跳至主要内容
临床试验/NCT07069946
NCT07069946尚未招募不适用

Effect of Weight Bearing Exercises With Neuromuscular Electrical Stimulation on Balance and Functional Abilities In Children With Hemiplegia

Cairo University0 个研究点目标入组 30 人开始时间: 2025年7月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
主要终点
Balance

研究概览

简要总结

This study will be conducted to investigate the combining effect of weight-bearing exercises program with neuromuscular electrical stimulation on balance and functional abilities in children with hemiplegic cerebral palsy.

详细描述

Hemiplegic cerebral palsy (HCP) is characterized by unilateral motor impairment, with the upper extremities typically exhibiting greater functional limitations compared to the lower limbs. This subtype constitutes approximately 20-30% of cerebral palsy cases and arises from unilateral injury to the developing brain, resulting in asymmetrical muscle tone abnormalities, joint deformities, and restricted range of motion. Individuals with HCP often display irregular, uncoordinated movements on the affected side, significantly impacting motor performance. Children with spastic hemiplegia experience decreased balance ability and abnormal gait because of decreased weight-bearing in the paretic leg. Diminished motor ability in the paretic leg causes weakening of the quadriceps, ankle plantar flexors, and ankle dorsiflexors.

The rehabilitation of balance and walking ability is crucial for children diagnosed with cerebral palsy. Weight-bearing exercises are defined as physical activities in which the feet and legs support the body's weight while moving against gravity. These exercises are essential for stimulating bone growth, improving bone density, and enhancing musculoskeletal health. Examples of weight-bearing exercises include walking, running, jumping, dancing, climbing stairs, playing sports such as soccer or basketball, and engaging in recreational activities like hiking or skating. Regular participation in weight-bearing exercises is particularly important for children and adolescents, as it helps maximize peak bone mass during growth and reduces the risk of osteoporosis later in life.

Exercise programs for cerebral palsy exhibit significant variation in terms of their types, such as gait training, body-weight-supported treadmill training, balance training, or multi-component approaches, and the efficacy of different exercises has not been established in improving the functional abilities of children with cerebral palsy. Studies suggest that integrating neuromuscular electrical stimulation (NMES) with conventional rehabilitation approaches enhances therapeutic outcomes compared to using NMES in isolation .

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
Single (Outcomes Assessor)

盲法说明

sealed envelopes

入排标准

年龄范围
6 Years 至 10 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Children diagnosed with hemiplegic cerebral palsy.
  • •Their age will range from 6-10 years.
  • •Both sexes will be included.
  • •All participants will be able to follow simple commands.
  • •They will be graded as mild spasticity of the lower limbs according to MAS grade 1 to 1+ .
  • •They will be at levels I and II based on the GMFCS

排除标准

  • •Children with any neurological conditions other than hemiplegic cerebral palsy will be excluded from the study.
  • •Musculoskeletal problems or congenital deformity.
  • •Children with fixed contracture.
  • •Lower limb surgery in the last one year.
  • •Rhizotomy, or injection of botulinum toxin into the lower limb muscles during the previous 6 months.
  • •Receive any medications that affect the arousal and alertness status.
  • •Children having epilepsy.
  • •Visual or auditory defects.
  • •Skin sensitivity.

研究组 & 干预措施

Control group

Active Comparator

This group will include 15 children with hemiplegic cerebral palsy and will receive a split 60 minutes, 30 minutes of traditional physical therapy and 30 minutes of weight-bearing exercise , 3 sessions/ week for 8 weeks.

干预措施: traditional physical therapy and weight-bearing exercise (Other)

Study group

Experimental

This group will include 15 children with hemiplegic cerebral palsy and will receive the same 60 minutes session of the control group in addition to neuromuscular electrical stimulation during the 30 minutes weight-bearing program , 3 sessions/ week for 8 weeks.

干预措施: neuromuscular electrical stimulation , traditional physical therapy and weight-bearing exercise (Other)

结局指标

主要结局

Balance

时间窗: up to 8 Weeks

The HUMAC Balance System (HUMAC2015® Version: 15.000.0103; Computer Sports Medicine, Inc.) will assess pediatric postural balance before and after treatment. This system, featuring a force plate and specialized software, provides precise and reliable measurements of static and dynamic balance, supported by established reliability in pediatric studies.

次要结局

  • The Gross Motor Function Measure GMFM(Up to 8 weeks)

研究者

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

Abdulrahman Ahmad Mohamad Mostafa

Abdulrahman Ahmad Mohamad Mostafa

Cairo University

相似试验