Clinical Determinants of the 6 Minute Walk Test in Cerebr... | NCT03136432

Studies
Clinical Determinants of the 6 Minute Walk Test in Cerebral Palsy

NCT03136432

Sponsor

Gazi University

Status

Unknown status

Last Update Posted

Sep 28, 2018Actual

Enrollment

25Estimated

Phase

Not provided

Conditions

Cerebral Palsy
Exercise

Interventions

Not provided

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

Sep 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 14, 2016Actual

Primary Completion Date

Dec 15, 2018Estimated

Completion Date

Mar 15, 2019Estimated

First Submitted Date

Apr 25, 2017

First Submission Date that Met QC Criteria

Apr 27, 2017

First Posted Date

May 2, 2017Actual

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

Sep 27, 2018

Last Update Posted Date

Sep 28, 2018Actual

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

Cerebral Palsy (CP) is a group of permanent disorders of movement and posture, generally accompanied by secondary musculoskeletal problems. Studies in literature showed taht children with CP supports a link between the levels of impairment and walking ability. The 6 Minute walk test is a standardized, self-placed walking test commonly used to access functional ability in children with cerebral palsy. While decreased exercise capacity has been identified in children with cerebral palsy, the clinical determinants of the 6MWT in this population have not been investigated yet. Thus the aim of this study is to investigate the relationship between 6 Minute walk test, quality of life, respiratory muscle strength,activities of daily living using with Pediatric Evaluation of Disability Inventory and trunk control.

Detailed Description

A convenience of children with hemiparetic and diplegia CP, 7-14 years, is going to recruited from Gazi University, Faculty of Health Science, Department of Physiotherapy and Rehabilitation. Every each of patients respiratory muscle strength will be evaluated using with electronic mouth pressure device, trunk control with using trunk control measurement scale, activities of daily living using with Pediatric Evaluation of Disability Inventory (PEDI), functional exercise capacity usin with six minute walk test (6MWT) and quality of life using with Cerebral Palsy Quality of Life Questionnaire (CPQOL).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Children with cerebral palsy		Children with cerebral palsy, who can walking dependently and continuously for 6 minutes.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Functional exercise capacity	6 minute walk test	20 minutes

Secondary Outcomes

Measure	Description	Time Frame
Respiratory muscle strength	Mouth pressure device	20 minutes
Activities of daily living using with Pediatric Evaluation of Disability Inventory	PEDI scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged 7-14 years
Diagnosed to spastic cerebral palsy
Gross Motor Function Classification System levels I or II.
Have no earlier interventions in the form of orthopaedic surgery or injection with botulinum toxin type A in the 6 month prior to baseline assessments
Child are able to demonstrate sufficient co-operation and cognitive understanding participating

Exclusion Criteria:

Active medical condition impairment (pneumonia etc.)
Do not accommodate the study
Do not want to attempt the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

14 Years

Standard Ages

Child

Study Population

Children with cerebral palsy who can walk independently continuously for 6 minutes

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Muserref KELES, Msc	Contact	+905426622464		muserref-1@hotmail.com

Overall Officials

Name	Affiliation	Role
Bulent Elbasan, Phd	Gazi University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation Recruiting Ankara, Turkey, 06500	Active, not recruiting	Ankara		06500	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

we have not decided yet

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002547	Cerebral Palsy
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

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Browse Branches

Not provided