Clinical trial NCT03136432: Clinical Determinants of the 6 Minute Walk Test in Cerebral Palsy
Official title: Clinical Determinants of the 6 Minute Walk Test in Children With Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Palsy
Exercise
Keywords: Cerebral Palsy
Functional Exercise Capacity
Quality of Life
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2017-05-02
Enrollment: 25
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with cerebral palsy who can walk independently continuously for 6 minutes

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).

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

Primary outcomes:
measure: Functional exercise capacity
timeFrame: 20 minutes
Secondary outcomes:
measure: Respiratory muscle strength
timeFrame: 20 minutes
measure: Activities of daily living using with Pediatric Evaluation of Disability Inventory
timeFrame: 30 minutes
measure: Quality of life
timeFrame: 30 minutes
measure: Change in trunk control over time assessed with Trunk Control Measurement Scale
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation Recruiting Ankara, Turkey, 06500
city: Ankara
country: Turkey
facility: Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation
Study officials:
affiliation: Gazi University
name: Bulent Elbasan, Phd
role: STUDY_CHAIR
References: