Upper Extremity SpasticityNCT06585397
ICF-Based Evaluation of the Upper Extremity in Children With Quadriparetic Cerebral Palsy
An observational study of Upper Extremity Spasticity and Quadriplegic Cerebral Palsy, run by Acıbadem Atunizade Hospital at 1 site in Turkey (Türkiye).
Trial summary
Cerebral palsy (CP) is a neurodevelopmental disorder characterized by abnormalities in muscle tone, movement, and motor skills resulting from permanent, non-progressive damage to the developing brain before, during, or after birth. The worldwide prevalence of CP is 2-3 per 1000 live births. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Upper Extremity Spasticity, Quadriplegic Cerebral Palsy
- What is being tested?
- Grup 1
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to 1 Sep 2024
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Twenty quadriparetic children with CP, aged 0-17 years, will be included in the study for upper extremity evaluation.
Who may be able to join
- The age of the cases is between 0-17,
- They have been diagnosed with quadriparetic CP,
- The participants and parents want to participate in the study voluntarily.
Who cannot join
- Having different types of CP such as dyskinetic, ataxic and mixed type,
- Having spastic diparetic or hemiparetic type CP,
- Having any history of surgery on the musculoskeletal system,
- Having received Botulinum Toxin injection within the last 6 months.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Acıbadem Altunizade Hospital
Istanbul, AA, 34662
About this study
Cerebral palsy (CP) is a neurodevelopmental disorder characterized by abnormalities in muscle tone, movement, and motor skills resulting from permanent, non-progressive damage to the developing brain before, during, or after birth. The worldwide prevalence of CP is 2-3 per 1000 live births. Spastic CP accounts for approximately 85% of all CP cases. Among the types of spastic CP, quadriparetic CP (QCP) is the most severe and accounts for 20% of spastic CP cases. Individuals diagnosed with quadriparetic cerebral palsy (QCP) are restricted from participating in daily life activities due to inadequate upper extremity function (spasticity, muscle weakness, inability to perform isolated movements, and limitation of supination movements). In order to correctly evaluate children diagnosed with QCP and determine treatment priorities, it is very important to evaluate them based on the International Classification of Functioning, Disability, and Health (ICF). In the literature, there is no study that evaluates the upper extremity of individuals with isolated QCP based on ICF. The aim of this study is to examine the upper extremity functions of individuals with isolated QCP diagnosis within the framework of ICF.
Read the detailed description
It is an observational study. Purpose of the study: To examine the upper extremity functions of individuals with an isolated diagnosis of quadriparetic Cerebral Palsy (QCP) within the framework of ICF.
Participants: Children with quadriparetic CP between the ages of 0-17.
Questions:
- What is the relationship between upper extremity spasticity and manual dexterity in children with QCP?
- What is the relationship between manual skills and activities of daily living in children with QCP?
The upper extremities of the patients with QCP will be evaluated within the framework of ICF. Body structure and functions will be evaluated with the Modified Ashworth Scale (MAS), activities with the Manual Ability Classification System (MACS), and participation with the Functional Independence Measure for Children (WeeFIM). The evaluations will be made by physiotherapists experienced in children with CP.
- Being tested
- Grup 1
- Keywords
- ICF, Body structure and function, Activity, participation, cerebral palsy, upper extremity
- Medical subject headings
- Motor Activity, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grup 1Other
Within the framework of ICF, the Modified Ashworth Scale, the Manual Ability Classification System and the Functional Independence Measure for Children will be applied to 20 quadriparetic children with CP.
| Study group | Role | What they receive |
|---|---|---|
| Upper extremity evaluation of children with quadriparetic CP | Within the framework of ICF, the Modified Ashworth Scale, the Manual Ability Classification System and the Functional Independence Measure for Children will be applied to 20 quadriparetic children with CP. Receives: Other: Grup 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth Scale (MAS)
It is a 6-point scale that measures the resistance of the muscle to passive movement by passively moving it through the normal range of motion of the joint. Within the scope of the study, the upper extremity muscles; shoulder flexors, shoulder extensors, elbow flexors, elbow extensors, forearm pronators, wrist flexors, wrist extensors, and fingers will be evaluated with MAS.
Measured: baseline
Manual Ability Classification System (MACS)
It is used to classify how children with CP use their hands to handle objects in daily activities. The MACS identifies 5 levels. The MACS levels are functional descriptions based on a child's usual, self-initiated ability to handle objects in daily activities. The levels are based on children's ability to handle objects independently and their need for assistance or adaptations to perform manual activities in daily life.
Measured: baseline
Functional Independence Measure for Children (WeeFIM)
It was developed to assess the functional independence levels of children with developmental disabilities in their daily living activities. The scale consists of 6 sections: self-care (6 items), sphincter control (2 items), transfers (3 items), movement (2 items), communication (2 items), and social and cognitive status (3 items). There are a total of 18 items in the sections. All items in the sections are scored from 1 to 7. 1 point indicates full dependency; 7 points indicate full independence. A total of 18 (full dependency) points and a maximum of 126 (full independence) points can be obtained.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start1 Aug 2024
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Extremity SpasticityStudies 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acıbadem Atunizade Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neslihan Yildizdagi, Acıbadem Atunizade Hospital
- Investigators
- Neslihan Yıldızdağı, Principal investigator, Acıbadem Atunizade Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585397
- Sponsor's protocol ID
- Neslihan Yildizdagi
- Status last verified
- Sep 2024
- First submitted
- 3 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICF-Based Evaluation of the Upper Extremity in Children With Quadriparetic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06585397
- Acronym / sponsor ID
- Neslihan Yildizdagi
- Keywords
- ICF, Body structure and function, Activity, participation, cerebral palsy, upper extremity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Acıbadem Atunizade HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 5 Sep 2024 (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.
Cerebral palsy (CP) is a neurodevelopmental disorder characterized by abnormalities in muscle tone, movement, and motor skills resulting from permanent, non-progressive damage to the developing brain before, during, or after birth. The worldwide prevalence of CP is 2-3 per 1000 live births. Spastic CP accounts for approximately 85% of all CP cases. Among the types of spastic CP, quadriparetic CP (QCP) is the most severe and accounts for 20% of spastic CP cases. Individuals diagnosed with quadriparetic cerebral palsy (QCP) are restricted from participating in daily life activities due to inadequate upper extremity function (spasticity, muscle weakness, inability to perform isolated movements, and limitation of supination movements). In order to correctly evaluate children diagnosed with QCP and determine treatment priorities, it is very important to evaluate them based on the International Classification of Functioning, Disability, and Health (ICF). In the literature, there is no study that evaluates the upper extremity of individuals with isolated QCP based on ICF. The aim of this study is to examine the upper extremity functions of individuals with isolated QCP diagnosis within the framework of ICF.
Detailed description
It is an observational study. Purpose of the study: To examine the upper extremity functions of individuals with an isolated diagnosis of quadriparetic Cerebral Palsy (QCP) within the framework of ICF.
Participants: Children with quadriparetic CP between the ages of 0-17.
Questions:
- What is the relationship between upper extremity spasticity and manual dexterity in children with QCP?
- What is the relationship between manual skills and activities of daily living in children with QCP?
The upper extremities of the patients with QCP will be evaluated within the framework of ICF. Body structure and functions will be evaluated with the Modified Ashworth Scale (MAS), activities with the Manual Ability Classification System (MACS), and participation with the Functional Independence Measure for Children (WeeFIM). The evaluations will be made by physiotherapists experienced in children with CP.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Upper extremity evaluation of children with quadriparetic CP | – | Other: Grup 1Within the framework of ICF, the Modified Ashworth Scale, the Manual Ability Classification System and the Functional Independence Measure for Children will be applied to 20 quadriparetic children with CP. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Twenty quadriparetic children with CP, aged 0-17 years, will be included in the study for upper extremity evaluation.
Key inclusion criteria (3 listed)
- The age of the cases is between 0-17,
- They have been diagnosed with quadriparetic CP,
- The participants and parents want to participate in the study voluntarily.
Key exclusion criteria (4 listed)
- Having different types of CP such as dyskinetic, ataxic and mixed type,
- Having spastic diparetic or hemiparetic type CP,
- Having any history of surgery on the musculoskeletal system,
- Having received Botulinum Toxin injection within the last 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grup 1Within the framework of ICF, the Modified Ashworth Scale, the Manual Ability Classification System and the Functional Independence Measure for Children will be applied to 20 quadriparetic children with CP. | Other | Upper extremity evaluation of children with quadriparetic CP |
Primary outcome
Modified Ashworth Scale (MAS)
Time frame: baseline
It is a 6-point scale that measures the resistance of the muscle to passive movement by passively moving it through the normal range of motion of the joint. Within the scope of the study, the upper extremity muscles; shoulder flexors, shoulder extensors, elbow flexors, elbow extensors, forearm pronators, wrist flexors, wrist extensors, and fingers will be evaluated with MAS.
Manual Ability Classification System (MACS)
Time frame: baseline
It is used to classify how children with CP use their hands to handle objects in daily activities. The MACS identifies 5 levels. The MACS levels are functional descriptions based on a child's usual, self-initiated ability to handle objects in daily activities. The levels are based on children's ability to handle objects independently and their need for assistance or adaptations to perform manual activities in daily life.
Functional Independence Measure for Children (WeeFIM)
Time frame: baseline
It was developed to assess the functional independence levels of children with developmental disabilities in their daily living activities. The scale consists of 6 sections: self-care (6 items), sphincter control (2 items), transfers (3 items), movement (2 items), communication (2 items), and social and cognitive status (3 items). There are a total of 18 items in the sections. All items in the sections are scored from 1 to 7. 1 point indicates full dependency; 7 points indicate full independence. A total of 18 (full dependency) points and a maximum of 126 (full independence) points can be obtained.
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 19 Sep 2024.
- Individual participant dataSharing planned: No. Individual participant data will not be made available to other researchers.
Related trials for Upper Extremity Spasticity
RecruitingPhase 4
Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
Centreal Neurological Condition, Acquired Brain Injury (Including Stroke)
Not yet recruitingObservational study
Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
Cerebral Palsy Infantile, Upper Limb Spasticity
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spasticity
Multiple Sclerosis Spasticity
RecruitingPhase 1
Shockwave for Elbow and Wrist Spasticity in People With Spinal Cord Injury
Spinal Cord Injury, Spasticity
Active, not recruitingPhase 3
Study to Compare the Efficacy and Safety of NT 201 (Botulinum Toxin) With Placebo for the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury
Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury
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.
Neslihan Yıldızdağı principal investigator
Acıbadem Atunizade Hospital
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 Upper Extremity Spasticity and Quadriplegic Cerebral Palsy, run by Acıbadem Atunizade Hospital 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 4 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 19 Sep 2024. 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?
Modified Ashworth Scale (MAS) (time frame: baseline). The study lists 3 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 19 Sep 2024.