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Recruiting NCT06729190

Effect of Biofeedback and Functional Electrical Stimulation in Children

No phase Interventional Hemiplegia

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: biofeedback, Physical therapy program.
Who it may be relevant to
Registry conditions: Hemiplegia. Basic parameters: 5 years — 10 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 →
Official title

Combined Effect of Biofeedback and Functional Electrical Stimulation on Upper Limb Functions in Children With Hemiplegia

Overview

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

Interventions

  • Device biofeedback
    biofeedback therapy and FES at anti spastic muscles(shoulders flexors, elbow and wrist extensors) while doing specific exercises (including basic reaching, grasping, carrying, release
  • Procedure Physical therapy program
    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

Primary outcome measures

  • hand function in children with CP [Time frame: pre intervention and re assessed after 3 months of treatment]
Secondary outcome measures (2)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

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
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Cairo University — Giza

Identifiers

NCT: NCT06729190 · 012/005003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗