ELECTROMYOGRAPHY BIOFEEDBACK TRAINING VERSUS MIRROR THERAPY ON MUSCLE ACTIVITY, RANGE OF MOTION AND FUNCTION OF UPPER LIMB IN CHILDREN WITH HEMIPLEGIA
Study Overview
Status
Conditions
Detailed Description
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 previous publication (Chang et al., 2020; Kara et al., 2020), 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).
Randomization Forty hemiplegic children will be randomly assigned into two equal groups; group A and group B. The way of randomization will be using sealed envelopes; each envelope contains a sheet of paper that will show where the child will be assigned; either into group A or group B. The process of randomization will be performed by an independent person who will be blinded to the purpose or protocol of the study.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Andrew G Mourice
- Phone Number: 01278280393
- Email: drandrewgameel1@gmail.com
Study Locations
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Giza Governorate
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Giza, Giza Governorate, Egypt, 12662
- Faculty of Physical Therapy, Cairo University
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Contact:
- Andrew G Mourice
- Phone Number: 01278280393
- Email: drandrewgameel1@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Their age will be ranged from 8 to 12 years.
- They will have spasticity grade 1+ and 2 on the Modified Ashworth Scale
- The children will be at level I and II on the Gross Motor Function Classification System (GMFCS)
- They will be able to follow the instructions.
Exclusion Criteria:
- 1) Visual or hearing defects. 2) Other neurological conditions rather than CP. 3) Surgical intervention of upper limb. 4) Botulinum toxin injection into the upper limb in the last 6 months prior to the study.
5) Fractures of the upper limb. 6) Convulsions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Group A
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
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This intervention has been assigned to 'Group A.'.
The Neurotrac Simplex device has been developed to enhance the understanding of muscle activity and to improve muscle conditioning.
It stands upright on a flat surface, enabling the user to carry out specific exercises and at the same time view the biofeedback by way of bright LED lights on the front of the unit; the LCD screen will automatically display the average muscle readings for the session.
Then using training programs in the NeuroTrac software for facilitation of the desired muscle.
This software will be used in training the program for group A.
This intervention has been assigned to both groups. A designed physical therapy program for 30 minutes three times per week for three successive months
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Experimental: Group B
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.
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This intervention has been assigned to both groups. A designed physical therapy program for 30 minutes three times per week for three successive months
This intervention has been assigned to 'Group B.'A mirror (20 cm × 70 cm) on a movable stand will be used to provide a mirror therapy training program for group B. It stands on mobile wheels surrounded by a frame made of wood, with the main reflective surface likely being a standard glass mirror. The affected limb will be situated in a safe and preferably comfortable position behind the mirror. The non-affected limb will be positioned in a similar position as the affected limb, which would result in facilitating the intensity of the mirror illusion. The therapist will repeatedly remind the child to focus on the movement of the unaffected limb in front of the mirror, which helped to increase the mirror illusion. Under the supervision of the physiotherapist, children observed the reflection of their unaffected limb while performing the following movement: flexion of the shoulder, elbow extension, and wrist extension. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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muscle activity of deltoid, elbow extensor, and wrist extensor muscles
Time Frame: The treatment period will be 3 times per week for 3 successive months
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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
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The treatment period will be 3 times per week for 3 successive months
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ROM of shoulder, elbow, and wrist joints
Time Frame: The treatment period will be 3 times per week for 3 successive months
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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
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The treatment period will be 3 times per week for 3 successive months
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quality of upper limb movement
Time Frame: The treatment period will be 3 times per week for 3 successive months
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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
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The treatment period will be 3 times per week for 3 successive months
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Hebatallah M Kamal, Cairo University, Egypt
- Study Director: Hala R Mahmoud, Cairo University, Egypt
- Study Director: Walaa A Abd El-Nabie, Cairo University, Egypt
- Principal Investigator: Andrew G Mourice, Cairo University, Egypt
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hemiplegic Cerebral Palsy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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