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治験 NCT07049523（対象：脳性麻痺）は募集準備中です。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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Robotic Exoskeleton Gait Training for Children With Cerebral Palsy 36
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 NCT07049523 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 募集準備中 で、2025年10月1日 に開始予定です。36 名の参加者 の募集が計画されています。この試験は Hunan Normal University によって主導され、2027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7月8日 です。
概要
The goal of this clinical trial is to evaluate whether robotic-assisted gait training can improve motor function, walking capacity, joint flexibility, muscle structure, and psychological well-being in children aged 6 to 12 years with spastic cerebral palsy (CP) classified as Gross Motor Function Classification System (GMFCS) level IV.
The main questions it aims to answer are:
Can robotic gait training improve gross...
もっと見る詳細説明
Cerebral palsy (CP) remains the most common motor disability in childhood, affecting approximately 17 million people worldwide, with an estimated 2-3 per 1,000 live births. In China alone, the number of children with CP is estimated to exceed 6 million, with approximately 40,000 new cases occurring each year. Notably, a substantial proportion of these children are classified as Gross Motor Function Classification Sys...もっと見る
公式タイトル
Protocol for the "Stand the Future" Trial: Robotic Exoskeleton Gait Training for Non-Ambulatory Children With Spastic 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
- 2025-506
NCT番号
開始日
2025-10-01
最終更新日
2025-07-08
終了予定日
2027-03-01
目標参加者数
36
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集準備中
キーワード
fascicle length
muscle volume
motor development
gait
rehabilitation
muscle volume
motor development
gait
rehabilitation
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
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
非介入Regular rehabilitation Participants assigned to the regular rehabilitation (control) group will continue receiving their usual care as determined by their caregivers. Usual care may include activities such as home-based stretching, passive range-of-motion exercises, school-based physiotherapy, or outpatient therapy. There will be no restrictions on care choices. | 該当なし |
実験的Robotic-assisted gait training The intervention group will receive robotic-assisted gait training using the RoboCT Pediatric Lower Limb Rehabilitation Robot (RoboCT Limited Co., Hangzhou, China), a pediatric exoskeleton system designed for overground locomotor training. | Robotic-assisted gait training The intervention group will receive robotic-assisted gait training using the RoboCT Pediatric Lower Limb Rehabilitation Robot (RoboCT Limited Co., Hangzhou, China), a pediatric exoskeleton system designed for overground locomotor training. This device integrates real-time motion sensing, adaptive control algorithms, and customizable joint actuation to deliver precise and individualized gait training for children with...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 |
|---|---|---|
Gross Motor Function Measure - Item Set (GMFM-IS) | Gross motor function will be evaluated using the Gross Motor Function Measure - Item Set (GMFM-IS), a validated short-form tool derived from the full GMFM-66, appropriate for assessing changes in children with CP (Russell et al., 2010). It focuses on key motor tasks across five dimensions: lying and rolling, sitting, crawling and kneeling, standing, and walking, running, and jumping. In this study, trained evaluators will observe children as they perform selected motor tasks from the GMFM-IS. Each task will be scored on a 4-point ordinal scale: 0 = does not initiate; 1 = initiates (\<10% of the task); 2 = partially completes (10-99%); 3 = completes the task independently. The assessment will take place in a quiet, controlled environment with standardized instructions and safety precautions. Scores will be entered into the Gross Motor Ability Estimator software to generate interval-level total scores, allowing for sensitive tracking of changes in motor function over time. | Baseline (week 0), mid-point (week 12), and post-intervention (week 24) |
1-minute walk test | To assess functional walking capacity, participants will undergo the 1-minute walk test, performed on a marked 20-meter indoor course. Children will be instructed to walk as quickly and safely as possible without running, and the total distance covered in 60 seconds will be recorded. For participants who require orthoses or walkers, such assistive devices will be permitted during testing, consistent with real-world functionality. | Baseline (week 0), mid-point (week 12), and post-intervention (week 24) |
Passive ankle joint range of motion | Passive ankle joint range of motion (ROM) will be measured using an isokinetic dynamometer. Each child will be seated with the knee fully extended, the ankle joint aligned with the dynamometer's rotational axis, and the foot securely fixed to a footplate. Passive dorsiflexion and plantar flexion will be conducted through full available range to determine ROM and passive torque. | Baseline (week 0), mid-point (week 12), and post-intervention (week 24) |
Muscle morphological properties | Muscle morphological properties of the lower limbs will be assessed via ultrasonography using a 6-12 MHz linear transducer (Meinianda BX-5, Zibo, China). Images will be acquired for the rectus femoris, quadriceps femoris, and medial gastrocnemius on both lower limbs. Standardized anatomical landmarks will be used for probe placement, and muscle thickness and muscle fascicle length will be quantified offline by blinded assessors. | Baseline (week 0) and post-intervention (week 24) |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Pediatric Quality of Life Inventory | Psychological satisfaction and treatment engagement will be evaluated using the Pediatric Quality of Life Inventory (PedsQL™ 3.0 NMM), which is validated for children with chronic motor impairments (Iannaccone et al., 2009). This instrument includes child self-report and parent-proxy versions and assesses multiple dimensions including physical functioning, communication, and emotional well-being. Higher scores represent better perceived quality of life and satisfaction with daily function. | Baseline (week 0), mid-point (week 12), and post-intervention (week 24) |
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
6 Years
対象性別
全て
- No history of heart disease or family history of heart disease;
- Children classified as GMFCS level IV;
- Dependent on assistive mobility devices, such as wheelchairs or posture support walkers, for activities of daily living;
- Medically stable and able to sit upright for at least 30 minutes;
- Able to understand simple verbal or visual instructions.
- Aged under 6 years or over 12 years;
- Received botulinum toxin A injections for lower limb muscles within six months prior to baseline assessment;
- Implanted with an intrathecal baclofen pump, or has a history of lower limb-related orthopedic or neurosurgical interventions (such as tendon lengthening, osteotomy, or selective dorsal rhizotomy);
- Has uncontrolled epilepsy, severe cognitive impairment, or other comorbidities.
Hunan Normal University責任者
Yang Zhang, 主任研究者, Principle scientist, Hunan Normal University
試験中央連絡先
連絡先: Yang Zhang, PhD, 727-252-9687, [email protected]
連絡先: Dinghua Liu, MS, 8618807486231
位置情報がありません。