Cerebral PalsyNCT03179124
Upper Extremity Function In Cerebral Palsy And Its Association With Balance And Trunk Control
An observational study of Cerebral Palsy, run by Gazi University.
Trial summary
Children with cerebral palsy (CP) have postural control problems due to the lack of motor and sensory development. Trunk control which has an important role in ensuring postural control, is the basis for sitting, mobility, development of the upper extremity, pulmonary function and activities of daily living. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Cerebral Palsy
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2016to 20 May 2017
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Cerebral palsy (CP) describes a group of permanent disorders in movement and posture that limit activity and participation and are attributed to non-progressive disturbances in the developing fetal or infant brain
Who may be able to join
- spastic hemiparetic and / or diparetic CP
- co-operative enough to understand test directives
- between 5 and 12 years of age
- Having spasticity of 0-2 according to the modified wax and / or modified Ashworth Scale (MAS)
- GMFCS I, II and III
Who cannot join
- Have had previous orthopedic surgery to the upper extremity
About this study
Children with cerebral palsy (CP) have postural control problems due to the lack of motor and sensory development. Trunk control which has an important role in ensuring postural control, is the basis for sitting, mobility, development of the upper extremity, pulmonary function and activities of daily living. Poor postural control restricts upper extremity functions which also affects the quality of movements. For this reason, it is important to assess the relationship between trunk control and upper extremity functions. This study is planned to investigate the effect of balance and trunk control on upper extremity functions in children with CP.
Read the detailed description
30 hemiparetic and 32 diparetic CP, in total 62 children, aged between 5-12 years, were included in this study. Trunk Control Measurement Scale (TCMS) was used to assess trunk control, Pediatric Balance Scale (PBS) was used to assess balance, and Quality of Upper Extremity Skills Test was used to assess upper extremity functions (QUEST).
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, trunk control, upper extremity
- Medical subject headings
- Cerebral Palsy
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 |
|---|---|---|
| Hemiparetic cerebral palsy | Unilateral paresis in which upper extremities are more severely affected than lower extremities. | |
| Diparetic cerebral palsy | Lower extremities were more affected than upper extremities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Upper Extremity Skills Test
QUEST is a reliable tool for children with CP aged 2-12 years.The QUEST groups upper limb movement into four domains. Each domain focuses on areas of difficulty typically seen in children with spastic cerebral palsy: (a) Dissociated Movements, (ability to voluntarily isolate movement at the shoulder, elbow, wrist and fingers); (b) Grasps (which also rates sitting postures during grasps of 1 inch cube, cereal, pencil or crayon); (c) Weight Bearing (ability to lean on the arms in prone or 4-point kneeling, sitting and while reaching); and (d) Protective Extension (using the arms to stop oneself from falling forward, backward and to the side). In addition to the four domains of movement the QUEST also has three scales: Hand Function, Spasticity and Co-operativeness.
Measured: 30 minutes
Secondary outcomes (2)
Pediatric Balance Scale
The PBS measure can be performed without specialized equipment and is quickly and easily administered. The PBS has been used to measure the balance functions for school-age children with mild-to-moderate motor impairments
Measured: 20 minutes
Trunk Control Measurement Scale
This scale consists of 15 items measuring two main components of trunk control: (a) a stable base of support (static sitting balance), and (b) an actively moving body segment (dynamic sitting balance). The subscale static sitting balance (items 1-5) evaluates the ability of the child to maintain a stable trunk posture during movements of upper and lower limbs. The section dynamic sitting balance is further divided into two subscales: selective movement control and dynamic reaching. The subscale selective movement control (items 6-12) measures selective trunk movements in the sagittal (flexion/extension), frontal (lateral flexion) and transverse (rotation) plane within the base of support. The subscale dynamic reaching (items 13-15) evaluates the performance of three reaching tasks, requiring active trunk movements beyond the base of support
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 posted7 Jun 2017
- Study start20 Jun 2016
- Primary completion20 Apr 2017
- Study completion20 May 2017
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Simsek, Gazi University
- Investigators
- Bülent Elbasan, Study chair, study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03179124
- Sponsor's protocol ID
- 214
- Status last verified
- Jun 2017
- First submitted
- 6 Jun 2017
- Last updated
- 7 Jun 2017
- 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 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper Extremity Function In Cerebral Palsy And Its Association With Balance And Trunk Control
- ClinicalTrials.gov ID
- NCT03179124
- Acronym / sponsor ID
- 214
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, trunk control, upper extremity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 20 Jun 2016 (actual)
- Primary completion
- 20 Apr 2017 (actual)
- Study completion
- 20 May 2017 (actual)
- First posted
- 7 Jun 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.
Children with cerebral palsy (CP) have postural control problems due to the lack of motor and sensory development. Trunk control which has an important role in ensuring postural control, is the basis for sitting, mobility, development of the upper extremity, pulmonary function and activities of daily living. Poor postural control restricts upper extremity functions which also affects the quality of movements. For this reason, it is important to assess the relationship between trunk control and upper extremity functions. This study is planned to investigate the effect of balance and trunk control on upper extremity functions in children with CP.
Detailed description
30 hemiparetic and 32 diparetic CP, in total 62 children, aged between 5-12 years, were included in this study. Trunk Control Measurement Scale (TCMS) was used to assess trunk control, Pediatric Balance Scale (PBS) was used to assess balance, and Quality of Upper Extremity Skills Test was used to assess upper extremity functions (QUEST).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemiparetic cerebral palsy | – | –Unilateral paresis in which upper extremities are more severely affected than lower extremities. |
| Diparetic cerebral palsy | – | –Lower extremities were more affected than upper extremities |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Cerebral palsy (CP) describes a group of permanent disorders in movement and posture that limit activity and participation and are attributed to non-progressive disturbances in the developing fetal or infant brain
Key inclusion criteria (5 listed)
- spastic hemiparetic and / or diparetic CP
- co-operative enough to understand test directives
- between 5 and 12 years of age
- Having spasticity of 0-2 according to the modified wax and / or modified Ashworth Scale (MAS)
- GMFCS I, II and III
Key exclusion criteria (1 listed)
- Have had previous orthopedic surgery to the upper extremity
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
Quality of Upper Extremity Skills Test
Time frame: 30 minutes
QUEST is a reliable tool for children with CP aged 2-12 years.The QUEST groups upper limb movement into four domains. Each domain focuses on areas of difficulty typically seen in children with spastic cerebral palsy: (a) Dissociated Movements, (ability to voluntarily isolate movement at the shoulder, elbow, wrist and fingers); (b) Grasps (which also rates sitting postures during grasps of 1 inch cube, cereal, pencil or crayon); (c) Weight Bearing (ability to lean on the arms in prone or 4-point kneeling, sitting and while reaching); and (d) Protective Extension (using the arms to stop oneself from falling forward, backward and to the side). In addition to the four domains of movement the QUEST also has three scales: Hand Function, Spasticity and Co-operativeness.
2 secondary outcomes
Pediatric Balance Scale
Time frame: 20 minutes
Trunk Control Measurement Scale
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 7 Jun 2017.
- 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.
Bülent Elbasan study chair
study chair
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by Gazi University.
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 1 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 7 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Quality of Upper Extremity Skills Test (time frame: 30 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 7 Jun 2017.