Effect of Biofeedback and Functional Electrical Stimulation in Children

Cairo University (CU)

Status: Enrolling

Conditions: Hemiplegia

Treatments: Device: biofeedback; Procedure: Physical therapy program

Study type: Interventional

Funder types: Other

Identifiers

NCT06729190

012/005003

Details and patient eligibility

About

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

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 5 to 10 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups, including a placebo group

Group A

Placebo Comparator group

Description:

Physical therapy program The exercise session for one hour for each child , conducted 3times/ week for 3 successive months. 1. Flexibility exercises for shorted muscles and spastic muscles. 2. Strengthening training focusing on the trunk lower limb and upper limb muscles for weak muscles. 3. Postural control exercise in different positions and different surfaces 4. General endurance training 5. Exercises to facilitate hand function 6. 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

Treatment:

Procedure: Physical therapy program

Group B

Experimental group

Description:

The exercise session for one hour for each child same as group A, conducted 3times/ week for 3 successive months plus the combined biofeedback therapy and FES at anti spastic muscles (shoulders flexors, elbow and wrist extensors

Treatment:

Procedure: Physical therapy program

Device: biofeedback