Hemiplegic Cerebral PalsyNCT07818616
Electromyography Biofeedback Training Versus Mirror Therapy on Muscle Activity, Range of Motion and Function of Upper Limb in Children With Hemiplegia
A study testing Neurotrac Simplex electromyography biofeedback device, Mirror and a designed physical therapy program in people with Hemiplegic Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Hemiplegic Cerebral Palsy
- What is being tested?
- Neurotrac Simplex electromyography biofeedback device, Mirror and a designed physical therapy program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Physical Therapy, Cairo University
Giza, Giza Governorate, 12662
Andrew G Mourice, 01278280393, drandrewgameel1@gmail.com
About this study
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
Read the 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 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).
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.
- Conditions
- Hemiplegic Cerebral Palsy
- Being tested
- Neurotrac Simplex electromyography biofeedback device, Mirror, a designed physical therapy program
- Keywords
- Cerebral palsy, Hemiplegia, Mirror therapy, EMG biofeedback
- Medical subject headings
- Cerebral Palsy, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurotrac Simplex electromyography biofeedback deviceDevice
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.
MirrorOther
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.
a designed physical therapy programOther
This intervention has been assigned to both groups. A designed physical therapy program for 30 minutes three times per week for three successive months
- Active resisted exercises:
- Shoulder flexion and abduction. B. Elbow extension. C. Wrist extension.
- Hand weight-bearing exercises:
- Quadriped position B. Side-sitting position C. Hand support standing
- Reaching exercise with shoulder flexion, elbow and wrist extended.
- Throwing the ball overhead by the affected hand and by both hands.
- Protective extensor thrust from sitting on the roll and from the standing position.
- Wheelbarrow walking (walking on hands).
| Study group | Role | What they receive |
|---|---|---|
| EMG Biofeedback Training | Experimental | 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 Receives: Device: Neurotrac Simplex electromyography biofeedback device; Other: a designed physical therapy program |
| Mirror Therapy Training | Experimental | 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. Receives: Other: Mirror; Other: a designed physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle activity of deltoid, elbow extensor, and wrist extensor muscles
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
Measured: The treatment period will be 3 times per week for 3 successive months
ROM of shoulder, elbow, and wrist joints
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
Measured: The treatment period will be 3 times per week for 3 successive months
quality of upper limb movement
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
Measured: The treatment period will be 3 times per week for 3 successive months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start10 Sep 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention, a comparative randomized study. Children in both groups will receive a designed physical therapy program. In addition, children in Group A will receive an EMG biofeedback training program, while children in Group B will receive a mirror therapy training program. The treatment session for both groups will be one hour, three times per week for three successive months
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Gameel Mourice, Cairo University
- Investigators
- Hebatallah M Kamal, Study chair, Cairo University, EgyptHala R Mahmoud, Study director, Cairo University, EgyptWalaa A Abd El-Nabie, Study director, Cairo University, EgyptAndrew G Mourice, Principal investigator, Cairo University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818616
- Sponsor's protocol ID
- Hemiplegic Cerebral Palsy
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromyography Biofeedback Training Versus Mirror Therapy on Muscle Activity, Range of Motion and Function of Upper Limb in Children With Hemiplegia
- ClinicalTrials.gov ID
- NCT07818616
- Acronym / sponsor ID
- Hemiplegic Cerebral Palsy
- Conditions
- Hemiplegic Cerebral Palsy
- Keywords
- Cerebral palsy, Hemiplegia, Mirror therapy, EMG biofeedback
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention, a comparative randomized study. Children in both groups will receive a designed physical therapy program. In addition, children in Group A will receive an EMG biofeedback training program, while children in Group B will receive a mirror therapy training program. The treatment session for both groups will be one hour, three times per week for three successive months
| Arm | Type | Receives |
|---|---|---|
| EMG Biofeedback Training | Experimental | Device: Neurotrac Simplex electromyography biofeedback device, Other: a designed physical therapy programChildren 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 |
| Mirror Therapy Training | Experimental | Other: Mirror, Other: a designed physical therapy programChildren 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. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurotrac Simplex electromyography biofeedback deviceThis 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. | Device | EMG Biofeedback Training |
| MirrorThis 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. | Other | Mirror Therapy Training |
| a designed physical therapy programThis intervention has been assigned to both groups. A designed physical therapy program for 30 minutes three times per week for three successive months 1. Active resisted exercises: A. Shoulder flexion and abduction. B. Elbow extension. C. Wrist extension. 2. Hand weight-bearing exercises: A. Quadriped position B. Side-sitting position C. Hand support standing 3. Reaching exercise with shoulder flexion, elbow and wrist extended. 4. Throwing the ball overhead by the affected hand and by both hands. 5. Protective extensor thrust from sitting on the roll and from the standing position. 6. Wheelbarrow walking (walking on hands). | Other | EMG Biofeedback Training, Mirror Therapy Training |
Primary outcome
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
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
Time frame: 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
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hebatallah M Kamal study chair
Cairo University, Egypt
Hala R Mahmoud study director
Cairo University, Egypt
Walaa A Abd El-Nabie study director
Cairo University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurotrac Simplex electromyography biofeedback device, Mirror and a designed physical therapy program in people with Hemiplegic Cerebral Palsy, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew G Mourice (01278280393, drandrewgameel1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.