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临床试验 NCT05649930 (MegaMuscle) 针对痉挛性脑瘫目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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Effect of Functional Power Training on Calf Muscle Length and Strength in Children With Spastic Paresis (MegaMuscle) 23
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临床试验NCT05649930 (MegaMuscle)是一项针对痉挛性脑瘫的观察研究试验，目前试验状态为招募中。试验始于2022年6月20日，计划招募23名患者。该研究由Amsterdam UMC, location VUmc主导，预计于2025年9月30日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年1月8日。
简要概括
Spastic paresis (SP) is a common motor condition in children and is often caused by cerebral palsy. Skeletal muscles develop differently in children with SP due to brain damage in early development; muscle strength and muscle length are reduced compared to typically developing (TD) children. Especially, the calf muscles are affected, which particularly affects their ability to walk and to run, hindering participation...显示更多
官方标题
Effect of Functional Power Training on Muscle Morphology and Strength of the Medial Gastrocnemius in Children With Spastic Paresis
疾病
痉挛性脑瘫其他研究标识符
- MegaMuscle
- 2021015 (其他拨款/资助编号) (Phelps stichting voor spastici)
- 20210088 (其他拨款/资助编号) (JKF/KFA)
- AMS-2021-Innovatiecall-P5 (其他拨款/资助编号) (Amsterdam Movement Sciences)
NCT编号
实际开始日期
2022-06-20
最近更新发布
2025-01-08
预计完成日期
2025-09-30
计划入组人数
23
研究类型
观察研究
试验状态
招募中
关键词
Medial gastrocnemius morphology
3D ultrasonography
Functional power training
3D ultrasonography
Functional power training
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
Spastic paresis Children with spastic paresis | Functional power training The training consists of weighted running and walking exercises performed at high-velocity and is given three times a week for 12 weeks. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Muscle volume in dm^3 | 12 weeks before start training (week -12) | |
Muscle volume in dm^3 | At the start of training (week 0) | |
Muscle volume in dm^3 | At the end of the training (week 12) | |
Muscle belly length in mm | 12 weeks before start training (week -12) | |
Muscle belly length in mm | At the start of training (week 0) | |
Muscle belly length in mm | At the end of the training (week 12) | |
Tendon length in mm | 12 weeks before start training (week -12) | |
Tendon length in mm | At the start of training (week 0) | |
Tendon length in mm | At the end of the training (week 12) | |
Fascicle length in mm | 12 weeks before start training (week -12) | |
Fascicle length in mm | At the start of training (week 0) | |
Fascicle length in mm | At the end of the training (week 12) |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Isometric muscle strength of the medial gastrocnemius | Measured with a hand-held dynamometer in Nm. | At the start of training (week 0) |
Isometric muscle strength of the medial gastrocnemius | Measured with a hand-held dynamometer in Nm. | At the end of the training (week 12) |
Dynamic muscle strength | Standing heel-rise test on one leg. Measured in amount of repetitions. | At the start of training (week 0) |
Dynamic muscle strength | Standing heel-rise test on one leg. Measured in amount of repetitions. | At the end of the training (week 12) |
Functional Strength Measure (FSM) | Measurement for lower and upper limb functionality. | At the start of training (week 0) |
Functional Strength Measure (FSM) | Measurement for lower and upper limb functionality. | At the end of the training (week 12) |
1-minute-walk-test | Distance (m) covered in 1 min walking. | At the start of training (week 0) |
1-minute-walk-test | Distance (m) covered in 1 min walking. | At the end of the training (week 12) |
10m Shuttle run test | Measured in amount of steps reached. | At the start of training (week 0) |
10m Shuttle run test | Measured in amount of steps reached. | At the end of the training (week 12) |
6x15m sprint | Measured as average time (s) over 6x15 m sprint. | At the start of training (week 0) |
6x15m sprint | Measured as average time (s) over 6x15 m sprint. | At the end of the training (week 12) |
Ankle range of motion | Maximal dorsiflexion in degrees manually measured with a goniometer. | At the start of training (week 0) |
Ankle range of motion | Maximal dorsiflexion in degrees manually measured with a goniometer. | At the end of the training (week 12) |
Body weight in kg | 12 weeks before start training (week -12) | |
Body weight in kg | At the start of training (week 0) | |
Body weight in kg | At the end of the training (week 12) | |
Body length in m | 12 weeks before start training (week -12) | |
Body length in m | At the start of training (week 0) | |
Body length in m | At the end of the training (week 12) | |
Lower leg length in mm | Measured from the lateral malleolus and tibial plateau. | 12 weeks before start training (week -12) |
Lower leg length in mm | Measured from the lateral malleolus and tibial plateau. | At the start of training (week 0) |
Lower leg length in mm | Measured from the lateral malleolus and tibial plateau. | At the end of the training (week 12) |
参与助手
资格标准
适龄参与研究
儿童, 成人
最低年龄要求
4 Years
适龄性别
全部
- Gross Motor Function Classification System I-III
- Children should be able to lie on their stomach for min. one minute
- Children should be able to follow instructions.
- Received (one of) the following interventions within six months:
- Casting
- Botulinum toxin type-A injections
- Orthopedic surgery.
Amsterdam UMC, location VUmc- Reade Rheumatology Research Institute
- 根特大学282 个活跃的临床试验可供探索
研究责任方
Babette Mooijekind, 主要研究者, Coordinating Investigator, Amsterdam UMC, location VUmc
研究中心联系人
联系人: Marjolein M van der Krogt, Dr., (20)4440789, [email protected]
1 位于 1 个国家/地区的研究中心
Reade, Amsterdam, 1056 AB, Netherlands
招募中