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Clinical Determinants of the 6 Minute Walk Test in Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT03136432
Recruitment Status : Recruiting
First Posted : May 2, 2017
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Muserrefe Nur Keles, Gazi University

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.

Condition or disease
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 [Patient Registry]
Estimated Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Clinical Determinants of the 6 Minute Walk Test in Children With Cerebral Palsy
Actual Study Start Date : December 14, 2016
Estimated Primary Completion Date : December 15, 2018
Estimated Study Completion Date : March 15, 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Functional exercise capacity [ Time Frame: 20 minutes ]
    6 minute walk test


Secondary Outcome Measures :
  1. Respiratory muscle strength [ Time Frame: 20 minutes ]
    Mouth pressure device

  2. Activities of daily living using with Pediatric Evaluation of Disability Inventory [ Time Frame: 30 minutes ]
    PEDI scale

  3. Quality of life [ Time Frame: 30 minutes ]
    CPQOL scale

  4. Change in trunk control over time assessed with Trunk Control Measurement Scale [ Time Frame: 20 minutes ]
    Assessing change in trunk control



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Ages Eligible for Study:   7 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children with cerebral palsy who can walk independently continuously for 6 minutes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03136432


Contacts
Contact: Muserref KELES, Msc +905426622464 muserref-1@hotmail.com

Locations
Turkey
Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation Recruiting Ankara, Turkey, 06500 Active, not recruiting
Ankara, Turkey, 06500
Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation Recruiting
Ankara, Turkey, 06500
Contact: Muserref Nur Keles, Phd    +905426622464    muserref-1@hotmail.com   
Sponsors and Collaborators
Gazi University
Investigators
Study Chair: Bulent Elbasan, Phd Gazi University

Responsible Party: Muserrefe Nur Keles, Research Assistant, Gazi University
ClinicalTrials.gov Identifier: NCT03136432     History of Changes
Other Study ID Numbers: 8888
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: we have not decided yet

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Muserrefe Nur Keles, Gazi University:
Cerebral Palsy
Functional Exercise Capacity
Quality of Life

Additional relevant MeSH terms:
Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases