Cerebral PalsyNCT03504787
Upper Extremity Selective Voluntary Motor Control in Children With Unilateral Cerebral Palsy
An observational study of Cerebral Palsy, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to determine upper extremity selective motor control (SMC) in Children with Unilateral Cerebral Palsy (CP). It was also aimed to determine the relationship between upper extremity SMC and upper extremity functions in unilateral CP. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cerebral Palsy
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Apr 2017to 25 Mar 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 6 to 18 years
- All sexes
- Child, Adult
Study population: Children with unilateral cerebral palsy.
Who may be able to join
- diagnosis of unilateral spastic CP,
- age between 5 and 18 years,
- ability to follow simple instructions.
Who cannot join
- significant ataxia or dystonia
- orthopedic intervention or botulinum toxin injection to the upper extremities in the last 6 months
- orthopedic problems or medical conditions that prevented children from participating in the assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Upper Extremity Selective Voluntary Motor Control in Children With Unilateral Cerebral Palsy and Its Association With Upper Extremity Function
The aim of the study was to determine upper extremity selective motor control (SMC) in Children with Unilateral Cerebral Palsy (CP). It was also aimed to determine the relationship between upper extremity SMC and upper extremity functions in unilateral CP.
Read the detailed description
Twenty-four unilateral CP participated in the study between the ages of 6 and 18 years. Children's manual skills classified with MACS. To assess the quality of the upper extremity, the Quality of Upper Extremity Skill Test (QUEST) which assessed four areas including dissociated movement, grasp, weight bearing and protective extension, was used. Upper extremity functions were assessed using the Jebsen Taylor Hand Function Test (JTT). The Selective Control of Upper Extremity Scale (SCUES) was used to evaluate the selective movements of the upper extremity. The SCUES evaluates the movement of the trunk during the upper limb movements and mirror movements via video recording.
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, upper extremity, selective motor control
- 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 Upper Extremity Scale (SCUES)
The SCUES evaluate for movement at each joint level: the presence of mirror movements, movement of additional joints the target or index joint, presence of trunk movement, dynamic motion less than passive ROM. Upper extremity joint levels and motions examined include the shoulder (abduction/adduction), elbow (flexion/extension), forearm (supination/pronation), wrist (flexion/extension), and fingers/thumb (grasp/release). A video camera is placed in front of a participant sitting on a table. The examiner demonstrate the desired motion to the participant, then passively moves the participant's joint in the desired planes. The participant is then asked to perform the same motion. This activity is graded by the examiner from the videotape. Evaluation lasts less than 15 minutes. 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 (2)
Jebsen Taylor Hand Function Test (JTT)
It is a standard test used to evaluate the general hand function of the person. Seven subsets of the test simulate hand function, which includes writing, simulated page turning, stacking checkers, simulated feeding and picking up small common objects, large light objects, large heavy objects
Measured: 10 minutes
Quality of Upper Extremity Skill Test (QUEST)
The QUEST evaluates the quality of the upper extremity to four areas; Dissociated Movement, Grasp, Weight Bearing and Protective Extension. A score of "yes" or "no" is given according to the completion of each movement or task. The four field scores are summed to achieve the total score. During evaluation, the child is not allowed to use any device in the upper extremity
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 posted20 Apr 2018
- Study start25 Apr 2017
- Primary completion25 Jan 2018
- Study completion25 Mar 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 24 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, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504787
- Sponsor's protocol ID
- 77082166-302.08.01
- Status last verified
- Apr 2018
- First submitted
- 10 Apr 2018
- Last updated
- 20 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper Extremity Selective Voluntary Motor Control in Children With Unilateral Cerebral Palsy and Its Association With Upper Extremity Function
- ClinicalTrials.gov ID
- NCT03504787
- Acronym / sponsor ID
- 77082166-302.08.01
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, upper extremity, selective motor control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 25 Apr 2017 (actual)
- Primary completion
- 25 Jan 2018 (actual)
- Study completion
- 25 Mar 2018 (actual)
- First posted
- 20 Apr 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 upper extremity selective motor control (SMC) in Children with Unilateral Cerebral Palsy (CP). It was also aimed to determine the relationship between upper extremity SMC and upper extremity functions in unilateral CP.
Detailed description
Twenty-four unilateral CP participated in the study between the ages of 6 and 18 years. Children's manual skills classified with MACS. To assess the quality of the upper extremity, the Quality of Upper Extremity Skill Test (QUEST) which assessed four areas including dissociated movement, grasp, weight bearing and protective extension, was used. Upper extremity functions were assessed using the Jebsen Taylor Hand Function Test (JTT). The Selective Control of Upper Extremity Scale (SCUES) was used to evaluate the selective movements of the upper extremity. The SCUES evaluates the movement of the trunk during the upper limb movements and mirror movements via video recording.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children with unilateral cerebral palsy.
Key inclusion criteria (3 listed)
- diagnosis of unilateral spastic CP,
- age between 5 and 18 years,
- ability to follow simple instructions.
Key exclusion criteria (3 listed)
- significant ataxia or dystonia
- orthopedic intervention or botulinum toxin injection to the upper extremities in the last 6 months
- orthopedic problems or medical conditions that prevented children from participating in the assessment
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 Upper Extremity Scale (SCUES)
Time frame: 10 minutes
The SCUES evaluate for movement at each joint level: the presence of mirror movements, movement of additional joints the target or index joint, presence of trunk movement, dynamic motion less than passive ROM. Upper extremity joint levels and motions examined include the shoulder (abduction/adduction), elbow (flexion/extension), forearm (supination/pronation), wrist (flexion/extension), and fingers/thumb (grasp/release). A video camera is placed in front of a participant sitting on a table. The examiner demonstrate the desired motion to the participant, then passively moves the participant's joint in the desired planes. The participant is then asked to perform the same motion. This activity is graded by the examiner from the videotape. Evaluation lasts less than 15 minutes. 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
2 secondary outcomes
Jebsen Taylor Hand Function Test (JTT)
Time frame: 10 minutes
Quality of Upper Extremity Skill Test (QUEST)
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 20 Apr 2018.
- Individual participant dataSharing planned: No
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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 study chair
Gazi University
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 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 3 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: finished, as of the sponsor's last update on 20 Apr 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 Upper Extremity Scale (SCUES) (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 20 Apr 2018.