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Calf Muscle Strength and Standing Efficiency in Children With Spastic Diplegia

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Strengthening exercise + Electrical stimulation of calf muscle
selected physical therapy program
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring cerebral palsy, standing, strengthening

Eligibility Criteria

2 Years - 4 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

calf muscle strengthenig group

No calf muscle strengthening group

Arm Description

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.

control group will receive only the selected physical therapy program

Outcomes

Primary Outcome Measures

Gross Motor Function Measure

Secondary Outcome Measures

Ultrasonography
To measure calf muscle thickness

Full Information

First Posted
April 3, 2014
Last Updated
February 2, 2015
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT02105649
Brief Title
Calf Muscle Strength and Standing Efficiency in Children With Spastic Diplegia
Official Title
CALF MUSCLE STRENGTH AND STANDING EFFICIENCY IN CHILDREN WITH SPASTIC DIPLEGIA: A RANDOMIZED CONTROLLED TRIAL
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
cerebral palsy, standing, strengthening

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
calf muscle strengthenig group
Arm Type
Experimental
Arm Description
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.
Arm Title
No calf muscle strengthening group
Arm Type
Other
Arm Description
control group will receive only the selected physical therapy program
Intervention Type
Other
Intervention Name(s)
Strengthening exercise + Electrical stimulation of calf muscle
Intervention Type
Other
Intervention Name(s)
selected physical therapy program
Primary Outcome Measure Information:
Title
Gross Motor Function Measure
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Ultrasonography
Description
To measure calf muscle thickness
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Cairo University
City
Cairo
State/Province
Giza
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
9489498
Citation
Wiley ME, Damiano DL. Lower-extremity strength profiles in spastic cerebral palsy. Dev Med Child Neurol. 1998 Feb;40(2):100-7. doi: 10.1111/j.1469-8749.1998.tb15369.x.
Results Reference
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Calf Muscle Strength and Standing Efficiency in Children With Spastic Diplegia

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