Cerebral PalsyNCT03951441
Construct Validity and Reliability SCALE
An observational study of Cerebral Palsy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to determine construct validity, discriminant validity and intra- and interrater reliability of the Selective Control Assessment of the Lower Extremity ( SCALE). Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Cerebral Palsy
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Oct 2017to 22 Jul 2019
- 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with Spastic Cerebral Palsy
Who may be able to join
- diagnosis of spastic cerebral palsy,
- age between 4 and 18 years,
- ability to follow simple instructions.
- ability to walk (GMFCS levels I-IV),
Who cannot join
- unstable situation regarding their tonus-regulating medications
- orthopedic intervention or surgical correction within the last year,
- botulinum toxin injection within the last 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University
Ankara, Sıhhiye, 06100
Merve Tunçdemir
About this study
Official title: Construct Validity and Reliability of the Selective Control Assessment of the Lower Extremity in Children With Cerebral Palsy
The aim of the study was to determine construct validity, discriminant validity and intra- and interrater reliability of the Selective Control Assessment of the Lower Extremity ( SCALE).
- Conditions
- Cerebral Palsy
- Keywords
- lower limb
- Medical subject headings
- Cerebral Palsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Selective Control Assessment of the Lower Extremity
SCALE examines SVMC in children with spastic CP. The SCALE tool assesses hip, knee, ankle, subtalar, and toe joints bilaterally.The SCALE tool assigns each joint a score from 0 to 2 points: 2 points, normal; 1 point, impaired; and 0 points, unable. The SCALE score is the sum of scoresfor each joint and assumes a 10 point maximum per limb.
Measured: 15 minutes
Secondary outcomes (4)
Gross Motor Function Classification System (GMFCS)
The GMFCS describes gross motor function in children with CP. It focuses on self-initiated movements, in particular sitting and walking. It is an age-related five-level system in which level I represents the least limitation and level V the most.
Measured: 2 minutes
Gross Motor Function Measurement (GMFM)
Gross Motor Function Measurement evaluates motor functions in children with Cerebral Palsy. There is 88 items under 5 subdimensions (lying and rolling, sitting, crawling and kneeling, standing, walking-running-jumping. GMFM has a 4-point scoring system for each item. The higher the child gets, the more successful the child is in gross motor functions.
Measured: 15 minutes
Modified Ashworth Scale (MAS)
Tone of lower extremity muscles will be assessed with Modified Ashworth Scale. The spasticity of each muscle ranged between 0 to 5. 0 means no increase in muscle tonus while 5 means that the joint is rigid due to the increase in excess tonus.
Measured: 5 minutes
The Physicians' Rating Scale (PRS)
The Physicians' Rating Scale is an observational tool that has been used to evaluate gait. PRS is assesses gait in the sagittal plane.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start9 Oct 2017
- Primary completion20 Jun 2019 (estimated)
- Study completion22 Jul 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 Hacettepe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve TUNÇDEMİR, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03951441
- Sponsor's protocol ID
- selectivemotorcontrol
- Status last verified
- May 2018
- First submitted
- 14 May 2019
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construct Validity and Reliability of the Selective Control Assessment of the Lower Extremity in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03951441
- Acronym / sponsor ID
- selectivemotorcontrol
- Conditions
- Cerebral Palsy
- Keywords
- lower limb
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 20 Jun 2019 (estimated)
- Study completion
- 22 Jul 2019 (estimated)
- First posted
- 15 May 2019 (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.
The aim of the study was to determine construct validity, discriminant validity and intra- and interrater reliability of the Selective Control Assessment of the Lower Extremity ( SCALE).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with Spastic Cerebral Palsy
Key inclusion criteria (4 listed)
- diagnosis of spastic cerebral palsy,
- age between 4 and 18 years,
- ability to follow simple instructions.
- ability to walk (GMFCS levels I-IV),
Key exclusion criteria (3 listed)
- unstable situation regarding their tonus-regulating medications
- orthopedic intervention or surgical correction within the last year,
- botulinum toxin injection within the last 6 months
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
Selective Control Assessment of the Lower Extremity
Time frame: 15 minutes
SCALE examines SVMC in children with spastic CP. The SCALE tool assesses hip, knee, ankle, subtalar, and toe joints bilaterally.The SCALE tool assigns each joint a score from 0 to 2 points: 2 points, normal; 1 point, impaired; and 0 points, unable. The SCALE score is the sum of scoresfor each joint and assumes a 10 point maximum per limb.
4 secondary outcomes
Gross Motor Function Classification System (GMFCS)
Time frame: 2 minutes
Gross Motor Function Measurement (GMFM)
Time frame: 15 minutes
Modified Ashworth Scale (MAS)
Time frame: 5 minutes
The Physicians' Rating Scale (PRS)
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
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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.
1 site 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, run by Hacettepe University at 1 site 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 4 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 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Merve Tunçdemir (00903123051576, merve.kd@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Selective Control Assessment of the Lower Extremity (time frame: 15 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 15 May 2019.