Clinical Determinants of the 6 Minute Walk Test in Cerebral Palsy

Clinical Determinants of the 6 Minute Walk Test in Children With Cerebral Palsy

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.

Study Overview

• Status: Unknown
• Conditions: Cerebral Palsy; Exercise

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).

• Study Type: Observational
• Enrollment (Anticipated): 25

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06500
    • Active, not recruiting
    • Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation Recruiting Ankara, Turkey, 06500
  • Ankara, Turkey, 06500
    • Recruiting
    • Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation
    • Contact: Muserref Nur Keles, Phd; Phone Number: +905426622464; Email: muserref-1@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 14 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Children with cerebral palsy; Children with cerebral palsy, who can walking dependently and continuously for 6 minutes.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	30 minutes
Quality of life	CPQOL scale	30 minutes
Change in trunk control over time assessed with Trunk Control Measurement Scale	Assessing change in trunk control	20 minutes

Collaborators and Investigators

• Sponsor: Gazi University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 14, 2016
• Primary Completion (ANTICIPATED): December 15, 2018
• Study Completion (ANTICIPATED): March 15, 2019

Study Registration Dates

• First Submitted: April 25, 2017
• First Submitted That Met QC Criteria: April 27, 2017
• First Posted (ACTUAL): May 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 28, 2018
• Last Update Submitted That Met QC Criteria: September 27, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Cerebral Palsy; Quality of Life; Functional Exercise Capacity
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: 8888

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: we have not decided yet

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No