NCT05640622

Brief Summary

The aim of this study is to investigate the reliability and validity of the Turkish Gait Outcomes Assessment List (GOAL) Questionnaire, in children with cerebral palsy (CP) with GMFCS level1, 2, and 3.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2022

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 7, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

December 29, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

November 28, 2022

Last Update Submit

December 28, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Gait Outcomes Assessment List (GOAL)

    The GOAL consists of 49 items grouped into seven domains: domain A, activities of daily living and independence; domain B, gait function and mobility; domain C, pain, discomfort, and fatigue; domain D, physical activities, sports, and recreation; domain E, gait pattern and appearance; domain F, use of braces and mobility aids; and domain G, body image and self-esteem. Domains A, B, D, and E consist of 6-point Likert scales changing from extremely difficult to no problem at all. Domain C consists of 5-point Likert scales changing from everyday to none of the time. Domains F and G, consist of 5-point Likert scales changing from very unhappy to very happy. Domain and total GOAL scores were calculated for each child and ranged from 0 (worst) to 100 (best).

    2 weeks

Secondary Outcomes (2)

  • Functional Mobility Scale (FMS)

    2 weeks

  • Gillette Functional Assessment Questionnaire (FAQ)

    2 weeks

Interventions

Gait Outcomes Assessment List (GOAL) is a scale developed to contribute to the determination of treatment goals. This questionnaire includes the priorities, expectations, and goals of children with CP who can walk and reveals their walking characteristics.

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Children with Cerebral Palsy with GMFCS level 1,2, and 3

You may qualify if:

  • Diagnosed with Cerebral Palsy
  • Being able to read and write Turkish

You may not qualify if:

  • Children who have had botox or orthopedic surgery in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

Location

Related Publications (2)

  • Thomason P, Tan A, Donnan A, Rodda J, Graham HK, Narayanan U. The Gait Outcomes Assessment List (GOAL): validation of a new assessment of gait function for children with cerebral palsy. Dev Med Child Neurol. 2018 Jun;60(6):618-623. doi: 10.1111/dmcn.13722. Epub 2018 Mar 24.

  • Bonfert MV, Jelesch E, Hartmann J, Koenig H, Warken B, Meuche A, Jung NH, Bernius P, Weinberger R, Sorg AL, von Kries R, Narayanan UG, Hoesl M, Berweck S, Schroeder AS. Test-Retest Reliability and Construct Validity of the German Translation of the Gait Outcome Assessment List (GOAL) Questionnaire for Children with Ambulatory Cerebral Palsy. Neuropediatrics. 2022 Apr;53(2):96-101. doi: 10.1055/s-0040-1722688. Epub 2021 Dec 21.

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, PT, Principal Investigator

Study Record Dates

First Submitted

November 28, 2022

First Posted

December 7, 2022

Study Start

November 15, 2022

Primary Completion

May 15, 2023

Study Completion

August 1, 2023

Last Updated

December 29, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations