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Calf Muscle Strength and Standing Efficiency in Children With Spastic Diplegia

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ClinicalTrials.gov Identifier: NCT02105649
Recruitment Status : Completed
First Posted : April 7, 2014
Last Update Posted : February 4, 2015
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed Elsayed Elnahhas, Cairo University

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

Condition or disease Intervention/treatment Phase
Cerebral Palsy Other: Strengthening exercise + Electrical stimulation of calf muscle Other: selected physical therapy program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CALF MUSCLE STRENGTH AND STANDING EFFICIENCY IN CHILDREN WITH SPASTIC DIPLEGIA: A RANDOMIZED CONTROLLED TRIAL
Study Start Date : April 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cerebral Palsy

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
No calf muscle strengthening group

control group

will receive only the selected physical therapy program

Other: selected physical therapy program



Primary Outcome Measures :
  1. Gross Motor Function Measure [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Ultrasonography [ Time Frame: 2 months ]
    To measure calf muscle thickness



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Ages Eligible for Study:   2 Years to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105649


Locations
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Egypt
Cairo University
Cairo, Giza, Egypt
Sponsors and Collaborators
Cairo University

Publications:
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Responsible Party: Ahmed Mohamed Elsayed Elnahhas, assistant lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT02105649     History of Changes
Other Study ID Numbers: 12345
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: February 2015
Keywords provided by Ahmed Mohamed Elsayed Elnahhas, Cairo University:
cerebral palsy
standing
strengthening
Additional relevant MeSH terms:
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Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases