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Recruiting NCT07648511

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

No phase Interventional Hemiparesis Children, Only

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Selected therapeutic program, Selected Task oriented training program, Selected Functional electrical stimulation.
Who it may be relevant to
Registry conditions: Hemiparesis, Children, Only. Basic parameters: 6 years — 9 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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.

Interventions

  • Other Selected 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.
  • Other Selected 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. Walk
  • Device Selected 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.

Primary outcome measures

  • Assessment of balance [Time frame: at baseline and after 8 weeks]
Secondary outcome measures (1)
  • Assessment of muscle strength [Time frame: at baseline and after 8 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Damietta general hospital. — Damietta

Identifiers

NCT: NCT07648511 · Nourhan_Msc

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗