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临床试验/NCT07094360
NCT07094360已完成不适用

Effect of Hydrotherapy on Performance in Children With Brain Tumor

Cairo University0 个研究点目标入组 50 人开始时间: 2016年11月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
50
主要终点
Muscle strength of upper and lower limb muscles

研究概览

简要总结

  • Background: Brain and spinal cord tumors are the second most common cancers in children (after leukemia). They account for about 1 out of 4 childhood cancers. More than 4,000 central nervous system tumors are diagnosed each year in children and teens. (Blaney et al., 2011).
  • Aim: It has been reported that those children have easy fatigability so the purpose of this study is to investigate the effectiveness of hydrotherapy on endurance in these Children.
  • Significance: The effects of physical exercise training interventions for childhood cancer participants are not yet convincing due to small numbers of participants and insufficient study methodology. More and high-quality evidence is needed in order to be able to draft exercise and physical activity guidelines for this population. Despite the positive results of exercise interventions in adult cancer patients, the evidence for benefits in childhood cancer patients is limited (Braam et al., 2013).

An 8-week deep water exercise program was clinically effective for improving CRF(Cancer-Related-Fatigue), muscle strength, and several aspects of mood state as compared with usual treatment care at short and medium term in breast cancer survivors reporting a moderate rate of fatigue (Irene et al., 2013).

In this study, the investigators are trying to find out the effect of hydrotherapy as a way of fun and amusement that children can do easily with great pleasure and also as a treatment method.

  • Subjects: Thirty children of both sexes will participate in this study. Inclusion criteria: Children between 5-14 years old after brain tumor resection surgery 2 weeks post-surgery. Exclusion Criteria: Cognitive or mental (developmental), or both, impairment, Children with a genetic disorder, Children with a chronic lung disease, Severe cardiomyopathy (ejection fraction <40%, ischemia and angina pectoris at rest), Children with a neuromuscular disease.
  • Methodology:

For Evaluation: Lafayette manual muscle tester to assess muscle endurance/strength (Lafayette instrument evaluation, 2015). The pediatric quality of life inventory version 4(PedsQL) is used to assess quality of life (Varni et al., 1999). The nine-minute run-walk test (Guedes et al., 2006) and the timed up-and-down stairs test (Zaino et al., 2004) are to measure Cardiorespiratory fitness.

For Treatment: Children will be divided into two groups, control group will receive a land-exercise program and study group will receive the same exercise program then repetition of these exercises under water to study the effectiveness of using hydrotherapy. The program will take 30 minutes (5 minutes each with 1 minute rest in between).

The selected program will be in the form of:

  1. Sitting while strengthening shoulder horizontal adductors by using weights.
  2. Sitting while pushing down by using weights.
  3. Sitting while strengthening elbow extensors by using weights.
  4. Sitting while holding weights for a while.
  5. Standing on uneven surface.
  6. Pushing downs by legs.
  7. Sitting balance.
  8. Sitting with pushing by hands while making legs as glue.
  9. Sitting with kicking by legs while fixing hands.
  10. Standing and throwing a ball.
  11. Weight shifting and recovery while initiating single limb support.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
5 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • They will be selected according to the following criteria:
  • Children between 5-14 years old.
  • Children after brain tumor resection surgery 4 weeks post-surgery.

排除标准

  • Children who have one or more of the following criteria will be excluded from the study:
  • Children who cannot follow orders or instructions.
  • Children with a genetic disorder.
  • Children with a chronic lung disease.
  • Sever cardiomyopathy (ejection fraction <40%, ischemia and angina pectoris at rest).
  • Children with a neuromuscular disease.

结局指标

主要结局

Muscle strength of upper and lower limb muscles

时间窗: 4-6 months

Lafayette Manual Muscle Tester: The test was performed by applying force to the limb of a child as he/she resists the force isometrically. The objective of the test is for the clinician to overcome or "break" the child's resistance. When the resistance "break" occurs the Lafayette Manual Muscle Tester (MMT) records the peak force and the time required to achieve the "break providing reliable, accurate, and stable muscle strength readings that conform to most manual muscle testing protocols. The MMT also features a wide range of customizable options for data storage, preset test times, and force thresholds

次要结局

  • Pediatric quality of life(4-6 months)
  • Cardiorespiratory fitness(4-6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mahmoud Usama Mahmoud Ahmed

Lecturer at Pediatric department, Faculty of Physical Therapy, Cairo University.

Cairo University

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