NCT07096089

Brief Summary

Objectives: Children with cerebral palsy have weak proximal stability which not only affects range of available motion but also reflects on distal dexterity. These have a great impact on their mobility and efficiency of daily living activities. Vibration has been regarded as an effective exercise method to improve muscle strength and endurance. The aim of this study was to determine the effect of vibration on shoulder proximal stability in children with cerebral palsy. Methods: Fifty children with cerebral palsy from 4 to 9 years old participated in this study and were selected from the outpatient clinic of faculty of physical therapy. They were divided into two groups of equal sizes randomly. The control group received a conventional physical therapy program in addition to Sling exercise therapy, and the study group received the same conventional physical therapy program in addition to Sling exercise therapy (SET) and Whole-body vibration (WBV). Shoulder muscle strength was assessed for both groups by using Lafayette manual muscle tester before and after treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 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

October 10, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 31, 2025

Completed
Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

July 21, 2025

Last Update Submit

July 29, 2025

Conditions

Keywords

Cerebral palsyProximal stabilityShoulderWhole body vibration

Outcome Measures

Primary Outcomes (1)

  • Shoulder muscle strength

    Lafayette manual muscle tester In order to produce precise, objective, and dependable findings, the Lafayette Manual Muscle Tester (MMT) Model Number 01163 blends modern ergonomic design with accuracy and precision. The three cushioned stirrups that were interchangeable allowed for the confident and efficient use of recognized techniques while maintaining patient comfort. No other manual muscle test method uses the advancements found in the Lafayette MMT. The user may choose from an extensive array of variables through the interactive menus, including high and low threshold settings (to account for larger muscles or fingers), test periods ranging from one to ten seconds, and data storage. There is less chance of reading mistakes or selecting undesirable alternatives because of the wide, easy-to-read LCD screen that clearly shows all the information.

    4 to 6 months

Study Arms (2)

Conventional physical therapy program and Sling exercise therapy

EXPERIMENTAL

Conventional physical therapy program and Sling exercise therapy

Procedure: Conventional physical therapy program and Sling exercise therapy

Whole body vibration

EXPERIMENTAL

Whole body vibration

Procedure: Whole body vibration

Interventions

The control group received a conventional physical therapy program in addition to sling exercise therapy (SET) for 60 minutes.

Conventional physical therapy program and Sling exercise therapy

The study group received the same selected conventional physical therapy program in addition to sling exercise therapy (SET) given to the control group (for 30 minutes) besides whole body vibration (WBV) (for 30 minutes).

Whole body vibration

Eligibility Criteria

Age4 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children with cerebral palsy affecting weight bearing of the upper limbs.
  • Aged from 4 to 9 years.
  • Both gender participated.
  • Having grade 1 and 1+ spasticity according to the Modified Ashworth Scale.

You may not qualify if:

  • Congenital anomalies.
  • Surgical or neurological disease of the upper limbs.
  • Osteopenia or osteoporosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical therapy, Cairo University

Giza, Office Post Cairo University Giza, 12613, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Experimental trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer at Department of Physical Therapy for Paediatrics, Faculty of Physical Therapy, Cairo University, Cairo, Egypt.

Study Record Dates

First Submitted

July 21, 2025

First Posted

July 31, 2025

Study Start

October 10, 2023

Primary Completion

January 10, 2024

Study Completion

April 10, 2024

Last Updated

July 31, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations