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治験 NCT06100562(対象:脳性麻痺)は募集中です。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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Dance Program for Youth With Cerebral Palsy 20 アダプティブ
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 NCT06100562 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 募集中 で、2024年1月22日 から開始しています。20 名の参加者 の募集が計画されています。この試験は Texas Scottish Rite Hospital for Children によって主導され、2027年8月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年9月8日 です。
概要
The goal of this prospective cohort study is to learn about the impact of an adapted dance program in youth with cerebral palsy. The main questions it aims to answer are:
- Are there clinically significant benefits for children with cerebral palsy who participate in an Adaptive Dance Program?
- Is it feasible to implement an adaptive dance program using action-observation principles for children diagnosed with Cer...
詳細説明
Purpose:
Cerebral palsy (CP) is defined as a group of permanent disorders of the development of movement and posture that are attributed to non-progressive disturbances which occurred in the developing fetal or infant brain. As children with CP experience development and growth, motor disorders present along with disorders related to sensation, perception, cognition, and/or a seizure disorder. The way that CP manife...
もっと見る公式タイトル
Dance Program for Youth With Cerebral Palsy
疾患名
脳性麻痺刊行物
この臨床試験について発表された科学記事と研究論文:その他の研究識別子
- STU-2023-0893
NCT番号
開始日
2024-01-22
最終更新日
2025-09-08
終了予定日
2027-08
目標参加者数
20
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集中
キーワード
Dance
Action Observation
Action Observation
主目的
治療
割付方法
該当なし
介入モデル
単一群割当
盲検化
なし(非盲検)
群(アーム)/介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Dance Program 10-week adapted dance program (20 hours) | Adapted Dance Program * Participants will attend a 2x/weekly adaptive dance session for 10 weeks. If participants miss a class due to illness or an unexpected event (loss of transportation, family emergency/need) they will receive a video of the content missed and can complete the session at home.
* Each class will start with a 10 min warm-up that will include stretching and motor games.
* Learn a section of choreography every session usi...もっと見る |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Pediatric Balance Scale (PBS) | a 14-item criterion referenced measure that tests functional balance for pediatric patients in everyday tasks with a sum score of 0-56. A higher score represents better balance. | within 2 weeks of start of intervention (pre-intervention), within 2 weeks of end of intervention (post-intervention) |
6 minute walk test (6MWT) | a standardized, self-paced walking test that is used to measure functional ability; the score is the amount of meters walked in 6 minutes; longer distances walked represents better function | within 2 weeks of start of intervention (pre-intervention), within 2 weeks of end of intervention (post-intervention) |
The Cerebral Palsy Quality of Life Questionnaire (CPQOL) | a standardized patient reported outcome measure that measures quality of life; it is completed by the caregiver and by children with CP ages 9+; each item is rated on a scale from 1-9, higher ratings indicate better quality of life | within 2 weeks of start of intervention (pre-intervention), within 2 weeks of end of intervention (post-intervention) |
Child and Adolescent Scale of Participation (CASP) | 20-item caregiver questionnaire that measures a child or adolescent's participation in home, school, and community with a sum score of 20-80; a higher score represents higher participation | within 2 weeks of start of intervention (pre-intervention), within 2 weeks of end of intervention (post-intervention) |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Modified Ashworth Scale (MAS) | standardized measurement of tone on a 5 point scale (0, 1, 1+, 2, 3); a higher score represents increased tone | within 2 weeks of start of intervention (pre-intervention), within 2 weeks of end of intervention (post-intervention) |
Quality of Upper Limb Extremity Skills Test (QUEST) (optional) | standardized, criterion-referenced assessment that measures dissociated movement, grasp, protective extension, and weight bearing that is reported using a standard score ranging from 0-100. A higher score represents better upper limb function. | within 2 weeks of start of intervention (pre-intervention), within 2 weeks of end of intervention (post-intervention) |
Bruininks-Oseretsky Test of Motor Proficiency (BOT-2) -subsections (bilateral coordination and upper limb coordination) (optional) | standardized, norm-referenced assessment that measures fine and gross motor skills; subtests are scored using scaled scores with a mean of 15 and standard deviation of 5. A higher score represents higher motor performance. | within 2 weeks of start of intervention (pre-intervention), within 2 weeks of end of intervention (post-intervention) |
参加アシスタント
適格基準
対象年齢
小児
試験の最低年齢
4 Years
対象性別
全て
- Diagnosis of cerebral palsy
- GMFCS levels 1 or 2
- MACS levels 1-3
- Aged 4-17 years
- Able to follow directions in English
- Ability to complete the assessment protocol
- Does not have any restrictions/contraindications following a medical procedure that prohibits movement
- has uncontrolled epilepsy
- has severe behavioral problems
- unable to complete the assessment protocol
試験中央連絡先
連絡先: Angela Shierk, PhD, (469) 412-7172, [email protected]
1 1カ国の場所
Texas
Scottish Rite for Children, Frisco, Texas, 75034, United States
Angela Shierk, PhD, 連絡先, 469-412-7172, [email protected]
募集中