NCT06831591

Brief Summary

the investigators hypothesize that over time, it may lead to loss of functional capacity in children with CP. In this context, our study aims to examine the validity and reliability of the four-component Dubousset Functional Test (DFT), which is used to objectively measure the functional capacity of children with spastic CP, in children with spastic cerebral palsy at Gross Motor Function Classification System (GMFCS) I-II level.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2025

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

January 24, 2025

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 18, 2025

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

August 28, 2025

Status Verified

February 1, 2025

Enrollment Period

8 days

First QC Date

February 6, 2025

Last Update Submit

August 21, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Dubousset Functional Test

    Investigation of the Validity and Reliability of the Dubousset Functional Test in Children with GMFCS I-II Spastic Cerebral Palsy. It is a test used to objectively measure the functional capacity of children with spastic CP. The DFT includes 4 different test components. After the patients are administered the DFT, they will rest for 1 hour and then the DFT will be administered again. The time to complete the tests will be recorded in seconds and evaluated before and after.

    1 days

Secondary Outcomes (5)

  • TUG (Timed Up and Go) Test

    Day 1

  • Dual Task TUG (Additional Cognitive Task)

    Day 1

  • Three-Meter Backward Walk Test (3MBWT)

    day 1

  • Functional Reach Test

    day 1

  • Pediatric Balance Scale

    day 1

Study Arms (1)

gmfcs 1-2

It was conducted on individuals diagnosed with spastic CP at GMFCS level I-II.

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

G-Power 3.1.9.2 program was used to estimate the required sample size and it was observed that the effect obtained in the reference study was at a strong level (d = 0.731) (Lexell JE, Downham DY, 2005). As a result of the power analysis performed with the assumption that this effect size could be obtained again, it was calculated that 95% statistical power would be obtained at 95% confidence level if at least 33 people were included in the study.

You may qualify if:

  • years old,
  • Diagnosed with spastic cerebral palsy,
  • GMFCS level I-II,
  • At the appropriate cognitive level to adapt to the tests to be performed in the study,
  • Completed primary school level,
  • Individuals who agree to participate in the study will be recruited.

You may not qualify if:

  • Bone and/or soft tissue surgery on the lower extremities within the last 1 year,
  • Inability to perform a task due to sensory, cognitive or other problems,
  • Ataxic CP, Dyskinetic CP, Hypotonic CP, Mixed type CP groups will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kayseri City Hospital, Physical Medicine and Rehabilitation Clinic

Kayseri, 38000, Turkey (Türkiye)

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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

February 6, 2025

First Posted

February 18, 2025

Study Start

January 24, 2025

Primary Completion

February 1, 2025

Study Completion

March 1, 2025

Last Updated

August 28, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations