Cerebral Palsy, SpasticNCT04231227
The Validity and Reliability of the Turkish Version of TASC and the Relationship Between SMC and Motor Functions
An observational study of Cerebral Palsy, Spastic and Cerebral Palsy, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Selective motor control (SMC) impairment in children with cerebral palsy (CP) includes movement patterns dominated by flexor or extensor synergy affecting functional movements. The research was designed to investigate the validity and the reliability of the Turkish version of the Test of Arm Selective Control (TASC)… Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Cerebral Palsy, Spastic, Cerebral Palsy, Cerebral Palsy Spastic Diplegia
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2018to 15 Jun 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 in Special Education Centers
Who may be able to join
- having a diagnosis of spastic CP
- being able to understand the commands required for the test,
- being between the ages of 3-18,
- being GMFCS level I to IV.
- Exclusion Criteria: • Having undergone orthopedic surgery or Botulinum Toxin A (BTX-A) within the last 6 months
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validity and Reliability of the Turkish Version of Test of Arm Selective Control and the Relationship Between Upper Limb Selective Motor Control and Motor Functions in Children With Cerebral Palsy
Selective motor control (SMC) impairment in children with cerebral palsy (CP) includes movement patterns dominated by flexor or extensor synergy affecting functional movements. The research was designed to investigate the validity and the reliability of the Turkish version of the Test of Arm Selective Control (TASC) (which is improved to evaluate SMC in children with spastic CP) and in order to provide more understanding of the relationship between SMC and upper extremity and gross motor functions. The study included 21 hemiplegic, 11 diplegic and 4 quadriplegic children with CP whose ages are 4 to 18 years and Gross Motor Function Classification System (GMFCS) level changes from 1 to 4, and their parents. In order to evaluate the gross motor function of children, GMFCS and the ability to hold objects with their hands in daily activities were evaluated with Manual Ability Classification System (MACS). ABILHAND-Kids scale was applied to evaluate upper extremity performance. TASC scale was used to evaluate the upper extremity SMC of children.
- Conditions
- Cerebral Palsy, Spastic, Cerebral Palsy, Cerebral Palsy Spastic Diplegia, Cerebral Palsy Quadriplegic, Cerebral Palsy, Monoplegic
- Keywords
- cerebral palsy, selective motor control, upper limb, upper limb functions, gross motor functions
- Medical subject headings
- Cerebral Palsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Test of Arm Selective Control
an upper limb selective motor control evaluation tool.
Measured: from July to September 2018
Abilhand- Kids Questionnaire
to assess a child's unimanual and bimanual upper limb activities
Measured: from July to September 2018
Manual Ability Classification System
to assess manual abilities of children
Measured: from July to September 2018
Gross Motor Function Classification System
To assess gross motor functions of children
Measured: from July to September 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 Jul 2018
- Primary completion30 Sep 2018
- Study completion15 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy, SpasticStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyma Kilcioglu, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231227
- Sponsor's protocol ID
- Upper Limb SMC in CP
- Status last verified
- Jan 2020
- First submitted
- 10 Jan 2020
- Last updated
- 18 Jan 2020
- 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 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Turkish Version of Test of Arm Selective Control and the Relationship Between Upper Limb Selective Motor Control and Motor Functions in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04231227
- Acronym / sponsor ID
- Upper Limb SMC in CP
- Conditions
- Cerebral Palsy, Spastic, Cerebral Palsy, Cerebral Palsy Spastic Diplegia, Cerebral Palsy Quadriplegic, Cerebral Palsy, Monoplegic
- Keywords
- cerebral palsy, selective motor control, upper limb, upper limb functions, gross motor functions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 15 Jun 2019 (actual)
- First posted
- 18 Jan 2020 (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.
Selective motor control (SMC) impairment in children with cerebral palsy (CP) includes movement patterns dominated by flexor or extensor synergy affecting functional movements. The research was designed to investigate the validity and the reliability of the Turkish version of the Test of Arm Selective Control (TASC) (which is improved to evaluate SMC in children with spastic CP) and in order to provide more understanding of the relationship between SMC and upper extremity and gross motor functions. The study included 21 hemiplegic, 11 diplegic and 4 quadriplegic children with CP whose ages are 4 to 18 years and Gross Motor Function Classification System (GMFCS) level changes from 1 to 4, and their parents. In order to evaluate the gross motor function of children, GMFCS and the ability to hold objects with their hands in daily activities were evaluated with Manual Ability Classification System (MACS). ABILHAND-Kids scale was applied to evaluate upper extremity performance. TASC scale was used to evaluate the upper extremity SMC of children.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children in Special Education Centers
Key inclusion criteria (5 listed)
- having a diagnosis of spastic CP
- being able to understand the commands required for the test,
- being between the ages of 3-18,
- being GMFCS level I to IV.
- Exclusion Criteria: • Having undergone orthopedic surgery or Botulinum Toxin A (BTX-A) within the last 6 months
Key exclusion criteria (0 listed)
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
Test of Arm Selective Control
Time frame: from July to September 2018
an upper limb selective motor control evaluation tool.
Abilhand- Kids Questionnaire
Time frame: from July to September 2018
to assess a child's unimanual and bimanual upper limb activities
Manual Ability Classification System
Time frame: from July to September 2018
to assess manual abilities of children
Gross Motor Function Classification System
Time frame: from July to September 2018
To assess gross motor functions of children
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 18 Jan 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, Spastic and 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 5 inclusion and 0 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 18 Jan 2020. 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?
Test of Arm Selective Control (time frame: from July to September 2018). The study lists 4 primary outcomes in all. 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 18 Jan 2020.