MyofeedbackNCT07606222
Effect of Myofeedback and Neuromuscular Electrical Stimulation on Hemiplegic Children After Brain Tumor Resection
A study testing selected physical therapy program, biofeedback and neuromuscular electric stimulation in people with Myofeedback and Hemiplegia, run by Cairo University at 1 site in Egypt.
Trial summary
This study was conducted to compare between the effect of neuromuscular electrical stimulation and myofeedback on upper limb function, muscle activity and brain derived neurotropic factor in blood for children with hemiplegia after brain tumor surgery. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Myofeedback, Hemiplegia, Child, Only
- What is being tested?
- selected physical therapy program, biofeedback and neuromuscular electric stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 6-14 years post brain tumor surgery children.
- Children's hand use experience questionnaire between 25 and 50 on a scale of units.
- Grade 2 muscle power of wrist, elbow and finger extensors.
- Outpatient children.
- Post-operative brain tumour, which is located in one of the two hemispheres.
- After 6 weeks post-surgery.
- The child can follow orders and instructions.
Who cannot join
- Blindness.
- Deaf child.
- Skin diseases.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Elmagd physical therapy centres, Teriaq oncology centre and Elite hospital.
Alexandria
About this study
This study was conducted to compare between the effect of neuromuscular electrical stimulation and myofeedback on upper limb function, muscle activity and brain derived neurotropic factor in blood for children with hemiplegia after brain tumor surgery.
Read the detailed description
Studies indicate that neuromuscular electrical stimulation is more effective than voluntary exercise in enhancing serum Brain-derived neurotrophic factor levels and improving muscle strength and mobility in children with conditions like cerebral palsy and spinal muscular atrophy. Myofeedback, particularly surface electromyography biofeedback, is beneficial for upper extremity function post-stroke, as it helps raise awareness and control of movements. Intensive electromyography biofeedback has shown significant recovery in hemiplegic children compared to traditional therapy. There is potential for a multimodal treatment approach that combines neuromuscular electrical stimulation and biofeedback to mitigate the effects of brain tumors on upper limb function and optimize Brain-derived neurotrophic factor levels.
- Conditions
- Myofeedback, Hemiplegia, Child, Only
- Being tested
- selected physical therapy program, biofeedback, neuromuscular electric stimulation
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
selected physical therapy programOther
The program includes push-up exercises, active strength training for wrist extensors using fine motor toys, stretching for wrist and elbow flexors and pronators, weight-bearing positions from side sitting, quadruped position with active limb elevation, rolling a small ball with the affected limb, and rhythmic muscle approximation for shoulder, elbow, and wrist.
biofeedbackDevice
During sessions, the child sits with an arm resting on a table, with electrodes placed on the wrist extensors and forearm. The treatment involves gradually increasing the intensity of faradic current to induce muscle contraction. Each session lasts 30 minutes to one hour, with treatments up to three times daily, using a frequency of 50-100 Hz and a pulse duration of 0.1-1 ms, for a duration of 2 weeks to 3 months.
neuromuscular electric stimulationDevice
The child will participate in a physical therapy program for one hour, three times a week, over twelve weeks, supplemented by neuromuscular electric stimulation. During sessions, the child sits with an arm resting on a table, with electrodes placed on the wrist extensors and forearm. The treatment involves gradually increasing the intensity of faradic current to induce muscle contraction. Each session lasts 30 minutes to one hour, with treatments up to three times daily, using a frequency of 50-100 Hz and a pulse duration of 0.1-1 ms, for a duration of 2 weeks to 3 months.
| Study group | Role | What they receive |
|---|---|---|
| selected physical therapy program | Active comparator | The control group will undergo a selected physical therapy (PT) program for one hour, three times weekly, over twelve weeks. Receives: Other: selected physical therapy program |
| selected physical therapy program and biofeedback | Experimental | Patient will undergo a selected physical therapy program for one hour, three times a week, for twelve weeks, supplemented by a biofeedback program. Receives: Other: selected physical therapy program; Device: biofeedback |
| selected physical therapy program and neuromuscular electric stimulation | Experimental | The child will participate in a physical therapy program for one hour, three times a week, over twelve weeks, supplemented by neuromuscular electric stimulation. Receives: Other: selected physical therapy program; Device: neuromuscular electric stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of muscle activity
All children will be assessed using surface electromyography for wrist extensor muscles while sitting, with their upper limbs resting on a desk and utilizing three electrodes. The ground electrode (black) is placed proximal to the others, the active electrode (yellow) is on the common extensor origin, and the connector (blue) is positioned at least 3 cm distally. After registering new patient data, the assessment begins via a one-channel surface electromyography setup, recording maximum and mean muscle activity during wrist extension upon pressing the play button.
Measured: at baseline and after 12 weeks
Secondary outcomes (3)
Assessment of upper limb function
Using the short form of the Bruininks-Oseretsky Test, which includes fourteen selected test items, subtests 1, 2, 3, 4, and 7 are administered. The child is positioned sitting at a table. The time taken for each task is noted as part of the proficiency evaluation. Performance is recorded, and raw scores are converted to point scores using a conversion table. The better result from two trials for each item is taken, and the total points from the fourteen short items are recorded in the designated area.
Measured: at baseline and after 12 weeks
assessment of level of neurotrophic factor
Fasting blood samples were taken in potassium-methylene diamine tetra acetic acid tubes, centrifuged for 15 minutes at 3000 rpm, and the plasma was stored at -80°C before being sent to Myriad RBM for a 190-analyte multiplex immunoassay. Additionally, the Brain-derived neurotrophic factor enzyme-linked immunosorbent assay reliably measures whole blood Brain-derived neurotrophic factor with high reproducibility.
Measured: at baseline and after 12 weeks
assessment of dynamic spasticity of wrist and elbow flexors muscles
Dynamic spasticity of wrist and elbow flexors muscles will be analyzed at the study's start and end. Measurements will include resistance 1 (fast velocity movement through full range of motion to identify the point of catch), resistance 2 (passive range of motion), and the difference resistance 2-resistance 1 (dynamic spasticity component). The Modified Ashworth Scale serves as a clinical tool for assessing spasticity, employing quantitative measurements at two speeds: slow (resistance 2) and fast (resistance 1).
Measured: at baseline and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start1 Jul 2024
- Primary completion1 Jun 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyofeedbackStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Mohamed Sabry Lotfi Amer, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07606222
- Sponsor's protocol ID
- Amr-phd
- Status last verified
- May 2026
- First submitted
- 17 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Myofeedback and Neuromuscular Electrical Stimulation on Hemiplegic Children After Brain Tumor Resection
- ClinicalTrials.gov ID
- NCT07606222
- Acronym / sponsor ID
- Amr-phd
- Conditions
- Myofeedback, Hemiplegia, Child, Only
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 26 May 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.
This study was conducted to compare between the effect of neuromuscular electrical stimulation and myofeedback on upper limb function, muscle activity and brain derived neurotropic factor in blood for children with hemiplegia after brain tumor surgery.
Detailed description
Studies indicate that neuromuscular electrical stimulation is more effective than voluntary exercise in enhancing serum Brain-derived neurotrophic factor levels and improving muscle strength and mobility in children with conditions like cerebral palsy and spinal muscular atrophy. Myofeedback, particularly surface electromyography biofeedback, is beneficial for upper extremity function post-stroke, as it helps raise awareness and control of movements. Intensive electromyography biofeedback has shown significant recovery in hemiplegic children compared to traditional therapy. There is potential for a multimodal treatment approach that combines neuromuscular electrical stimulation and biofeedback to mitigate the effects of brain tumors on upper limb function and optimize Brain-derived neurotrophic factor levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| selected physical therapy program | Active comparator | Other: selected physical therapy programThe control group will undergo a selected physical therapy (PT) program for one hour, three times weekly, over twelve weeks. |
| selected physical therapy program and biofeedback | Experimental | Other: selected physical therapy program, Device: biofeedbackPatient will undergo a selected physical therapy program for one hour, three times a week, for twelve weeks, supplemented by a biofeedback program. |
| selected physical therapy program and neuromuscular electric stimulation | Experimental | Other: selected physical therapy program, Device: neuromuscular electric stimulationThe child will participate in a physical therapy program for one hour, three times a week, over twelve weeks, supplemented by neuromuscular electric stimulation. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age 6-14 years post brain tumor surgery children.
- Children's hand use experience questionnaire between 25 and 50 on a scale of units.
- Grade 2 muscle power of wrist, elbow and finger extensors.
- Outpatient children.
- Post-operative brain tumour, which is located in one of the two hemispheres.
Key exclusion criteria (3 listed)
- Blindness.
- Deaf child.
- Skin diseases.
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 |
|---|---|---|
| selected physical therapy programThe program includes push-up exercises, active strength training for wrist extensors using fine motor toys, stretching for wrist and elbow flexors and pronators, weight-bearing positions from side sitting, quadruped position with active limb elevation, rolling a small ball with the affected limb, and rhythmic muscle approximation for shoulder, elbow, and wrist. | Other | selected physical therapy program, selected physical therapy program and biofeedback, selected physical therapy program and neuromuscular electric stimulation |
| biofeedbackDuring sessions, the child sits with an arm resting on a table, with electrodes placed on the wrist extensors and forearm. The treatment involves gradually increasing the intensity of faradic current to induce muscle contraction. Each session lasts 30 minutes to one hour, with treatments up to three times daily, using a frequency of 50-100 Hz and a pulse duration of 0.1-1 ms, for a duration of 2 weeks to 3 months. | Device | selected physical therapy program and biofeedback |
| neuromuscular electric stimulationThe child will participate in a physical therapy program for one hour, three times a week, over twelve weeks, supplemented by neuromuscular electric stimulation. During sessions, the child sits with an arm resting on a table, with electrodes placed on the wrist extensors and forearm. The treatment involves gradually increasing the intensity of faradic current to induce muscle contraction. Each session lasts 30 minutes to one hour, with treatments up to three times daily, using a frequency of 50-100 Hz and a pulse duration of 0.1-1 ms, for a duration of 2 weeks to 3 months. | Device | selected physical therapy program and neuromuscular electric stimulation |
Primary outcome
Assessment of muscle activity
Time frame: at baseline and after 12 weeks
All children will be assessed using surface electromyography for wrist extensor muscles while sitting, with their upper limbs resting on a desk and utilizing three electrodes. The ground electrode (black) is placed proximal to the others, the active electrode (yellow) is on the common extensor origin, and the connector (blue) is positioned at least 3 cm distally. After registering new patient data, the assessment begins via a one-channel surface electromyography setup, recording maximum and mean muscle activity during wrist extension upon pressing the play button.
3 secondary outcomes
Assessment of upper limb function
Time frame: at baseline and after 12 weeks
assessment of level of neurotrophic factor
Time frame: at baseline and after 12 weeks
assessment of dynamic spasticity of wrist and elbow flexors muscles
Time frame: at baseline and after 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing selected physical therapy program, biofeedback and neuromuscular electric stimulation in people with Myofeedback and Hemiplegia, 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 7 inclusion and 3 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: finished, as of the sponsor's last update on 26 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of muscle activity (time frame: at baseline and after 12 weeks). 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 26 May 2026.