Electromyography Biofeedback Training Versus Mirror Therapy on Muscle Activity, Range of Motion and Function of Upper Limb in Children With Hemiplegia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- muscle activity of deltoid, elbow extensor, and wrist extensor muscles
研究概览
简要总结
One of the main motor control issues in hemiplegic CP is spasticity, which affects the flexor muscles of the upper limb. This spasticity causes the limb to adopt a flexed posture, limiting the range of motion and contributing to a decreased ability to perform tasks that require precise movement and controlled muscle activation. Several studies have demonstrated that EMG biofeedback can significantly improve upper limb function in children with hemiplegic CP. Also, mirror therapy has gained recognition as an innovative and effective rehabilitation method for children with hemiplegic CP
详细描述
Ethics statement:
The current study was approved by the local Ethical Committee at the Faculty of Physical Therapy Cairo University (No: P.T.REC/012/005590).
Study Design:
Comparative randomized study.
Sample size estimation Sample size calculation was done using the comparison of QUEST scale as a marker for upper limb functional performance between children with hemiplegic cerebral palsy treated with electromyography biofeedback training and those treated with mirror therapy. As reported in a previous publication, the mean ± SD of length of QUEST scale in Smart Glove group was 328 ± 52, while in conventional group it was 265.4 ± 45.5. Accordingly, we calculated that the minimum proper sample size was 18 participants in each group to be able to reject the null hypothesis with 80% power at α = 0.05 level using Student's t test for independent samples. Sample size calculation was done using PS Power and Sample Size Calculations Software, version 3.1.2 for MS Windows (William D. Dupont and Walton D., Vanderbilt University, Nashville, Tennessee, USA).
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ranging from 8 to 12 years
- •Spasticity grade 1+ and 2 on the Modified Ashworth Scale
- •Gross Motor Function Classification System (GMFCS) level I or II
- •Ability to follow verbal instructions
排除标准
- •Visual or hearing defects
- •Neurological conditions other than cerebral palsy
- •Previous surgical intervention of the upper limb
- •Botulinum toxin injection into the upper limb within the last 6 months prior to the study
- •Fractures of the upper limb
- •Uncontrolled convulsions
研究组 & 干预措施
EMG Biofeedback Training
Children in group A will receive 30 minutes of EMG biofeedback training. The EMG biofeedback device will be placed on the muscles of the upper extremities. First, surface electrodes will be applied at the deltoid muscle for 10 minutes; then electrodes will be applied at the triceps for 10 minutes, and then electrodes will be applied at the wrist extensors for 10 minutes to pick up the activity of the muscles and convert it to visual and auditory impulses produced from the device. In addition to the designed physical therapy program for 30 minutes
干预措施: Neurotrac Simplex electromyography biofeedback device (Device)
EMG Biofeedback Training
Children in group A will receive 30 minutes of EMG biofeedback training. The EMG biofeedback device will be placed on the muscles of the upper extremities. First, surface electrodes will be applied at the deltoid muscle for 10 minutes; then electrodes will be applied at the triceps for 10 minutes, and then electrodes will be applied at the wrist extensors for 10 minutes to pick up the activity of the muscles and convert it to visual and auditory impulses produced from the device. In addition to the designed physical therapy program for 30 minutes
干预措施: a designed physical therapy program (Other)
Mirror Therapy Training
Children in group B will receive 30 minutes of mirror therapy training. Children will be seated on a chair, with the mirror positioned between the upper limbs perpendicular to the child's midline, and the reflecting side of the mirror will be adjusted to face the non-affected arm. Isolated movements of shoulder, elbow, and wrist joints by the unaffected limb will be performed in all degrees of freedom. In each direction up to 30 repetitions per session. In addition to the same designed physical therapy program for 30 minutes as group A.
干预措施: Mirror (Other)
Mirror Therapy Training
Children in group B will receive 30 minutes of mirror therapy training. Children will be seated on a chair, with the mirror positioned between the upper limbs perpendicular to the child's midline, and the reflecting side of the mirror will be adjusted to face the non-affected arm. Isolated movements of shoulder, elbow, and wrist joints by the unaffected limb will be performed in all degrees of freedom. In each direction up to 30 repetitions per session. In addition to the same designed physical therapy program for 30 minutes as group A.
干预措施: a designed physical therapy program (Other)
结局指标
主要结局
muscle activity of deltoid, elbow extensor, and wrist extensor muscles
时间窗: The treatment period will be 3 times per week for 3 successive months
The Neurotrac Simplex EMG biofeedback device (model ESS102, manufactured by Verity Medical Ltd., UK) is a single-channel EMG device that has been designed to be used with a variety of applications. It acts as a diagnostic tool to measure the muscle activity, which is measured in microvolts (μV). The Neurotrac Simplex is an accurate and sensitive device that measures muscle activity down to as low as 0.2 μV and up to 2000 μV. The diverse range enables the device to measure very weak muscle activity
ROM of shoulder, elbow, and wrist joints
时间窗: The treatment period will be 3 times per week for 3 successive months
A goniometer is an instrument that either measures an angle or allows an object to be rotated to a precise angular position. The baseline digital goniometer is used to measure a patient's ROM and incorporates integral absolute vertical and horizontal levels in one arm for ease of use. The device weighs 0.45 kg. The device displays 0 to 180 degrees on an LCD screen for viewing readings and has the ability to freeze angle measurements for reference. The goniometer has a durable powder-coated steel exterior with inch/cm marks screened onto its arms and is powered by one 9V battery (included). (L is length, the horizontal distance from left to right; W is width, the horizontal distance from front to back; H is height, the vertical distance from the lowest to highest point.) These ROM measurements can be taken at any joint, and they typically involve some knowledge about the anatomy of the body, particularly bony landmarks
quality of upper limb movement
时间窗: The treatment period will be 3 times per week for 3 successive months
The Quality of Upper Extremity Skills Test is a descriptive, impairment-based, and evaluative measure designed to evaluate movement patterns and hand function in CP children separately for each arm. It has been validated for children who exhibit neuromotor dysfunction with spasticity. Quality of movement is assessed in four domains: dissociated movements (19 items), grasp (6 items), weight bearing (5 items), and protective extension (3 items), including 33 items. The total testing time, including administration and scoring, is approximately 45 minutes
次要结局
未报告次要终点
研究者
Andrew Gameel Mourice
Principal Investigator
Cairo University