Clinical Determinants of the 6 Minute Walk Test in Cerebral Palsy

NCT03136432 | Unknown DMC

• 1 other identifier: 8888
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 2

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.

Conditions

Cerebral Palsy; Exercise

Keywords

Cerebral Palsy; Functional Exercise Capacity; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Functional exercise capacity

  6 minute walk test

  20 minutes

Secondary Outcomes (4)

• Respiratory muscle strength

  20 minutes

• Activities of daily living using with Pediatric Evaluation of Disability Inventory

  30 minutes

• Quality of life

  30 minutes

• Change in trunk control over time assessed with Trunk Control Measurement Scale

  20 minutes

Study Arms (1)

Children with cerebral palsy

Children with cerebral palsy, who can walking dependently and continuously for 6 minutes.

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (2)

Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation Recruiting Ankara, Turkey, 06500

Ankara, 06500, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation

Ankara, 06500, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy; Motor Activity

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavior

Study Officials

• Bulent Elbasan, Phd

  Gazi University

  STUDY CHAIR

Central Study Contacts

Muserref KELES, Msc

CONTACT

+905426622464; muserref-1@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: April 25, 2017
• First Posted: May 2, 2017
• Study Start: December 14, 2016
• Primary Completion: December 15, 2018
• Study Completion: March 15, 2019
• Last Updated: September 28, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)