Cognitive and Motor Tasks in Cerebral Palsy | NCT04850690

Studies
Cognitive and Motor Tasks in Cerebral Palsy

NCT04850690

Sponsor

Istanbul Medipol University Hospital

Status

Completed

Last Update Posted

Apr 20, 2021Actual

Enrollment

15Actual

Phase

Not provided

Conditions

Cerebral Palsy
Gait Disorders, Neurologic
Cognitive Orientation
Motor Activity

Interventions

2D Gait analysis

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2018Actual

Primary Completion Date

May 1, 2019Actual

Completion Date

Jul 1, 2019Actual

First Submitted Date

Apr 14, 2021

First Submission Date that Met QC Criteria

Apr 15, 2021

First Posted Date

Apr 20, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2021

Last Update Posted Date

Apr 20, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

mbudak, Miray Budak, Istanbul Medipol University HospitalPrincipal Investigator

Lead Sponsor

Istanbul Medipol University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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:

Detailed 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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Children with hemiparetic Cerebral palsy		15 children with CP, between 9-15 years old	Diagnostic Test: 2D Gait analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
2D Gait analysis	Diagnostic Test	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
2D Gait analysis	Kinovea video analysis	through study completion, an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

15 children with Cerebral Palsy, between 9-15 years old

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Miray BUDAK, PhD	Medipol University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istanbul Medipol University		Istanbul	Beykoz	34815	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002547	Cerebral Palsy
D020233	Gait Disorders, Neurologic
D000072458	Orientation, Spatial
D009043	Motor Activity

Ancestor Terms

ID	Term
D001925	Brain Damage, Chronic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided