Weight Bearing Exercises With NMES on Balance and Functional Abilities In Children With Hemiplegia

NCT07069946 | Not Yet Recruiting

• 1 other identifier: No:P.T.REC/012/005783
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will be conducted to investigate the combining effect of weight-bearing exercises program with neuromuscular electrical stimulation on balance and functional abilities in children with hemiplegic cerebral palsy.

Conditions

Hemiplegic Cerebral Palsy

Keywords

weight-bearing exercises program; neuromuscular electrical stimulation; balance; functional abilities; hemiplegic cerebral palsy

Outcome Measures

Primary Outcomes (1)

• Balance

  The HUMAC Balance System (HUMAC2015® Version: 15.000.0103; Computer Sports Medicine, Inc.) will assess pediatric postural balance before and after treatment. This system, featuring a force plate and specialized software, provides precise and reliable measurements of static and dynamic balance, supported by established reliability in pediatric studies.

  up to 8 Weeks

Secondary Outcomes (1)

• The Gross Motor Function Measure GMFM

  Up to 8 weeks

Study Arms (2)

Control group

ACTIVE COMPARATOR

This group will include 15 children with hemiplegic cerebral palsy and will receive a split 60 minutes, 30 minutes of traditional physical therapy and 30 minutes of weight-bearing exercise , 3 sessions/ week for 8 weeks.

Other: traditional physical therapy and weight-bearing exercise

Study group

EXPERIMENTAL

This group will include 15 children with hemiplegic cerebral palsy and will receive the same 60 minutes session of the control group in addition to neuromuscular electrical stimulation during the 30 minutes weight-bearing program , 3 sessions/ week for 8 weeks.

Other: neuromuscular electrical stimulation , traditional physical therapy and weight-bearing exercise

Interventions

traditional physical therapy and weight-bearing exercise OTHER

They will receive 60 minute session, 3 times/ week for 8 weeks as following: * 30 minutes of traditional physical therapy program : Includes: Strengthening, Stretching, Balance, Postural Control, Functional Mobility and Gait Training. * 30 minutes of seven different weight-bearing exercises program of exercises with three of those being repeated on the left and right sides to make a total of ten exercises, each held for 3 minutes, the exercises include: hamstring stretch, calf stretch, half kneeling balance, static squat, bridge, four point kneeling and four point kneeling with leg extension the exercises include: : Hamstring stretch,Calf stretch , Half kneeling balance , Static Squat, Bridge, Four point kneeling with leg extension, and Four point kneeling.

Control group

neuromuscular electrical stimulation , traditional physical therapy and weight-bearing exercise OTHER

They will receive 60 minute session, 3 times/ week for 8 weeks as following: * 30 minutes of the same traditional physical therapy as the control group. * 30 minutes of the same weight-bearing exercises program as the control group adding to it the neuromuscular electrical stimulation on: Tibialis anterior, Quadriceps, Paraspinal muscles. * NMES Parameters : * Device: Everyway-EV-906. * Frequency: 30-35 Hz (to optimize muscle endurance and motor unit recruitment). * Pulse Width: 250-300 µs. * Intensity: Adjusted to elicit visible muscle contraction without discomfort (submaximal, (25-30 mA). * Electrode Placement: * Lower Limb: Tibialis anterior (for dorsiflexion) and quadriceps (for knee stability) during weight-bearing (El-Shamy and El Kafy, 2021). * Trunk: Paraspinal muscles (for postural control) during static squats and bridging

Study group

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children diagnosed with hemiplegic cerebral palsy.
• Their age will range from 6-10 years.
• Both sexes will be included.
• All participants will be able to follow simple commands.
• They will be graded as mild spasticity of the lower limbs according to MAS grade 1 to 1+ .
• They will be at levels I and II based on the GMFCS

You may not qualify if:

• Children with any neurological conditions other than hemiplegic cerebral palsy will be excluded from the study.
• Musculoskeletal problems or congenital deformity.
• Children with fixed contracture.
• Lower limb surgery in the last one year.
• Rhizotomy, or injection of botulinum toxin into the lower limb muscles during the previous 6 months.
• Receive any medications that affect the arousal and alertness status.
• Children having epilepsy.
• Visual or auditory defects.
• Skin sensitivity.

Sponsors & Collaborators

• Cairo University: lead

Study Officials

• Abdulrahman Mostafa, MSc.

  Master degree

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdulrahman Mostafa, Master

CONTACT

0 11 01012521; ar.ahmad93pt@gmail.com

Abdulrahman Mostafa

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: sealed envelopes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Abdulrahman Ahmad Mohamad Mostafa

Model Details: weight-bearing exercise and neuromuscular electrical stimulation

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 17, 2025
• Study Start: July 15, 2025
• Primary Completion: November 15, 2025
• Study Completion: December 15, 2025
• Last Updated: July 17, 2025

Record last verified: 2025-07