Cerebral PalsyNCT03136432
Clinical Determinants of the 6 Minute Walk Test in Cerebral Palsy
An observational study of Cerebral Palsy and Exercise, run by Gazi University at 2 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Cerebral Palsy, Exercise
- How many people
- 25 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 14 Dec 2016to 15 Mar 2019
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with cerebral palsy who can walk independently continuously for 6 minutes
Who may be able to join
- 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
Who cannot join
- Active medical condition impairment (pneumonia etc.)
- Do not accommodate the study
- Do not want to attempt the study
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 1 recruiting
- Active, not recruiting
Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation Recruiting Ankara, Turkey, 06500
Ankara, 06500
- Recruiting
Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation
Ankara, 06500
Muserref Nur Keles, Phd, +905426622464, muserref-1@hotmail.com
About this study
Official title: 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.
Read the 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).
- Conditions
- Cerebral Palsy, Exercise
- Keywords
- Cerebral Palsy, Functional Exercise Capacity, Quality of Life
- Medical subject headings
- Cerebral Palsy, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children with cerebral palsy | Children with cerebral palsy, who can walking dependently and continuously for 6 minutes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional exercise capacity
6 minute walk test
Measured: 20 minutes
Secondary outcomes (4)
Respiratory muscle strength
Mouth pressure device
Measured: 20 minutes
Activities of daily living using with Pediatric Evaluation of Disability Inventory
PEDI scale
Measured: 30 minutes
Quality of life
CPQOL scale
Measured: 30 minutes
Change in trunk control over time assessed with Trunk Control Measurement Scale
Assessing change in trunk control
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start14 Dec 2016
- Primary completion15 Dec 2018 (estimated)
- Study completion15 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muserrefe Nur Keles, Gazi University
- Investigators
- Bulent Elbasan, Phd, Study chair, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136432
- Sponsor's protocol ID
- 8888
- Status last verified
- Sep 2018
- First submitted
- 25 Apr 2017
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: we have not decided yet
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Determinants of the 6 Minute Walk Test in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03136432
- Acronym / sponsor ID
- 8888
- Conditions
- Cerebral Palsy, Exercise
- Keywords
- Cerebral Palsy, Functional Exercise Capacity, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 14 Dec 2016 (actual)
- Primary completion
- 15 Dec 2018 (estimated)
- Study completion
- 15 Mar 2019 (estimated)
- First posted
- 2 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with cerebral palsy | – | –Children with cerebral palsy, who can walking dependently and continuously for 6 minutes. |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with cerebral palsy who can walk independently continuously for 6 minutes
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Active medical condition impairment (pneumonia etc.)
- Do not accommodate the study
- Do not want to attempt the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional exercise capacity
Time frame: 20 minutes
6 minute walk test
4 secondary outcomes
Respiratory muscle strength
Time frame: 20 minutes
Activities of daily living using with Pediatric Evaluation of Disability Inventory
Time frame: 30 minutes
Quality of life
Time frame: 30 minutes
Change in trunk control over time assessed with Trunk Control Measurement Scale
Time frame: 20 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
- Individual participant dataSharing planned: No. we have not decided yet
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bulent Elbasan, Phd study chair
Gazi University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Exercise, run by Gazi University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muserref KELES, Msc (+905426622464, muserref-1@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional exercise capacity (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2018.