Effect of Biofeedback and Functional Electrical Stimulation in Children

NCT06729190 | Recruiting

• 1 other identifier: 012/005003
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hemiplegia

Outcome Measures

Primary Outcomes (1)

• hand function in children with CP

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

  pre intervention and re assessed after 3 months of treatment

Secondary Outcomes (2)

• Range of motion

  pre intervention and re assessed after 3 months of treatment

• muscle grip strength

  pre intervention and re assessed after 3 months of treatment

Study Arms (2)

Group A

PLACEBO COMPARATOR

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

Procedure: Physical therapy program

Group B

EXPERIMENTAL

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

Device: biofeedback; Procedure: Physical therapy program

Interventions

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

Group B

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

Group A; Group B

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, 12613, Egypt

RECRUITING

MeSH Terms

Conditions

Hemiplegia

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Khaled A Mamdouh, PHD

  professor of physical therapy

  STUDY DIRECTOR

• Eman I Alhadedy, PHD

  Professor of physical therapy

  STUDY DIRECTOR

• Amira I Fathi

  Lecturer of physical therapy

  STUDY DIRECTOR

Central Study Contacts

Alaa T Ramadan, M.SC

CONTACT

01019320008; dr.alaataha@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant lecturer

Study Record Dates

• First Submitted: December 8, 2024
• First Posted: December 11, 2024
• Study Start: December 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: December 20, 2024

Record last verified: 2024-12

Locations

EG (1)