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NCT Number: NCT06729190

Effect of Biofeedback and Functional Electrical Stimulation in Children

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

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Key information

Conditions

Hemiplegia Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Giza, 12613, Egypt

Location status: Recruiting

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

biofeedback

Device

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

Physical therapy program

Procedure

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 outcomes

  1. hand function in children with CP

    Time frame: pre intervention and re assessed after 3 months of treatment

    hand function in children with CP will be assessed by The Quality of Upper Extremity Skills Test

Secondary outcomes

  1. Range of motion

    Time frame: pre intervention and re assessed after 3 months of treatment

    Range of motion will be assessed using Electronic goniometer

  2. muscle grip strength

    Time frame: pre intervention and re assessed after 3 months of treatment

    muscle grip strength will be assessed using Hand held dynamometer

Study contacts

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

Alaa T Ramadan, M.SC

CONTACT

[email protected]

01019320008

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 11, 2024
Registry last updated
Dec 20, 2024

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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