L Test in Children With Cerebral Palsy
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| ClinicalTrials.gov Identifier: NCT03539523 |
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Recruitment Status :
Completed
First Posted : May 29, 2018
Last Update Posted : May 30, 2018
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Sponsor:
Pamukkale University
Information provided by (Responsible Party):
Sebahat Yaprak Cetin, Pamukkale University
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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.
| Condition or disease |
|---|
| Cerebral Palsy |
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 Type : | Observational [Patient Registry] |
| Actual Enrollment : | 71 participants |
| Observational Model: | Other |
| Time Perspective: | Other |
| Target Follow-Up Duration: | 1 Day |
| Official Title: | Investigation of the Validity and Reliability of the L Test in Children With Cerebral Palsy |
| Actual Study Start Date : | January 2, 2018 |
| Actual Primary Completion Date : | January 2, 2018 |
| Actual Study Completion Date : | April 2, 2018 |
Resource links provided by the National Library of Medicine
Primary Outcome Measures :
- 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 Outcome Measures :
- 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 Outcome Measures:
- 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.
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| Ages Eligible for Study: | 6 Years to 16 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
children with cerebral palsy
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03539523
Locations
| Turkey | |
| Pamukkale University | |
| Denizli, Kınıklı, Turkey, 07100 | |
Sponsors and Collaborators
Pamukkale University
Additional Information:
Publications of Results:
Publications of Results:
| Responsible Party: | Sebahat Yaprak Cetin, Principal investigator, Pamukkale University |
| ClinicalTrials.gov Identifier: | NCT03539523 |
| Other Study ID Numbers: |
60116787-020/78784 |
| First Posted: | May 29, 2018 Key Record Dates |
| Last Update Posted: | May 30, 2018 |
| Last Verified: | May 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Plan Description: | Shared during work writing |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Sebahat Yaprak Cetin, Pamukkale University:
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L test cerebral palsy children validity reliability |
Additional relevant MeSH terms:
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Paralysis Cerebral Palsy Neurologic Manifestations Nervous System Diseases |
Brain Damage, Chronic Brain Diseases Central Nervous System Diseases |