NCT05749809

Brief Summary

The aim of this study is to examine the relationship between lower extremity selectivity and gait in children with cerebral palsy. 32 volunteer children with CP between the ages of 5-20 will participate in the study. The Selective Control Assessment of the Lower Extremity (SCALE) questionnaire will be used to assess lower extremity selectivity, and the Edinburgh observational gait scale will be used to assess gait. Both assessments are observational.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 19, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
29 days until next milestone

Study Start

First participant enrolled

March 30, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

1.3 years

First QC Date

February 19, 2023

Last Update Submit

September 11, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Edinburgh Visual Gait Score

    It consists of 17 items scored separately for the right and left lower extremities. Assessments include 6 anatomical levels: trunk, pelvis, hip, knee, ankle, and foot. These anatomical levels are evaluated in the sagittal, coronal and transverse planes. A 3-point ordinal scale is used for scoring. In scoring, a value of 0 indicates normal, a value of 1 indicates moderate deviation from normal, and a value of 2 indicates significant deviation from normal. The scores obtained by watching the camera recordings for each lower extremity are summed and a single score is obtained.

    Baseline

  • Selective Control Assessment of the Lower Extremity (SCALE)

    Evaluates the selective motor control of the lower extremities. It evaluates hip, knee, ankle, subtalar and finger joints bilaterally. Voluntary flexion and extension movements are observed to assess selective voluntary motor control at each joint. Except for the hip joint, which is tested in the side-lying position to allow adequate joint movement, the evaluation of other joints is made in the sitting position.

    Baseline

Eligibility Criteria

Age5 Years - 20 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Cerebral palsy

You may qualify if:

  • Between the ages of 5-20
  • Diagnosed with CP

You may not qualify if:

  • Medical complications that limit participation in assessments (for example, severe visual impairment)
  • Lower extremity surgery or botox surgery in the last 6 months
  • Mental problems that cannot understand the commands given

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Sciences, Tokat Gaziosmanpaşa University

Tokat Province, 60250, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 19, 2023

First Posted

March 1, 2023

Study Start

March 30, 2023

Primary Completion

June 30, 2024

Study Completion

July 30, 2024

Last Updated

September 13, 2023

Record last verified: 2023-09

Locations