NCT07351292

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 6, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

January 10, 2026

Last Update Submit

January 19, 2026

Conditions

Keywords

Ultrasoundwhole-body vibrationknee range of motionfunctional abilitychildrenhemiplegiacerebral palsy

Outcome Measures

Primary Outcomes (2)

  • Active Knee Extension Range of Motion (ROM)

    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

    12 weeks

  • 2. Gross Motor Function

    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 1. = initiates 2. = partially completes 3. = completes

    12 weeks

Study Arms (2)

ultrasound group

EXPERIMENTAL

received therapeutic ultrasound prior to stretching

Device: ultrasound

whole body vibration group

EXPERIMENTAL

performed exercises on a vibrating platform before stretching

Device: whole body vibration

Interventions

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

ultrasound group

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.

whole body vibration group

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Cairo, 11432, Egypt

Location

MeSH Terms

Conditions

Cerebral PalsyHemiplegia

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • mostafa S ali, PhD

    associate professor for pediatrics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Masking Description
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Model Description
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

January 10, 2026

First Posted

January 20, 2026

Study Start

March 6, 2025

Primary Completion

April 30, 2025

Study Completion

August 12, 2025

Last Updated

January 21, 2026

Record last verified: 2026-01

Locations