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NCT Number: NCT07648511

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

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.

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Key information

Age range

6 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damietta general hospital.

Damietta, Egypt

Location status: Recruiting

Location contact

Nourhan Reda Abdel Razek Dawood, physical therapist

CONTACT

[email protected]

01017173755

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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.

Treatment and study plan

Selected therapeutic program

Other

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 program

Other
  • 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 stimulation

Device

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Assessment of muscle strength

    Time frame: at baseline and after 8 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nourhan Reda Abdel Razek Dawood, physical therapist

CONTACT

[email protected]

01017173755

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 15, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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