NCT02105649

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 7, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

February 4, 2015

Status Verified

February 1, 2015

Enrollment Period

3 months

First QC Date

April 3, 2014

Last Update Submit

February 2, 2015

Conditions

Cerebral Palsy

Keywords

cerebral palsystandingstrengthening

Outcome Measures

Primary Outcomes (1)

  • Gross Motor Function Measure

    2 months

Secondary Outcomes (1)

  • Ultrasonography

    2 months

Study Arms (2)

calf muscle strengthenig group

EXPERIMENTAL

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 muscleOther: selected physical therapy program

No calf muscle strengthening group

OTHER

control group will receive only the selected physical therapy program

Other: selected physical therapy program

Interventions

Strengthening exercise + Electrical stimulation of calf muscleOTHER
calf muscle strengthenig group
selected physical therapy programOTHER
No calf muscle strengthening groupcalf muscle strengthenig group

Eligibility Criteria

Age2 Years - 4 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Giza Governorate, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 9489498BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

April 3, 2014

First Posted

April 7, 2014

Study Start

April 1, 2014

Primary Completion

July 1, 2014

Study Completion

August 1, 2014

Last Updated

February 4, 2015

Record last verified: 2015-02

Locations

EG(1)