NCT06603636

Brief Summary

The study was applied to assess the difference of the foot progression angle and measuring spatiotemporal parameters of gait among the three age groups (five to six, six to seven and seven to eight years), of diplegic cerebral palsied children and to investigate the relation between FPA of right and left lower extremity and spatiotemporal parameters of gait in diplegic cerebral palsied children. Sixty diplegic cerebral palsied children from both sexes with age ranged from five to eight years old were participated in this study. Children were selected from the outpatient clinic of faculty of physical therapy, Cairo University. They were divided into three equal age groups, group (A) from five to six years, group (B) from six to seven years and group (C) from seven to eight years. Foot progression angle and spatiotemporal parameters of gait were evaluated for each participated child by the use of dynamic footprint during walking barefoot at free walking speed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

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

May 15, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

February 5, 2025

Status Verified

February 1, 2025

Enrollment Period

1.1 years

First QC Date

September 7, 2024

Last Update Submit

February 1, 2025

Conditions

Keywords

Foot progression angleSpatiotemporalDynamic footprint

Outcome Measures

Primary Outcomes (1)

  • foot progression angle

    Foot progression angle of both right and left foot

    up to 4 months

Study Arms (1)

study group

cerebral palsy children aging from 5 to 8 years having problem in gait

Eligibility Criteria

Age5 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

this study were to determine the side differences (right and left sides) on FPA values in diplegic CP children and to measuring spatiotemporal parameters of gait (step length, stride length, speed, cadence, single leg support) in diplegic CP children from five to eight years and to investigate the relation between foot progression angle of right and left lower extremity and spatiotemporal parameters of gait in diplegic cerebral palsied children. The study applied at the out clinic of faculty of physical therapy Cairo university

You may qualify if:

  • Their age will be ranged from six to eight years.
  • Children diagnosed as diplegic and/or hemiplegic CP.
  • Children who can stand and ambulate without the use of an assistive device (At Level II or III on the Gross Motor Function Classification System).
  • Their degree of spasticity will be ranged from 1 to 1+ according to the Modified Ashworth Scale.
  • Children who are able to follow instructions and understand commands given to them during the testing procedure.
  • Dynamic foot print will be used to assess FPA and spatial parameter of gait (step length and stride length).

You may not qualify if:

  • Children with Convulsions.
  • Children with fixed contractures of lower extremities.
  • Children with surgical interventions in the lower extremities.
  • Children with visual and\\or auditory disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Giza, Dokki, 12611, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
10 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical researcher

Study Record Dates

First Submitted

September 7, 2024

First Posted

September 19, 2024

Study Start

May 15, 2023

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

February 5, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

research results research variables studied number of participants

Shared Documents
STUDY PROTOCOL
Time Frame
up to 1 months
Access Criteria
any one

Locations