Cerebral PalsyNCT03600597
Construct Validity and Reliability SCUES
An observational study of Cerebral Palsy and Upper Extremity Dysfunction, run by Gazi 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 of the Upper Extremity Scale (SCUES). Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Cerebral Palsy, Upper Extremity Dysfunction
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2017to 10 May 2018
- 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 3 to 18 years
- All sexes
- Child, Adult
Study population: Children with Unilateral Cerebral Play
Who may be able to join
- Ages between 3-18 years
- Diagnosed as Cerebral Palsy (Hemiplegia)
Who cannot join
- Participants with an unstable situation regarding their tonus-regulating medications
- Participants had a botulinum toxin injection within the last 6 months, or any surgical correction within the last year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Construct Validity and Reliability of the Selective Control of the Upper Extremity Scale 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 of the Upper Extremity Scale (SCUES).
Read the detailed description
This study included children diagnosed with unilateral cerebral palsy. Children's upper extremity-selective motor controls were evaluated by video recording. Manual Ability Classification System and Taylor Hand Function Test were used to determine upper extremity functions
- Conditions
- Cerebral Palsy, Upper Extremity Dysfunction
- Medical subject headings
- Cerebral Palsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Selective Control of the Extremity Scale
SCUES administration required patients to perform specific isolated movement patterns at the shoulder (abduction/adduction), elbow (flexion/extension), forearm (supination/pronation), wrist (flexion/extension), and fingers/ thumb (grasp/release). Presence of mirror movements, movement of additional joints and motion less than available ROM are graded for movement at each joint level. Motion at each of the five joint levels is graded on a four-point scale: no SMC, moderately diminished SMC, mildly diminished SMC, and normal SMC.
Measured: 10 minutes
Secondary outcomes (1)
Jebsen Taylor Hand Function Test
The JTT measures movement, speed and manual dexterity. The subtests to assess hand function included turning over cards, simulated feeding, picking up small common objects, stacking checkers, picking up large objects, and picking up large heavy objects. Each task completion time was limited to 2 minutes.
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 posted26 Jul 2018
- Study start10 Apr 2017
- Primary completion10 Mar 2018
- Study completion10 May 2018
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.
- 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
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Simsek, Gazi University
- Investigators
- Bulent Elbasan, Study chair, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03600597
- Sponsor's protocol ID
- 77082166-302.08.01-
- Status last verified
- Jul 2018
- First submitted
- 17 Jul 2018
- Last updated
- 27 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construct Validity and Reliability of the Selective Control of the Upper Extremity Scale in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03600597
- Acronym / sponsor ID
- 77082166-302.08.01-
- Conditions
- Cerebral Palsy, Upper Extremity Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 10 Mar 2018 (actual)
- Study completion
- 10 May 2018 (actual)
- First posted
- 26 Jul 2018 (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 of the Upper Extremity Scale (SCUES).
Detailed description
This study included children diagnosed with unilateral cerebral palsy. Children's upper extremity-selective motor controls were evaluated by video recording. Manual Ability Classification System and Taylor Hand Function Test were used to determine upper extremity functions
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children with Unilateral Cerebral Play
Key inclusion criteria (2 listed)
- Ages between 3-18 years
- Diagnosed as Cerebral Palsy (Hemiplegia)
Key exclusion criteria (2 listed)
- Participants with an unstable situation regarding their tonus-regulating medications
- Participants had a botulinum toxin injection within the last 6 months, or any surgical correction within the last year
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 of the Extremity Scale
Time frame: 10 minutes
SCUES administration required patients to perform specific isolated movement patterns at the shoulder (abduction/adduction), elbow (flexion/extension), forearm (supination/pronation), wrist (flexion/extension), and fingers/ thumb (grasp/release). Presence of mirror movements, movement of additional joints and motion less than available ROM are graded for movement at each joint level. Motion at each of the five joint levels is graded on a four-point scale: no SMC, moderately diminished SMC, mildly diminished SMC, and normal SMC.
1 secondary outcome
Jebsen Taylor Hand Function Test
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2018.
Related trials for Cerebral Palsy
RecruitingPhase 2
The Progressive Supranuclear Palsy Clinical Trial Platform
Progressive Supranuclear Palsy(PSP)
Not yet recruiting
Ayres Sensory Integration Intervention for Children With Cerebral Palsy
Cerebral Palsy (CP)
Recruiting
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy
Recruiting
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
Brainstem Stroke, ALS
Not yet recruitingObservational study
Turkish Translation, Cross-Cultural Adaptation, Validity, and Reliability of the ABILHAND-Kids Young CP Scale
Cerebral Palsy
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 study chair
Study chair
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 and Upper Extremity Dysfunction, run by Gazi 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 27 Jul 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Selective Control of the Extremity Scale (time frame: 10 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 27 Jul 2018.