NCT06600984

Brief Summary

This study investigates the effects of WBV on fascicle length, knee joint angle and function in children with spastic hemiplegic cerebral palsy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

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

July 22, 2023

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

11 days

First QC Date

September 14, 2024

Last Update Submit

September 17, 2024

Conditions

Keywords

Cerebral palsyFascicle lengthHemiplegiaRange of motionWhole body vibration

Outcome Measures

Primary Outcomes (3)

  • Knee range of motion

    Each child in both groups had their knee joint\'s extension angle measured before and after a 12-week therapy program began using an absolute + AxisTM Digital Goniometer

    12 weeks

  • Fascicle length of hamstring muscle

    The biceps femoris muscle\'s muscle fascicle length was measured at a frequency of 7.5 MHz using GE LOGIQ P6 ultrasonography equipment

    12 weeks

  • gross motor function

    Gross Motor Functional Measurement-88 : is a common principle-test designed to assess changes in function in various milestones for children with cerebral palsy 0 = does not initiate 1. = initiates 2. = partially completes 3. = completes

    12 weeks

Study Arms (2)

physical therapy group

EXPERIMENTAL

Control group: received a designed physical therapy program

Other: designed physiotherapy program

whole body vibration group

EXPERIMENTAL

experimental group: received a designed physical therapy program in addition to WBV for 12 weeks

Device: whole body vibrationOther: designed physiotherapy program

Interventions

On a vibration platform, the children went into a complete squat. The device was calibrated at a frequency of 30 Hz, an amplitude of 2 mm, and a duration of 5 minutes. After the vibration was turned on, the children were told to stay in the squatting position and to report any discomfort that could occur. The vibration automatically shut off after five minutes. The children then rested for a minute. Next, under the identical conditions as for the squatting position, they were instructed to stand on the vibration platform for five minutes with the therapist\'s assistance. Consequently, WBV was applied for a total of 10 minutes during each session.

Also known as: WBV
whole body vibration group

structured therapeutic exercise program that included neurodevelopmental approaches, balance exercises, milestone facilitation, stretching exercises, and postural reaction facilitation. The program was conducted for one hour each day, three days a week.

Also known as: physical therapy program
physical therapy groupwhole body vibration group

Eligibility Criteria

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

You may qualify if:

  • Ages varied from four to six years of both sex
  • hemiplegic CP children, were suffering from knee joint flexion deformity due to hamstring muscles tightness
  • Level I and II motor function, according to the Growth Motor Function Classification System (GMFC) expanded and revised
  • Degree of spasticity ranged from 1 to 2 according to modified Ashworth scale
  • All children received neuro-developmental techniques

You may not qualify if:

  • Other causes of knee flexion deformities
  • Previous history of orthopedic surgery in knee joint
  • Visual or auditory problems
  • Seizures
  • Sensory or perceptual deficits
  • Any acute illness at the time of collection of data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

mostafa ALI

Giza, Married, 12668, Egypt

Location

MeSH Terms

Conditions

Cerebral PalsyHemiplegia

Condition Hierarchy (Ancestors)

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

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
associated professor of pediatric physical therapy

Study Record Dates

First Submitted

September 14, 2024

First Posted

September 19, 2024

Study Start

July 22, 2023

Primary Completion

August 2, 2023

Study Completion

November 10, 2023

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations