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RecruitingNCT07648511Updated Jun 15, 2026

Effect of Task Oriented Training With Functional Electrical Stimulation on Balance in Children With Hemiparesis

An interventional study of Selected therapeutic program and Selected Task oriented training program in Hemiparesis and Children, Only, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 6 Years to 9 Years. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2026; still recruiting 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
6 Years to 9 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Hemiparesis
  • Children, Only

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03

In context

Paresis

468 studies on the registry are indexed under Paresis; 117 are open to participants now.

This study's planned enrollment of 36 is close to the median of 37 across 420 interventional studies indexed under Paresis.

Browse Paresis studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 9 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. The age of the selected children will be ranged from 6 to 9 years.
  2. Able to follow simple instructions.
  3. Degree of spasticity is ranging from 1to 1+ according to modified Ashworth scale.
  4. The level of motor function of the children will be levels I-II according to Gross Motor Function Classification System.

Exclusion criteria

Exclusion Criteria:

The children will be excluded if they have one or more of the following criteria:

  1. Visual, hearing disorders.
  2. Recent Botox injection or orthopedic surgery in the lower limb in the last 6 months before the start of the study.
  3. Any fixed deformity of lower limb.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
36 participants (estimated)

Study arms

  • Active comparator
    conventional exercise program

    The control group consist of 18 children will receive conventional exercise program for 60 min.

    Other: Selected therapeutic program

  • Experimental
    task-oriented training

    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.

    Other: Selected therapeutic program · Other: Selected Task oriented training program · Device: Selected Functional electrical stimulation

Interventions

  • OtherSelected therapeutic program

    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.

  • OtherSelected Task oriented training program

    1\. 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.

  • DeviceSelected Functional electrical stimulation

    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.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 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.

    Time frame: at baseline and after 8 weeks

07

Study locations

1 of 1 sites recruiting
  • Damietta general hospital.
    Damietta, Egypt
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2026 to primary completion in Jun 2026, 2 months.

Of 221 non-industry interventional studies with no phase under Paresis, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 55. This study's 2 months is below that.

Counting every sponsor, half of 239 studies reached it within 32 months; a quarter within 13 and three quarters within 55.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 10, 2026
First posted
Jun 15, 2026
StartActual
Apr 5, 2026
Primary completionActual
Jun 5, 2026
CompletionEst.
Jul 5, 2026
Last update
Jun 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07648511
Lead sponsor
Cairo University
Responsible party
Eman Kamal Abdelmoteleb (Principal Investigator, Cairo University) — Principal investigator
First posted
Jun 15, 2026
Start date
Apr 5, 2026
Primary completion
Jun 5, 2026
Completion
Jul 5, 2026 (estimated)
Last update
Jun 15, 2026

Study contacts

Nourhan Reda Abdel Razek Dawood, physical therapist
Contact
Eman_pediatrics2016@yahoo.com
01017173755

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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