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Completed

NCT Number: NCT03539523

L Test in Children With Cerebral Palsy

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pamukkale University

Denizli, Kınıklı, 07100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. L test

    Time frame: 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 outcomes

  1. Timed Up and Go test

    Time frame: 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

Other outcomes

  1. Timed Up and Down Stairs test

    Time frame: 10 minutes

    A 10-step ladder was used for this test. The child was asked to climb up to the step at the top with the start command, turn back and climb down.

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

Investigation of the Validity and Reliability of the L Test in Children With Cerebral Palsy

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 29, 2018
Registry last updated
May 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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