NCT03539523

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

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 2, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 16, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 29, 2018

Completed
Last Updated

May 30, 2018

Status Verified

May 1, 2018

Enrollment Period

Same day

First QC Date

May 16, 2018

Last Update Submit

May 27, 2018

Conditions

Keywords

L testcerebral palsychildrenvalidityreliability

Outcome Measures

Primary Outcomes (1)

  • L test

    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

    1 hour

Secondary Outcomes (1)

  • Timed Up and Go test

    10 minutes

Other Outcomes (1)

  • Timed Up and Down Stairs test

    10 minutes

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

children with cerebral palsy

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Kınıklı, 07100, Turkey (Türkiye)

Location

Related Publications (2)

  • Nguyen VC, Miller WC, Asano M, Wong RY. Measurement properties of the L test for gait in hospitalized elderly. Am J Phys Med Rehabil. 2007 Jun;86(6):463-8. doi: 10.1097/PHM.0b013e31805b8193.

  • Deathe AB, Miller WC. The L test of functional mobility: measurement properties of a modified version of the timed "up & go" test designed for people with lower-limb amputations. Phys Ther. 2005 Jul;85(7):626-35.

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
OTHER
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 16, 2018

First Posted

May 29, 2018

Study Start

January 2, 2018

Primary Completion

January 2, 2018

Study Completion

April 2, 2018

Last Updated

May 30, 2018

Record last verified: 2018-05

Locations