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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04850690
Other study ID # CogMo-CP2021
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2018
Est. completion date July 1, 2019

Study information

Verified date April 2021
Source Istanbul Medipol University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Various gait deviations are observed in children with cerebral palsy. Our aim was to determine the effect of cognitive task (CT) and motor task (MT) on gait in children with cerebral palsy (CP). 15 children with CP, between 9-15 years old, with Communication Function Classification System (CFSS) level I, with Gross Motor Function Classification System (GMFCS) and Manual Ability Classification System (MACS) level I-II were included in the study. The gait with four different conditions (single gait, CT, MT and CT&MT) was evaluated by Kinovea video analysis method on a 10-meter course. Results:


Description:

All children with CP were instructed to walk on the track under four different conditions: - Single: Walking without task at a self-selected speed - Cognitive Task (CT): Walking while counting down rhythmically from 20 in threes - Motor Task (MT): Walking while carrying an empty box - CT + MT: Walking while carrying an empty box and counting down rhythmically from 20 in threes The task was explained to individuals by a physiotherapist. The individuals were not allowed to use orthosis during walking performance. Running was not accepted. 30 seconds were given to take a break between tasks. The physiotherapist followed the individuals along the track in case of any falling. If the child was not able to complete the track (falling or need to rest), the evaluation was accepted uncomplete and was excluded from the database. The Kinovea-08.15 software program was used to assess all of the outputs (images and videos) from the camera


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date July 1, 2019
Est. primary completion date May 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 9 Years to 15 Years
Eligibility Inclusion Criteria: - having been diagnosed with CP in the health committee - being between 9-15 years of age, having a mental level as "normal" (in terms of compliance with the exercises) - being in Gross Motor Function Classification System (GMFSC) Level I-II - being in Manual Ability Classification System (MACS) Level I-II - being in Communication Function Classification System (CFSS) Level I (communication method is speech). Exclusion Criteria: - having a mental retardation - having severe vision impairment - underwenting Botulinum Toxin (BOTOX) injection or surgery affecting lower extremities in the last 6 months.

Study Design


Intervention

Diagnostic Test:
2D Gait analysis
The gait with four different conditions (single gait, Cognitive Task, Motor Task and Cognitive Task&Motor Task) was evaluated by Kinovea video analysis method on a 10-meter course. Single: Walking without task at a self-selected speed Cognitive Task (CT): Walking while counting down rhythmically from 20 in threes Motor Task (MT): Walking while carrying an empty box CT + MT: Walking while carrying an empty box and counting down rhythmically from 20 in threes

Locations

Country Name City State
Turkey Istanbul Medipol University Istanbul Beykoz

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 2D Gait analysis Kinovea video analysis through study completion, an average of 1 year
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