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治験 NCT06852664 (Fitbit)（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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Improving Activity in Individuals With Cerebral Palsy (Fitbit) 32 ウェアラブル
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 NCT06852664 (Fitbit) 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、2025年3月1日 から開始しています。32 名の参加者 の募集が計画されています。この試験は Father Flanagan's Boys' Home によって主導され、2029年3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29日 です。
概要
Individuals with cerebral palsy are known to have a reduced amount of physical activity; yet, there are no known intervention strategies for improving the number of steps they take each day. This study will use wearable physical activity monitors to assess if behavioral coaching is a viable strategy for combating the reduced physical activity seen in this patient population.
詳細説明
A lack of physical activity in persons with cerebral palsy is known to have cascading effects on their overall health. Despite this recognition, there have been limited attempts to improve the physical activity of this patient population. The overall landscape of this project is that a cohort of persons with cerebral palsy will undergo 8 weeks of physical activity that is guided by behavioral coaching. This study aim...もっと見る
公式タイトル
Improving Activity in Individuals With Cerebral Palsy
疾患名
脳性麻痺その他の研究識別子
- Fitbit
- 24-23-XP
NCT番号
開始日
2025-03-01
最終更新日
2025-09-29
終了予定日
2029-03-01
目標参加者数
32
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
Cerebral Palsy
Fitbit
Mobility
Steps
Fitbit
Mobility
Steps
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Cerebral Palsy Youth/Young Adults Baseline and 8-week assessments as well as 8 weeks of motivational interviewing 3x/week | 動機付け面接 The participants will meet with the research staff three times a week during the eight weeks of wearing the activity monitor via video or Webex call with a duration ideally not exceeding one hour. All staff involved in these coaching sessions have been MINT trained and certified and have mastered the skills of motivational interviewing. Their goal will be to discuss with the participant about how successful they have...もっと見る |
主要評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Change in Mobility Test Time | The participant will be asked to perform a series of 10-meter walking tasks such as walking at preferred speed, walking as fast as possible, walking while turning the head, walking around cones, and stepping over a box. The participant will also be asked to walk as far as possible for 1 minute. Completion time will be the primary outcome for these tests. Additionally, the tests will also be digitally video-recorded and scored by an independent assessor. | Baseline and 8 weeks |
Change in Time in 5 Times Sit-to-Stand | The participant will start the test by sitting on a bench. The time it takes to stand up and sit down five times will be the outcome measure. | Baseline and 8 weeks |
Change in Time for Timed Up and Go | The participant will start the test by sitting on a bench. The time it takes the participant to stand-up, walk to a line on the floor that is 3-meters away and return to sitting on the bench will be the outcome measure. | Baseline and 8 weeks |
Changes in Brain Activity | Magnetoencephalography (MEG) will be used to assess the changes in the cortical activity while producing a leg motor action and processing peripheral sensations. | Baseline and 8 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
11 Years
対象性別
全て
- Cerebral palsy diagnosis and ambulatory (Gross Motor Function Classification Score \[GMFCS\] levels between I-III).
- No orthopedic surgery in the last 6 months, botulinum injections within the last 6 months, or metal in their body that would preclude the use of MEG.
Father Flanagan's Boys' Home責任者
Max Kurz, 主任研究者, Director of PoWER Lab, Father Flanagan's Boys' Home
試験中央連絡先
連絡先: Max J Kurz, PhD, 531-355-8924, [email protected]
連絡先: Jennifer M Kime, MS, 531-355-8959, [email protected]
1 1カ国の場所
Nebraska
Boys Town National Research Hospital, Boys Town, Nebraska, 68010, United States
Max J Kurz, PhD, 連絡先, 402-559-6415, [email protected]
Max J Kurz, PhD, 主任研究者
募集中