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Completed

NCT Number: NCT07351292

Ultrasound or Whole Body Vibration on Knee Motion and Function in CP

This study compared the efficacy of therapeutic ultrasound (US) and whole-body vibration (WBV) as adjuncts to a standardized passive stretching regimen on improving knee joint range of motion (ROM) and functional capacity in children with hemiplegic cerebral palsy (HCP).

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Key information

Conditions

Cerebral Palsy (CP) Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Hemiplegia Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo university

Cairo, 11432, Egypt

About this study

Sixty children with HCP, aged 4-6 years, were randomly assigned to one of two groups. Both groups received passive stretching of the hamstrings and plantar flexors three times per week for twelve weeks. The control group (US group) received therapeutic ultrasound prior to stretching, while the research group (WBV group) performed exercises on a vibrating platform before stretching. Active knee extension ROM was measured with a digital goniometer, and functional ability was assessed using the Gross Motor Function Measure-88 (GMFM-88) at baseline and post-intervention.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age from 4-6 years
  • knee flexion deformity due to hamstring tightness
  • Gross Motor Function Classification System (GMFCS) levels I or II
  • spasticity grade of 1 or 2 on the modified Ashworth Scale

Exclusion criteria

  • other causes of knee flexion deformity
  • previous orthopedic knee surgery
  • significant visual, auditory, or perceptual deficits
  • uncontrolled seizures; or acute illness

Treatment and study plan

Ultrasound

Device

Received continuous ultrasound (1 MHz, 1.0 W/cm², 5 min per hamstring) using a Chattanooga Intelect Mobile 2 unit with a medium-sized transducer head and coupling gel

Whole Body Vibration

Device

Performed exercises on a Power Plate Pro 5 vibration platform. Parameters were set to a frequency of 20 Hz and a fixed amplitude of 2 mm (peak-to-peak displacement). The child maintained a semi-squat posture (approximately 30 knee flexion) for two 5-minute bouts separated by a 1-minute rest.

Primary outcomes

  1. Active Knee Extension Range of Motion (ROM)

    Time frame: 12 weeks

    Measured using an Absolute + Axis™ Digital Goniometer. With the child supine and pelvis stabilized, the goniometer axis was aligned with the lateral femoral condyle. The stationary arm was aligned with the greater trochanter, and the moving arm with the lateral malleolus. The child was instructed to actively extend the knee as far as possible, and the angle was recorded. Three measurements were taken, and the average was used for analysis

  2. 2. Gross Motor Function

    Time frame: 12 weeks

    Assessed using the Gross Motor Function Measure-88 (GMFM-88), a validated observational tool for children with CP. A blinded assessor, not involved in the intervention, scored the children's performance. The Gross Motor Functional Measurement-88 used to measure function. The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. The scoring key is meant to be a general guideline. However, most of the items have specific descriptors for each score. It is imperative that the guidelines

    contained in the manual be used for scoring each item.

    SCORING KEY 0 = does not initiate

    • = initiates
    • = partially completes
    • = completes

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Comparative Study of Therapeutic Ultrasound and Whole-body Vibration as Adjuncts to Passive Stretching on Knee Joint Range of Motion and Functional Ability in Children With Hemiplegic Cerebral Palsy.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 20, 2026
Registry last updated
Jan 21, 2026

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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