Calf Muscle Strength and Standing Efficiency in Children With Spastic Diplegia

February 2, 2015 updated by: Ahmed Mohamed Elsayed Elnahhas, Cairo University

CALF MUSCLE STRENGTH AND STANDING EFFICIENCY IN CHILDREN WITH SPASTIC DIPLEGIA: A RANDOMIZED CONTROLLED TRIAL

It will be hypothesized that strengthening the calf muscles will improve standing efficiency in children with spastic diplegia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Giza
      • Cairo, Giza, Egypt
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children age will be ranging between 2 and 4 years.
  • They are classified at level III by GMFCS-ER, i.e. they can stand with minimal support.
  • Full mobile lower limbs joints.
  • Children with mild and moderate spasticity ( i.e. grade 1 and 2, according to Modified Ashworth Scale).

Exclusion Criteria:

  • Children with severe spasticity ( i.e. grade 4, according to Modified Ashworth Scale).
  • Fixed deformities.
  • Uncontrolled seizures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: calf muscle strengthenig group

experimental group

will receive the same selected physical therapy program in addition to manual and mechanical strengthening exercises and electrical stimulation program for calf muscles of both lower limbs.
Other: Strengthening exercise + Electrical stimulation of calf muscle
Other: selected physical therapy program
Other: No calf muscle strengthening group

control group

will receive only the selected physical therapy program
Other: selected physical therapy program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Gross Motor Function Measure
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultrasonography
Time Frame: 2 months
To measure calf muscle thickness
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

April 3, 2014

First Submitted That Met QC Criteria

April 4, 2014

First Posted (Estimate)

April 7, 2014

Study Record Updates

Last Update Posted (Estimate)

February 4, 2015

Last Update Submitted That Met QC Criteria

February 2, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12345 (Danish Center for Healthcare Improvements)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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