Calf Muscle Strength and Standing Efficiency in Children With Spastic Diplegia

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02105649
• Other study ID #: 12345
• Status: Completed
• Phase: N/A
• First received: April 3, 2014
• Last updated: February 2, 2015
• Start date: April 2014
• Est. completion date: August 2014

Study information

• Verified date: February 2015
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Cairo University
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 4 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Other:
• Strengthening exercise + Electrical stimulation of calf muscle

• selected physical therapy program

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Wiley ME, Damiano DL. Lower-extremity strength profiles in spastic cerebral palsy. Dev Med Child Neurol. 1998 Feb;40(2):100-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gross Motor Function Measure		2 months	Yes
Secondary	Ultrasonography	To measure calf muscle thickness	2 months	Yes