L Test in Children With Cerebral Palsy

Completed

• Conditions: Cerebral Palsy

• Registration Number: NCT03539523
• Lead Sponsor: Pamukkale University

Brief Summary

The aim of the study was to investigation of the validity and reliability of the L test in children with cerebral palsy. Eighty children with CP with mean age of 11.60±3.85 (56 boys, 24 girls) were included in the study. ICC ((Intraclass Correlation Coefficient) was used to assess interclass, intraclass and test- retest validity of the L test. Two independent examiners made L test, for the inter-rater reliability, twice within 1 day for the test-retest reliability. The minimal clinical important difference at 95% confidence interval intra-class correlation coefficient and standard error of measurements were calculated. The correlations of L test with Timed up and Go Test (TUG) and Timed up and Down Stairs Test (TUDS) were assessed for concurrent validity.

Detailed Description

Inclusion criteria were: cerebral palsy diagnosis, absence of other diseases that may impact gait performance, ambulatory for at least 20 meters, maximum level 2 according to Gross Motor Function Classification System. Exclusion criteria were: difficulty in following the instructions, severe lower extremity pain that affects mobility, orthopedic surgery within the last 12 months, Bothulium toxin A injection for lower extremity within the last 3 months and walking with a physical assistance from another person. Informed consents were obtained from the parents of the participants for the trial. Assessments were conducted in a special training and rehabilitation center where children with cerebral palsy received regular treatments.

Study Timeline

• Study Start: 2018-01-02
• Primary Completion: 2018-01-02
• Study Completion: 2018-04-02
• Status Verified: 2018-05
• Study First Submitted: 2018-05-16
• Study First Submitted QC: 2018-05-25
• Last Update Submitted: 2018-05-27
• Study First Posted: 2018-05-29
• Last Update Posted: 2018-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• cerebral palsy diagnosis, absence of other diseases that may impact gait performance, ambulatory for at least 20 meters, maximum level 2 according to Gross Motor Function Classification System

Exclusion Criteria

• difficulty in following the instructions, severe lower extremity pain that affects mobility, orthopedic surgery within the last 12 months, Bothulium toxin A injection for lower extremity within the last 3 months and walking with a physical assistance from another person.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
L test	1 hour	The child sat down on a armchair with their back on the backrest, then got up from the chair with the start command, walked the L-shaped 10 meters (3m+7m), turned back, walked the same distance and sat down the chair again. Time lapsed was recorded in seconds

Secondary Outcome Measures

Name	Time	Method
Timed Up and Go test	10 minutes	The child got up from the chair with the start command, walked for 3 meters, turned around, walked back and sat down. The time between the start command and the moment of complete seated position was recorded in seconds

Trial Locations

Locations (1)

Pamukkale University; 🇹🇷 Denizli, Kınıklı, Turkey