Clinical Determinants of the 6 Minute Walk Test in Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03136432
• Other study ID #: 8888
• Status: Recruiting
• Start date: December 14, 2016
• Est. completion date: March 15, 2019

Study information

• Verified date: September 2018
• Source: Gazi University
• Contact: Muserref KELES, Msc
• Phone: +905426622464
• Email: muserref-1[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: March 15, 2019
• Est. primary completion date: December 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Exercise
• Paralysis

Locations

Country	Name	City	State
Turkey	Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation	Ankara
Turkey	Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation Recruiting Ankara, Turkey, 06500	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional exercise capacity	6 minute walk test	20 minutes
Secondary	Respiratory muscle strength	Mouth pressure device	20 minutes
Secondary	Activities of daily living using with Pediatric Evaluation of Disability Inventory	PEDI scale	30 minutes
Secondary	Quality of life	CPQOL scale	30 minutes
Secondary	Change in trunk control over time assessed with Trunk Control Measurement Scale	Assessing change in trunk control	20 minutes