NCT05957783

Brief Summary

İntroduction The upper limb can be involved in children with cerebral palsy (CP), while the lower limb is more commonly affected. Little is known regarding the alterations in the upper limb kinematics after the orthopedic surgery of the lower extremity during gait. This study aimed to evaluate the differences in the upper limb kinematics in children with CP between preoperative and postoperative parameters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2023

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2023

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 24, 2023

Completed
Last Updated

July 24, 2023

Status Verified

July 1, 2023

Enrollment Period

2.3 years

First QC Date

May 4, 2023

Last Update Submit

July 16, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Upper extremity angle measure in the all gait phases.

    initial contact (1), loading (2), midstance (3), terminal stance (4), pre-swing (5), early swing (6), mid-swing (7), and terminal swing (8) phases in the sagittal plane, and the following angles were measured: wrist sagittal plane angle, elbow sagittal plane angle, shoulder sagittal plane angle, trunk sagittal plane angle and head sagittal plane angle. In the coronal plane, the videos were paused at initial contact and midstance, and the following angles were measured: shoulder coronal plane angle, trunk coronal plane angle and head coronal plane angle.

    2021-2023

Study Arms (3)

Group 1

Preoperative patient group with diplegic or hemiplegic cerebral palsy

Other: Cerebral palsy Gait analysis technique

Group 2

Postoperative patient group with diplegic or hemiplegic cerebral palsy

Other: Cerebral palsy Gait analysis technique

Control group

5-15 age healthy children.

Other: Cerebral palsy Gait analysis technique

Interventions

Visual gait analysis in cerebral palsy new technique

Control groupGroup 1Group 2

Eligibility Criteria

Age2 Years - 17 Years
Sexall(Gender-based eligibility)
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

children with hemiplegic and diplegic cerebral palsy and 5-15 age health children

You may qualify if:

  • children with hemiplegic and diplegic cerebral palsy
  • Presence of preoperative and postoperative walking records from the lower extremity in our archive

You may not qualify if:

  • upper extremity surgery
  • Video recording does not allow measurement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University

Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral PalsyGait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Fuat Bilgili

    Istanbul Univercity Istanbul Faculty of Medicine

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopaedical Surgeon Resident.

Study Record Dates

First Submitted

May 4, 2023

First Posted

July 24, 2023

Study Start

January 3, 2021

Primary Completion

April 10, 2023

Study Completion

April 13, 2023

Last Updated

July 24, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations