HemiplegiaNCT06729190
Effect of Biofeedback and Functional Electrical Stimulation in Children
A study testing biofeedback and Physical therapy program in people with Hemiplegia, run by Cairo University at 1 site in Egypt.
Trial summary
40 children with hemiplegia cerebral palsy from both sex will be recruited from outpatient clinic of abo resh hospital ,their age ranged from 5-10 years Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Hemiplegia
- What is being tested?
- biofeedback and Physical therapy program
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2024to Mar 2025
- 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 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Their age will range from 5 to 10 years.
- Spasticity grade range from 1+ to 2, according to Modified Ashworth Scale (MAS) (Bohannon and Smith, 2011).
- Their UL ability function will be at level II according to Manual Ability Classification System (MACS) (Penta et al., 2001).
- They will be able to follow instructions.
Who cannot join
- Loss of sensation
- The presence of visual or auditory impairments.
- Musculoskeletal problems or fixed deformities in the upper extremities.
- Seizures.
- Surgical interference in upper limbs.
- Botulinum toxin injections in the last 6 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Combined Effect of Biofeedback and Functional Electrical Stimulation on Upper Limb Functions in Children With Hemiplegia
40 children with hemiplegia cerebral palsy from both sex will be recruited from outpatient clinic of abo resh hospital ,their age ranged from 5-10 years
Read the detailed description
40 children with hemiplegia cerebral palsy from both sex will be recruited ,their age ranged from 5-10 years, treatment includes functional electrical nerve stimulation and biofeedback to assess their combined effect on upper limb function
- Conditions
- Hemiplegia
- Being tested
- biofeedback, Physical therapy program
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biofeedbackDevice
biofeedback therapy and FES at anti spastic muscles(shoulders flexors, elbow and wrist extensors) while doing specific exercises (including basic reaching, grasping, carrying, release
Physical therapy programProcedure or surgery
Flexibility exercises for shorted muscles and spastic muscles, Strengthening training focusing on the trunk lower limb and upper limb muscles for weak muscles, Postural control exercise in different positions and different surfaces, General endurance training, Exercises to facilitate hand function, Exercises included, grasping a cube, transferring cube, removing and placing pegs, releasing cube and placing cubes. Strengthening exercises of the intrinsic muscles of the hand
| Study group | Role | What they receive |
|---|---|---|
| Group A | Placebo comparator | Physical therapy program The exercise session for one hour for each child , conducted 3times/ week for 3 successive months.
1. Flexibility exercises for shorted muscles and spastic muscles.
2. Strengthening training focusing on the trunk lower limb and upper limb muscles for weak muscles.
3. Postural control exercise in different positions and different surfaces
4. General endurance training
5. Exercises to facilitate hand function
6. Exercises included, grasping a cube, transferring cube, removing and placing pegs, releasing cube and placing cubes. Strengthening exercises of the intrinsic muscles of the hand Receives: Procedure: Physical therapy program |
| Group B | Experimental | The exercise session for one hour for each child same as group A, conducted 3times/ week for 3 successive months plus the combined biofeedback therapy and FES at anti spastic muscles (shoulders flexors, elbow and wrist extensors Receives: Device: biofeedback; Procedure: Physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
hand function in children with CP
hand function in children with CP will be assessed by The Quality of Upper Extremity Skills Test
Measured: pre intervention and re assessed after 3 months of treatment
Secondary outcomes (2)
Range of motion
Range of motion will be assessed using Electronic goniometer
Measured: pre intervention and re assessed after 3 months of treatment
muscle grip strength
muscle grip strength will be assessed using Hand held dynamometer
Measured: pre intervention and re assessed after 3 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study startDec 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies 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
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Eldin Taha Ramadan, Cairo University
- Investigators
- Khaled A Mamdouh, PHD, Study director, professor of physical therapyEman I Alhadedy, PHD, Study director, Professor of physical therapyAmira I Fathi, Study director, Lecturer of physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729190
- Sponsor's protocol ID
- 012/005003
- Status last verified
- Dec 2024
- First submitted
- 8 Dec 2024
- Last updated
- 20 Dec 2024
- 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 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effect of Biofeedback and Functional Electrical Stimulation on Upper Limb Functions in Children With Hemiplegia
- ClinicalTrials.gov ID
- NCT06729190
- Acronym / sponsor ID
- 012/005003
- Conditions
- Hemiplegia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 11 Dec 2024 (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.
40 children with hemiplegia cerebral palsy from both sex will be recruited from outpatient clinic of abo resh hospital ,their age ranged from 5-10 years
Detailed description
40 children with hemiplegia cerebral palsy from both sex will be recruited ,their age ranged from 5-10 years, treatment includes functional electrical nerve stimulation and biofeedback to assess their combined effect on upper limb function
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Placebo comparator | Procedure: Physical therapy programPhysical therapy program The exercise session for one hour for each child , conducted 3times/ week for 3 successive months. 1. Flexibility exercises for shorted muscles and spastic muscles. 2. Strengthening training focusing on the trunk lower limb and upper limb muscles for weak muscles. 3. Postural control exercise in different positions and different surfaces 4. General endurance training 5. Exercises to facilitate hand function 6. Exercises included, grasping a cube, transferring cube, removing and placing pegs, releasing cube and placing cubes. Strengthening exercises of the intrinsic muscles of the hand |
| Group B | Experimental | Device: biofeedback, Procedure: Physical therapy programThe exercise session for one hour for each child same as group A, conducted 3times/ week for 3 successive months plus the combined biofeedback therapy and FES at anti spastic muscles (shoulders flexors, elbow and wrist extensors |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Their age will range from 5 to 10 years.
- Spasticity grade range from 1+ to 2, according to Modified Ashworth Scale (MAS) (Bohannon and Smith, 2011).
- Their UL ability function will be at level II according to Manual Ability Classification System (MACS) (Penta et al., 2001).
- They will be able to follow instructions.
Key exclusion criteria (6 listed)
- Loss of sensation
- The presence of visual or auditory impairments.
- Musculoskeletal problems or fixed deformities in the upper extremities.
- Seizures.
- Surgical interference in upper limbs.
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 |
|---|---|---|
| biofeedbackbiofeedback therapy and FES at anti spastic muscles(shoulders flexors, elbow and wrist extensors) while doing specific exercises (including basic reaching, grasping, carrying, release | Device | Group B |
| Physical therapy programFlexibility exercises for shorted muscles and spastic muscles, Strengthening training focusing on the trunk lower limb and upper limb muscles for weak muscles, Postural control exercise in different positions and different surfaces, General endurance training, Exercises to facilitate hand function, Exercises included, grasping a cube, transferring cube, removing and placing pegs, releasing cube and placing cubes. Strengthening exercises of the intrinsic muscles of the hand | Procedure or surgery | Group A, Group B |
Primary outcome
hand function in children with CP
Time frame: pre intervention and re assessed after 3 months of treatment
hand function in children with CP will be assessed by The Quality of Upper Extremity Skills Test
2 secondary outcomes
Range of motion
Time frame: pre intervention and re assessed after 3 months of treatment
muscle grip strength
Time frame: pre intervention and re assessed after 3 months of treatment
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 20 Dec 2024.
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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.
Khaled A Mamdouh, PHD study director
professor of physical therapy
Eman I Alhadedy, PHD study director
Professor of physical therapy
Amira I Fathi study director
Lecturer of physical therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biofeedback and Physical therapy program in people with 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 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: looking for participants now, as of the sponsor's last update on 20 Dec 2024. 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. Some participants in this study may receive a placebo. 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 Alaa T Ramadan, M.SC (01019320008, dr.alaataha@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hand function in children with CP (time frame: pre intervention and re assessed after 3 months of treatment). 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 20 Dec 2024.