HemiparesisNCT07648511
Effect of Task Oriented Training With Functional Electrical Stimulation on Balance in Children With Hemiparesis
A study testing Selected therapeutic program, Selected Task oriented training program and Selected Functional electrical stimulation in people with Hemiparesis and Children, Only, run by Cairo University at 1 site in Egypt.
Trial summary
To investigate the efficacy of combination of task-oriented training and Functional electrical stimulation of ankle dorsiflexor muscles on: 1. Strength of ankle muscles in children with hemiparesis. 2. Balance in children with hemiparesis. Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Hemiparesis, Children, Only
- What is being tested?
- Selected therapeutic program, Selected Task oriented training program and Selected Functional electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Apr 2026to 5 Jul 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 6 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The age of the selected children will be ranged from 6 to 9 years.
- Able to follow simple instructions.
- Degree of spasticity is ranging from 1to 1+ according to modified Ashworth scale.
- The level of motor function of the children will be levels I-II according to Gross Motor Function Classification System.
Who cannot join
- The children will be excluded if they have one or more of the following criteria:
- Visual, hearing disorders.
- Recent Botox injection or orthopedic surgery in the lower limb in the last 6 months before the start of the study.
- Any fixed deformity of lower limb.
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, 1 recruiting
- Recruiting
Damietta general hospital.
Damietta
Nourhan Reda Abdel Razek Dawood, physical therapist, 01017173755, Eman_pediatrics2016@yahoo.com
About this study
To investigate the efficacy of combination of task-oriented training and Functional electrical stimulation of ankle dorsiflexor muscles on:
- Strength of ankle muscles in children with hemiparesis.
- Balance in children with hemiparesis.
Read the detailed description
Children with hemiparetic cerebral palsy often favor their non-paretic side, leading to asymmetrical walking and balance issues. Muscle weakness significantly restricts motor function, prompting a shift from spasticity management to strength training, which has a positive correlation with gross motor function and gait. Task-oriented training has been shown to enhance balance. Children with hemiparesis tend to prefer mobility equipment due to balance disturbances. Functional electrical stimulation of ankle dorsiflexors combined with task-oriented training is being investigated for its effectiveness in improving balance in these children.
- Conditions
- Hemiparesis, Children, Only
- Being tested
- Selected therapeutic program, Selected Task oriented training program, Selected Functional electrical stimulation
- Medical subject headings
- Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selected therapeutic programOther
The program will run three days a week on non-consecutive days, focusing on various exercises for children. Activities include: 1) knee manipulation for balance; 2) guided body weight shifting; 3) balancing on a board; 4) training for equilibrium and protective reactions; 5) gait training in a closed environment with obstacles; 6) open environment gait training; 7) strengthening exercises for the back, hips, and knees; and 8) passive stretching for tight muscles in both lower and upper limbs.
Selected Task oriented training programOther
- Activities involve standing and reaching for objects at various distances and heights. 2. Sit-to-stand tasks are performed from different chair heights and while carrying objects. 3. Stepping activities occur in various directions and on different block heights and surfaces. 4. Alternating heel and toe raises focus on increasing repetitions. 5. Stairs are ascended and descended with added weight and object carrying. 6. Backward walking starts near a wall, progressing to shuttle runs. 7. Walking on a balance beam involves increased speed and varied surfaces.
Selected Functional electrical stimulationDevice
The study will utilize Everyway Medical Instruments for electrical stimulation, with one electrode on the tibialis anterior muscle and the other on the common peroneal nerve. A tilt sensor will trigger stimulation during the swing phase of the tibia. The stimulation parameters include a pulse frequency of 25-40 hertz, a pulse duration of 250 to 300 milliseconds, and an on-off time ratio of 1:2 for 20 minutes, aimed at inducing ankle dorsiflexion while preventing inversion.
| Study group | Role | What they receive |
|---|---|---|
| conventional exercise program | Active comparator | The control group consist of 18 children will receive conventional exercise program for 60 min. Receives: Other: Selected therapeutic program |
| task-oriented training | Experimental | Study group consist of 18 children will receive task-oriented training while applying the functional electrical stimulation on the affected lower limb for 20 min in addition to conventional exercise program for 40 min. Receives: Other: Selected therapeutic program; Other: Selected Task oriented training program; Device: Selected Functional electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of balance
Pediatric balance scale will be used to assess balance for all children participated in this study. It contains 14-item. Scoring for each item is scored 0 points (lowest function) to 4 points (highest function), with maximum score of 56 points. Calculation of the total score by summation of the score of the 14 items
Measured: at baseline and after 8 weeks
Secondary outcomes (1)
Assessment of muscle strength
Each child will practice two trials per test to ensure familiarity. Peak force values will be recorded using the handheld dynamometer after three trials for both break and method tests for each muscle group. Standardized instructions will be provided, and encouragement will be given for maximal effort. During the break test, force will increase progressively over one second to maximize muscle fiber activation. Children will be shown test conduct prior to starting three trials. For the tibialis anterior muscle test, children will lay on a plinth with legs restrained and push against a device with their foot. Assessing ankle muscle groups, especially plantar flexors and dorsiflexors, is crucial for understanding power generation in walking and gait speed, particularly in stroke patients, while testing positions will be optimized for clinical feasibility.
Measured: at baseline and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start5 Apr 2026
- Primary completion5 Jun 2026
- Study completion5 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiparesisStudies 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Kamal Abdelmoteleb, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648511
- Sponsor's protocol ID
- Nourhan_Msc
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 15 Jun 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 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Task Oriented Training With Functional Electrical Stimulation on Balance in Children With Hemiparesis
- ClinicalTrials.gov ID
- NCT07648511
- Acronym / sponsor ID
- Nourhan_Msc
- Conditions
- Hemiparesis, Children, Only
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Apr 2026 (actual)
- Primary completion
- 5 Jun 2026 (actual)
- Study completion
- 5 Jul 2026 (estimated)
- First posted
- 15 Jun 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.
To investigate the efficacy of combination of task-oriented training and Functional electrical stimulation of ankle dorsiflexor muscles on:
- Strength of ankle muscles in children with hemiparesis.
- Balance in children with hemiparesis.
Detailed description
Children with hemiparetic cerebral palsy often favor their non-paretic side, leading to asymmetrical walking and balance issues. Muscle weakness significantly restricts motor function, prompting a shift from spasticity management to strength training, which has a positive correlation with gross motor function and gait. Task-oriented training has been shown to enhance balance. Children with hemiparesis tend to prefer mobility equipment due to balance disturbances. Functional electrical stimulation of ankle dorsiflexors combined with task-oriented training is being investigated for its effectiveness in improving balance in these children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional exercise program | Active comparator | Other: Selected therapeutic programThe control group consist of 18 children will receive conventional exercise program for 60 min. |
| task-oriented training | Experimental | Other: Selected therapeutic program, Other: Selected Task oriented training program, Device: Selected Functional electrical stimulationStudy group consist of 18 children will receive task-oriented training while applying the functional electrical stimulation on the affected lower limb for 20 min in addition to conventional exercise program for 40 min. |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- The age of the selected children will be ranged from 6 to 9 years.
- Able to follow simple instructions.
- Degree of spasticity is ranging from 1to 1+ according to modified Ashworth scale.
- The level of motor function of the children will be levels I-II according to Gross Motor Function Classification System.
Key exclusion criteria (4 listed)
- Visual, hearing disorders.
- Recent Botox injection or orthopedic surgery in the lower limb in the last 6 months before the start of the study.
- Any fixed deformity of lower 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 |
|---|---|---|
| Selected therapeutic programThe program will run three days a week on non-consecutive days, focusing on various exercises for children. Activities include: 1) knee manipulation for balance; 2) guided body weight shifting; 3) balancing on a board; 4) training for equilibrium and protective reactions; 5) gait training in a closed environment with obstacles; 6) open environment gait training; 7) strengthening exercises for the back, hips, and knees; and 8) passive stretching for tight muscles in both lower and upper limbs. | Other | conventional exercise program, task-oriented training |
| Selected Task oriented training program1. Activities involve standing and reaching for objects at various distances and heights. 2. Sit-to-stand tasks are performed from different chair heights and while carrying objects. 3. Stepping activities occur in various directions and on different block heights and surfaces. 4. Alternating heel and toe raises focus on increasing repetitions. 5. Stairs are ascended and descended with added weight and object carrying. 6. Backward walking starts near a wall, progressing to shuttle runs. 7. Walking on a balance beam involves increased speed and varied surfaces. | Other | task-oriented training |
| Selected Functional electrical stimulationThe study will utilize Everyway Medical Instruments for electrical stimulation, with one electrode on the tibialis anterior muscle and the other on the common peroneal nerve. A tilt sensor will trigger stimulation during the swing phase of the tibia. The stimulation parameters include a pulse frequency of 25-40 hertz, a pulse duration of 250 to 300 milliseconds, and an on-off time ratio of 1:2 for 20 minutes, aimed at inducing ankle dorsiflexion while preventing inversion. | Device | task-oriented training |
Primary outcome
Assessment of balance
Time frame: at baseline and after 8 weeks
Pediatric balance scale will be used to assess balance for all children participated in this study. It contains 14-item. Scoring for each item is scored 0 points (lowest function) to 4 points (highest function), with maximum score of 56 points. Calculation of the total score by summation of the score of the 14 items
1 secondary outcome
Assessment of muscle strength
Time frame: at baseline and after 8 weeks
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 15 Jun 2026.
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Evaluation of the Safety and Performance of the AWAKE Device in Patients With Hemiplegia or Hemiparesis Secondary to Stroke (ACV).
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Quadriceps Muscle Activity and Gait Kinematics in Patients With Post-Stroke Stiff-Knee Gait Compared With Healthy Controls
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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.
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 therapeutic program, Selected Task oriented training program and Selected Functional electrical stimulation in people with Hemiparesis and Children, Only, 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 4 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 15 Jun 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 Nourhan Reda Abdel Razek Dawood, physical therapist (01017173755, Eman_pediatrics2016@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of balance (time frame: at baseline and after 8 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 15 Jun 2026.