Hyeon Park2
1EverEx Inc, 10, Gangnam-daero 94-gil, Gangnam-gu, Seoul, Korea.
Trials
|September 2, 2025
まとめ
新しいデジタル治療アプリであるMORA Cure PFPは 運動と認知行動療法を組み合わせて 膝関節の痛みを改善することを目指しています この試験では,膝の痛みを和らげるための標準治療に対する効果を評価します.
科学分野:
- 整形外科
- デジタル・セラピー
- リハビリテーション医学
背景:
- 膝関節痛は 患者の40%まで,特に 10歳から50歳の女性に影響します.
- 慣習的な治療法である運動療法が 長期的に有効性が限られているのは 適応能力の低下や 心理的要因によるものです
- デジタルセラピーは これらの限界を克服する 新しいアプローチを提供します
研究 の 目的:
- MORA Cure PFPの安全性と有効性を評価する.
- このアプリの効果と 自律的な運動の効果を 比較するためです
主な方法:
- 2つの腕による制御試験では 膝関節痛の患者216人が登録されます.
- 参加者は1対1でランダムにMORA Cure PFPアプリを使用するか,自己指導運動を実行します.
- 2次評価には,膝の機能と心理的要因が含まれています.
主要な成果:
- このセクションは,提供された概要には含まれていません.
結論:
- 医療機器としてのソフトウェアの医療,規制,医療技術評価の側面を考慮した臨床試験の設計.
- 主要な要素には,対照群の選択,患者基準,サンプルサイズ,およびプライマリエンドポイントの決定が含まれます.
関連する概念動画
Blind Procedures
10.8K
Ideally, the people who observe and record the children’s behavior are unaware of who was assigned to the experimental or control group, in order to control for experimenter bias. Experimenter bias refers to the possibility that a researcher’s expectations might skew the results of the study. Remember, conducting an experiment requires a lot of planning, and the people involved in the research project have a vested interest in supporting their hypotheses. If the observers knew which...
10.8K
Clinical Trials
8.5K
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
There are four phases in a clinical trial. A phase one...
8.5K
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
627
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
627
Bioavailability Study Design: Single Versus Multiple Dose Studies
383
Bioavailability studies are essential for understanding how a drug is absorbed, distributed, metabolized, and excreted in the body. These studies assess the extent and rate at which the active pharmaceutical agent becomes available at the site of action. The design of bioavailability studies can involve single-dose or multiple-dose regimens, each with distinct advantages and limitations.Single-dose studies are the preferred approach due to their simplicity and reduced drug exposure for...
383
Bioavailability Study Design: Healthy Subjects Versus Patients
248
Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
248
Hazard Ratio
756
The hazard ratio (HR) is a widely used measure in clinical trials to compare the risk of events, such as death or disease recurrence, between two groups over time. It reflects the ratio of hazard rates—the instantaneous risk of the event occurring—between a treatment group and a control group. This measure provides valuable insights into the relative effectiveness of a treatment by assessing how the risk of an event differs between the two groups.
For example, in a clinical trial...
For example, in a clinical trial...
756


