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NCT Number: NCT07069946

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

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.

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Key information

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Hemiplegic cerebral palsy (HCP) is characterized by unilateral motor impairment, with the upper extremities typically exhibiting greater functional limitations compared to the lower limbs. This subtype constitutes approximately 20-30% of cerebral palsy cases and arises from unilateral injury to the developing brain, resulting in asymmetrical muscle tone abnormalities, joint deformities, and restricted range of motion. Individuals with HCP often display irregular, uncoordinated movements on the affected side, significantly impacting motor performance. Children with spastic hemiplegia experience decreased balance ability and abnormal gait because of decreased weight-bearing in the paretic leg. Diminished motor ability in the paretic leg causes weakening of the quadriceps, ankle plantar flexors, and ankle dorsiflexors.

The rehabilitation of balance and walking ability is crucial for children diagnosed with cerebral palsy. Weight-bearing exercises are defined as physical activities in which the feet and legs support the body's weight while moving against gravity. These exercises are essential for stimulating bone growth, improving bone density, and enhancing musculoskeletal health. Examples of weight-bearing exercises include walking, running, jumping, dancing, climbing stairs, playing sports such as soccer or basketball, and engaging in recreational activities like hiking or skating. Regular participation in weight-bearing exercises is particularly important for children and adolescents, as it helps maximize peak bone mass during growth and reduces the risk of osteoporosis later in life.

Exercise programs for cerebral palsy exhibit significant variation in terms of their types, such as gait training, body-weight-supported treadmill training, balance training, or multi-component approaches, and the efficacy of different exercises has not been established in improving the functional abilities of children with cerebral palsy. Studies suggest that integrating neuromuscular electrical stimulation (NMES) with conventional rehabilitation approaches enhances therapeutic outcomes compared to using NMES in isolation .

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

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

Primary outcomes

  1. Balance

    Time frame: up to 8 Weeks

    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.

Secondary outcomes

  1. The Gross Motor Function Measure GMFM

    Time frame: Up to 8 weeks

    The GMFM Will be used for functional abilities evaluation for all children participating in the study before and after treatment procedures. Including the 88-item (GMFM-88) and 66-item (GMFM-66) versions, assesses gross motor function changes in children with cerebral palsy. Both demonstrate high validity and reliability . An adapted GMFM-88 version shows excellent test-retest and inter observer reliability

Study contacts

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

Abdulrahman Mostafa

CONTACT

Abdulrahman Mostafa, Master

CONTACT

[email protected]

0 11 01012521

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Weight Bearing Exercises With Neuromuscular Electrical Stimulation on Balance and Functional Abilities In Children With Hemiplegia

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 17, 2025
Registry last updated
Jul 17, 2025

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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