Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05640622
Other study ID # E-77082166-604.01.02-487509
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 15, 2022
Est. completion date August 1, 2023

Study information

Verified date August 2023
Source Gazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Most children with cerebral palsy (CP) can walk. Musculoskeletal disorders of these children cause deterioration in gait functions. Disruptions in gait limit children's participation. To minimize these impairments, various interventions are usually applied to children with CP who can walk. The ultimate goal of these interventions is to help these children achieve the best possible participation in activities of daily living. In addition, goal determination by children and families in treatment planning is important in terms of treatment success. The Gait Outcomes Assessment List (GOAL) is a scale developed to contribute to the determination of these goals. This questionnaire includes the priorities, expectations, and goals of children with CP who can walk and reveals their walking characteristics. The questionnaire is used in two languages, English and German, and there is no Turkish version of the questionnaire. Therefore, the aim of this study is to create the Turkish version of the 'Gait Outcomes Assessment List (GOAL)' family and child questionnaires and to examine its validity and reliability.


Recruitment information / eligibility

Status Completed
Enrollment 81
Est. completion date August 1, 2023
Est. primary completion date May 15, 2023
Accepts healthy volunteers No
Gender All
Age group 5 Years to 18 Years
Eligibility Inclusion Criteria: - Diagnosed with Cerebral Palsy - Being able to read and write Turkish Exclusion Criteria: - Children who have had botox or orthopedic surgery in the last 6 months

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Gait Outcomes Assessment List (GOAL)
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.

Locations

Country Name City State
Turkey Gazi University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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 O — View Citation

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Functional Mobility Scale (FMS) The FMS is a performance measure, classifying mobility on the basis of the use of mobility devices across three distances, 5m, 50m, and 500m, which represent home, school, and community distances. Assessment is by the clinician on the basis of questions asked of the parent or child. The mobility of the child is scored from 1 to 6 for each distance, with 1 representing the use of a wheelchair and 6 representing independence on all surfaces. 2 weeks
Secondary Gillette Functional Assessment Questionnaire (FAQ) The Gillette Functional Assessment Questionnaire (FAQ) is a self or proxy-report measure that includes a ten-level classification of ambulatory function (FAQ Walking Scale), and 22 functional locomotor activities rated on a five-level Likert difficulty scale (FAQ 22-item skill set). The FAQ 22-item skill set includes common functional mobility activities that further characterize the individual's locomotor abilities. The five-level Likert response scale used for the 22 skill items was 'easy', 'a little hard', 'very hard', 'can't do at all', and 'too young for activity'. 2 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05317234 - Genetic Predisposition in Cerebral Palsy N/A
Recruiting NCT05576948 - Natural History of Cerebral Palsy Prospective Study
Completed NCT04119063 - Evaluating Wearable Robotic Assistance on Gait Early Phase 1
Completed NCT03264339 - The Small Step Program - Early Intervention for Children With High Risk of Developing Cerebral Palsy N/A
Completed NCT05551364 - Usability and Effectiveness of the ATLAS2030 Exoskeleton in Children With Cerebral Palsy N/A
Completed NCT03902886 - Independent Walking Onset of Children With Cerebral Palsy
Recruiting NCT05571033 - Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy N/A
Not yet recruiting NCT04081675 - Compliance in Children With Cerebral Palsy Supplied With AFOs
Completed NCT02167022 - Intense Physiotherapies to Improve Function in Young Children With Cerebral Palsy N/A
Completed NCT04012125 - The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy N/A
Enrolling by invitation NCT05619211 - Piloting Movement-to-Music With Arm-based Sprint-Intensity Interval Training Among Children With Physical Disabilities Phase 1
Completed NCT04489498 - Comparison of Somatometric Characteristics Between Cerebral Palsy and Normal Children, Cross-sectional, Multi Center Study
Completed NCT03677193 - Biofeedback-enhanced Interactive Computer-play for Youth With Cerebral Palsy N/A
Recruiting NCT06450158 - Robot-assisted Training in Children With CP N/A
Completed NCT04093180 - Intensive Neurorehabilitation for Cerebral Palsy N/A
Completed NCT02909127 - The Pediatric Eating Assessment Tool
Not yet recruiting NCT06377982 - Human Umbilical Cord Blood Infusion in Patients With Cerebral Palsy Phase 1
Not yet recruiting NCT06007885 - Examining Capacity Building of Youth With Physical Disabilities to Pursue Participation Following the PREP Intervention. N/A
Not yet recruiting NCT03183427 - Corpus Callosum Size in Patients With Pineal Cyst N/A
Active, not recruiting NCT03078621 - Bone Marrow-Derived Stem Cell Transplantation for the Treatment of Cerebral Palsy Phase 1/Phase 2