NCT05936554

Brief Summary

The study will be directed to compare which of whole body vibration (WBV) training and Functional strength training (FST) has better effect on balance in children with hemiparesis

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 24, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 7, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

July 8, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2023

Completed
Last Updated

October 30, 2023

Status Verified

October 1, 2023

Enrollment Period

4 months

First QC Date

June 24, 2023

Last Update Submit

October 26, 2023

Conditions

Keywords

cerebral palsyHemiparesisbalancewhole body vibrationfunctional strength training

Outcome Measures

Primary Outcomes (1)

  • balance improvement

    we will use pediatric balance scale and Biodex balance system to measure balance

    3 months

Secondary Outcomes (1)

  • gross motor performance

    3 months

Study Arms (2)

whole body vibration

ACTIVE COMPARATOR

will receive whole body Vibration training that elicits a warm up effect to improves muscle power and balance in addition to designed physical program.

Device: whole body vibration

Functional strength training

ACTIVE COMPARATOR

will receive Functional strength training that focuses on the movement pattern quality and treats functional movement and provides postural stability while promoting balance independence with confidence

Other: Functional strength training

Interventions

to improve muscle power and balance.

whole body vibration

used in treatment of hemiparetic cerebral palsy and provides postural stability while promoting balance independence with confidence and muscle power

Functional strength training

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • The children in the study will be selected according to the following criteria:
  • Their chronological age ranged from five to eight years old.
  • Spasticity Grade I and II according to Modified Ashworth Scale.
  • They will be on Level II and III according to Gross Motor Functional Classification System (GMFCS)
  • Have the ability to walk independently.
  • They can understand order and follow instruction.
  • The child will be able to follow verbal commands and instructions.
  • They can firmly grasp the rails of biodex device.

You may not qualify if:

  • Children with visual or auditory problems.
  • Children with uncontrolled convulsions.
  • Children with fixed contractures and deformities.
  • Children with surgical intervention less than one year.
  • Children injected by BOTOX in the calf muscle from less than one year.
  • Children had heart disease.
  • Children with epilepsy.
  • Children with severe diabetes.
  • Children with severe vascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy

Kafr ash Shaykh, Egypt

RECRUITING

MeSH Terms

Conditions

Cerebral PalsyParesis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Amany Ibrahim Abd Elhamed Sabra, Bachelor of physical therapy

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Bachelor's Degree of physical therapy

Study Record Dates

First Submitted

June 24, 2023

First Posted

July 7, 2023

Study Start

July 8, 2023

Primary Completion

October 27, 2023

Study Completion

October 27, 2023

Last Updated

October 30, 2023

Record last verified: 2023-10

Locations