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治験 NCT06840626（対象：脳性麻痺）は実施中／登録終了です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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Pilot Study on Breathing Exercises and Pulmonary Function in Children With Cerebral Palsy: A Randomized Trial 55 無作為化 小児 運動療法
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT06840626 は 介入研究 臨床試験 で、脳性麻痺 に関するものです。現在は 実施中／登録終了 で、2024年4月15日 から開始しています。55 名の参加者 の募集が計画されています。この試験は Semmelweis University によって主導され、2025年3月30日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年2月21日 です。
概要
This pilot study is a randomized controlled trial aimed at investigating the efficacy of protocolized conductive breathing exercises combined with regular air ventilation, in addition to standard care, on various aspects of health in school-aged children with cerebral palsy (CP). The primary objectives of the study include assessing the effects on pulmonary functions, quality of life (QoL), depression anxiety and str...もっと見る
公式タイトル
Pilot Study on the Effects of Conductive Breathing Exercises on Pulmonary Function in School-Aged Children With Cerebral Palsy: A Randomized Controlled Trial
疾患名
脳性麻痺その他の研究識別子
- SE11568780
NCT番号
開始日
2024-04-15
最終更新日
2025-02-21
終了予定日
2025-03-30
目標参加者数
55
試験の種類
介入研究
治験の相・段階
該当なし
状況
実施中／登録終了
キーワード
cerebral palsy
respiratory health
spirometry
CP quality of life
respiratory health
spirometry
CP quality of life
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
二重盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Intervention Arm In this group, participants received conductive education as standard rehabilitation care plus the procolized breathing exercesis. In this group, participants followed a strict protocol for breathing exercises over an 8-week period, performing them three times a day, Monday through Friday, for five minutes each session. They also adhered to prescribed ventilation guidelines, in addition to receiving standard rehabili...もっと見る | Series of breathing exercises During the intervention, participants perform respiratory exercises, including deep breathing, belly breathing, exhalation with vocalization, and forced exhalation. Each exercise is repeated five times, three times per day: twice in the morning and once in the afternoon. The exercises are conducted in a seated, corrected position, guided by rehabilitation specialists or special needs teachers who provide instructions...もっと見る |
非介入Control Arm In this group, participants received conductive education as standard rehabilitation care plus sham breathing exercises. Participants in this group followed a strict 8-week protocol for breathing exercises, which included a sham breathing protocol, performing the exercises three times a day, Monday through Friday, for one minutes each session. | 該当なし |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Forced Expiratory Volume in 1st second (FEV1) in (L) | Change from baseline in forced expiratory volume in 1st second (FEV1)
* Description: FEV1 is the maximal volume of air that can be expired in the first second of forced vital capacity maneuver using spirometry.
* Units of Measure: L (Liter) | • Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks |
Forced Expiratory Volume in 1st second (FEV1) in % | Change from baseline in forced expiratory volume in 1st second (FEV1)
• Units of Measure: Percentage (%) The mentioned outcome will be measured using a spirometer and calculated according to the Quanjer, 1993 (ECCS) standards. | Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks |
Forced Vital Capacity (FVC) in (L) | * Description: FVC is the maximal volume of air that can be forcefully exhaled after taking the deepest breath possible, measured using spirometry.
* Units of Measure: L (Liter) | Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks |
Forced Vital Capacity (FVC) in % | FVC is the maximal volume of air that can be forcefully exhaled after taking the deepest breath possible, measured using spirometry.
• Units of Measure: Percentage (%)
The mentioned outcome will be measured using a spirometer and calculated according to the Quanjer, 1993 (ECCS) standards: | Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks |
FEV1/FVC Ratio | Description: This is already a combined measurement (a ratio of Forced Expiratory Volume in the first second to Forced Vital Capacity).
No unit. | Measured at 0, 8, and 18 weeks. |
Peak Expiratory Flow (PEF) in (L/sec) | Description: Peak Expiratory Flow (PEF) is the highest speed at which air can be forcefully exhaled from the lungs after taking the deepest breath possible, measured using spirometry.
Units of Measure: L/sec (Liter/secundum) | Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks |
Peak Expiratory Flow (PEF) in % | Description: Peak Expiratory Flow (PEF) is the highest speed at which air can be forcefully exhaled from the lungs after taking the deepest breath possible, measured using spirometry. • Units of Measure: Percentage (%) The mentioned outcome will be measured using a spirometer and calculated according to the Quanjer, 1993 (ECCS) standards. | Time Frame: Measurement at 0 weeks, 8 weeks, and 18 weeks |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Cerebral Palsy Quality of Life | The CP QoL test measures changes in quality of life (QoL) across different domains, such as social and emotional well-being, acceptance, bodily pain, and functioning. The assessment is conducted at three time points: 0 weeks, 8 weeks, and 18 weeks.
Scoring and Interpretation:
Scale: Scores are recorded from 1 to 9, where 1 = Very unhappy and 9 = Very happy. Higher scores indicate better quality of life (QoL). | measurement at 0 weeks, 8 weeks, 18 weeks |
Severity and Frequency of Drooling | The severity and frequency of drooling will be assessed for changes. | measurement at 0 weeks, 8 weeks, 18 weeks |
Depression level | Depression Scale (DAS-D): Measures symptoms of depression such as low mood, hopelessness, and loss of interest.
• Scale Details:
* Minimum Score: \[0\]
* Maximum Score: \[28\]
In this scale, higher scores represent worse outcomes (indicating more severe depression symptoms), while lower scores reflect better mental health (indicating fewer or less severe symptoms of depression). | measurement at 0 weeks, 8 weeks, 18 weeks |
Anxiety level | Anxiety Scale (DAS-A): Assesses symptoms related to anxiety, including nervousness, panic, and fear.
Scale Details:
* Minimum Score: \[0\]
* Maximum Score: \[20\] In this scale, higher scores represent worse outcomes (indicating more severe anxiety symptoms), while lower scores reflect better mental health (indicating fewer or less severe symptoms of anxiety). | measurement at 0 weeks, 8 weeks, 18 weeks |
Stress level | Stress Scale (DAS-S): Evaluates stress-related symptoms like irritability, tension, and difficulty relaxing.
Scale Details:
* Minimum Score: \[0\]
* Maximum Score: \[34\] In this scale, higher scores represent worse outcomes (indicating more severe stress symptoms), while lower scores reflect better mental health (indicating fewer or less severe symptoms of stress). | measurement at 0 weeks, 8 weeks, 18 weeks |
Eating Ability | Measured with EDACS test, changes in Eating and Drinking Ability, encompassing oral-motor skills, pharyngeal function, eating skills, and drinking skills. It assesses the coordination of mouth, tongue, and jaw movements, swallowing function, food preparation, grasping, and consumption of both food and liquids. | measurement at 0 weeks, 8 weeks, 18 weeks |
Drinking Ability | Measured with EDACS test, changes in Eating and Drinking Ability, encompassing oral-motor skills, pharyngeal function, eating skills, and drinking skills. It assesses the coordination of mouth, tongue, and jaw movements, swallowing function, food preparation, grasping, and consumption of both food and liquids. | measurement at 0 weeks, 8 weeks, 18 weeks |
参加アシスタント
適格基準
対象年齢
小児, 成人
試験の最低年齢
12 Years
対象性別
全て
- Children with cerebral palsy (GMFCS I-V)
- School-Aged 12-22 years, of both genders
- Teens and adolescents attending continuous standard care
- Capable of understanding and following commands given by the therapist
- Children who do not require respiratory support
- Children who have received recent surgical procedures or botulinum toxin injections
- Children who are unable to perform spirometry
Semmelweis UniversityCenter for Translational Medicine連絡先情報がありません。
1 1カ国の場所
Pest County
Semmelweis University, Conductive Pedagogical Methodology Institution and College., Budapest, Pest County, 1125, Hungary