Spastic Cerebral PalsyNCT05696535
Investigation of the Relationship Between Lower and Upper Extremity Selective Motor Control and Sensory Functions in Children With Spastic Cerebral Palsy
An observational study of Spastic Cerebral Palsy and Motor Activity, run by Mustafa Kemal University.
Trial summary
Although spasticity, contractures and muscle weakness in children with CP are disorders that can be observed more easily and are more focused and given more importance in evaluation and treatment approaches; Inadequate or loss of selective motor control negatively affects motor functions to a greater extent. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Spastic Cerebral Palsy, Motor Activity, Lower Extremity Problem
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Jun 2023
- 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
- Giving consent to participate in the study
- To be diagnosed with spastic type cerebral palsy;
- Being between the ages of 4-18;
- Being at level I-II-III according to the gross motor function classification system (GMFCS);
- Not having undergone Botulinum Toxin injection/lower-upper extremity surgery in the last 6 months
Who cannot join
- To be in level IV-V according to gross motor function classification system (GMFCS)
- Having severe mental retardation who does not understand verbal commands
About this study
Although spasticity, contractures and muscle weakness in children with CP are disorders that can be observed more easily and are more focused and given more importance in evaluation and treatment approaches; Inadequate or loss of selective motor control negatively affects motor functions to a greater extent.
It is very important to reveal the causes and consequences of selective motor disability in children with spastic cerebral palsy, in terms of creating effective treatment plans.
Read more
The number of patients to participate in the study was determined as 100. The study will be carried out in Hatay Mustafa Kemal University Research and Application Hospital, Department of Pediatrics.
In our study, demographic information will be filled in, and lower extremity selective control assessment scale (SCALE) for lower extremity, upper extremity selective control scale (SCUES) for upper extremity, and sensory assessment (touch, two-point discrimination and proprioceptive sensory assessment) will be performed on the patients who accepted the study.
- Medical subject headings
- Cerebral Palsy, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of selective motor control function
Measured: 2 months
Secondary outcomes (1)
The relationship between selective motor control and sensory functions
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study startJan 2023 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fırat Cicekli, Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696535
- Sponsor's protocol ID
- 22B058
- Status last verified
- Jan 2023
- First submitted
- 13 Jan 2023
- Last updated
- 25 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data entry is planned as patients are included in the study and data are collected. A timetable has not been foreseen yet.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Lower and Upper Extremity Selective Motor Control and Sensory Functions in Children With Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05696535
- Acronym / sponsor ID
- 22B058
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 25 Jan 2023 (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.
Although spasticity, contractures and muscle weakness in children with CP are disorders that can be observed more easily and are more focused and given more importance in evaluation and treatment approaches; Inadequate or loss of selective motor control negatively affects motor functions to a greater extent.
It is very important to reveal the causes and consequences of selective motor disability in children with spastic cerebral palsy, in terms of creating effective treatment plans.
The number of patients to participate in the study was determined as 100. The study will be carried out in Hatay Mustafa Kemal University Research and Application Hospital, Department of Pediatrics.
In our study, demographic information will be filled in, and lower extremity selective control assessment scale (SCALE) for lower extremity, upper extremity selective control scale (SCUES) for upper extremity, and sensory assessment (touch, two-point discrimination and proprioceptive sensory assessment) will be performed on the patients who accepted the study.
Study design
- Observational model
- Case only
- 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 (5 listed)
- Giving consent to participate in the study
- To be diagnosed with spastic type cerebral palsy;
- Being between the ages of 4-18;
- Being at level I-II-III according to the gross motor function classification system (GMFCS);
- Not having undergone Botulinum Toxin injection/lower-upper extremity surgery in the last 6 months
Key exclusion criteria (2 listed)
- To be in level IV-V according to gross motor function classification system (GMFCS)
- Having severe mental retardation who does not understand verbal commands
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
Evaluation of selective motor control function
Time frame: 2 months
1 secondary outcome
The relationship between selective motor control and sensory functions
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Individual participant dataSharing planned: Undecided. Data entry is planned as patients are included in the study and data are collected. A timetable has not been foreseen yet.
Related trials for Spastic Cerebral Palsy
Recruiting
Telerehabilitation Compared With Clinic-Based Physiotherapy in Children With Spastic Cerebral Palsy
Spastic Cerebral Palsy
Not yet recruiting
Video-based Visual Feedback Combined With Task-oriented Physiotherapy Among Cerebral Palsy
Cerebral Palsy (CP)
Recruiting
Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
Not yet recruitingObservational study
Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
Cerebral Palsy Infantile, Upper Limb Spasticity
Recruiting
Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy
Cerebral Palsy (CP), Unilateral Spastic 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Spastic Cerebral Palsy and Motor Activity, run by Mustafa Kemal 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 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: status not confirmed, as of the sponsor's last update on 25 Jan 2023. 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?
Results are not available in the source record.
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?
Evaluation of selective motor control function (time frame: 2 months). 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 25 Jan 2023.