NCT06481722

Brief Summary

To determine if there is an effect of knee joint angle on muscle architecture in children with spastic cerebral palsy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 1, 2024

Completed
Last Updated

July 1, 2024

Status Verified

June 1, 2024

Enrollment Period

7 months

First QC Date

June 22, 2024

Last Update Submit

June 27, 2024

Conditions

Keywords

muscle architectureknee joint anglecerebral palsyspasticitychildren

Outcome Measures

Primary Outcomes (3)

  • Fascicle length

    Fascicle length will be measured by ultrasonography

    3 months

  • knee joint angle will be measured by digital Goniometer

    knee joint angle will be measured by digital Goniometer

    3 months

  • pennation angle

    pennation angle will be measured by ultrasonography

    3 months

Interventions

no intervention

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

To determine if there is an effect of knee joint angle on muscle architecture in children with spastic cerebral palsy, 40 diplegic cerebral palsy children of both sexes will participate in this study.

You may qualify if:

  • A diagnosis of spastic diplegia CP.
  • Age from 3 to 6 years.
  • Spasticity grade 1 and 1+ according to the Modified Ashworth scale.
  • Level III motor function according to the Growth Motor Function Classification System.
  • Hamstring muscle tightness.
  • Able to understand and follow instructions.

You may not qualify if:

  • Epilepsy.
  • Significant visual or auditory problems according to medical reports (audio-vestibular and ophthalmic examination).
  • Structural or fixed soft tissue deformities of the lower extremities.
  • Neurological or orthopedic surgery in the past 12 months.
  • Botox injection in the lower extremities in the past 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mostafa S Ali

Giza, Married, 12668, Egypt

Location

MeSH Terms

Conditions

Cerebral PalsyMuscle Spasticity

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor of pediatric physiotherapy, cairo university

Study Record Dates

First Submitted

June 22, 2024

First Posted

July 1, 2024

Study Start

April 10, 2023

Primary Completion

November 20, 2023

Study Completion

March 20, 2024

Last Updated

July 1, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations