Cerebral PalsyCPNCT05194319
Effect of Upper Extremity Functional Skills on Quality of Life and Participation of the Children With Cerebral Palsy
An observational study of Cerebral Palsy and Diplegia, run by Sanko University at 1 site in Turkey (Türkiye).
Trial summary
Cerebral palsy (CP) is a movement and posture disorder accompanied by sensory, perception, cognition, communication and behavioral disorders that cause activity limitations by causing various non-progressive disorders of the fetal or infant brain. Read more about this study
- Who is it for?
- Ages 6 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Diplegia, Upper Extremity Dysfunction
- What is being tested?
- All assessments of children (Demographic information, upper extremity skills, quality of life and participation levels)
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2021to 15 Feb 2022
- 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 6 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: diparetic cerebral palsy children between 6-15 years old and their healty peer aged children
Who may be able to join
- To be between the ages of 6-15,
- Having the verbal communication ability to understand the evaluation materials and being willing to participate in the study (Written consent form will be obtained from the families), Being at the level of 1-3 when evaluated according to the GMFCS (Gross Motor Function Classification System),
- ≤ 2 in upper extremity muscles according to Modified Ashworth Scale (MASH)
- Being at 1-2 levels when evaluated according to MACS (Manual Ability Classification System),
- Absence of any contracture in the upper extremity
- Not having had any upper extremity surgery or Botulinum Toxin (Btx) in the last 6 months
Who cannot join
- Severe cognitive dysfunction or inability to communicate cognitively,
- Having a diagnosis of mental disability,
- Mothers are illiterate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Outpatient Rehabilitation Center
Gaziantep, Sahinbey, 27090
About this study
Official title: Determining the Effect of Upper Extremity Functional Skills on Quality of Life and Participation in Children With Diparetic Cerebral Palsy
Cerebral palsy (CP) is a movement and posture disorder accompanied by sensory, perception, cognition, communication and behavioral disorders that cause activity limitations by causing various non-progressive disorders of the fetal or infant brain. Spastic CP, according to the affected area in the body; It is classified as hemiparetic, diparetic and is observed most frequently. Diparetic CP, on the other hand, is characterized by significant spasticity in the pelvis and lower extremities, mild hypertonus or spasticity in the upper extremities, and incoordination, mostly involving the lower extremities and some upper extremities.Although lower extremity involvement is observed in different degrees in children with diparetic CP, studies showing how upper extremity and hand functions are affected are insufficient.The aim of this study is to compare the effect of upper extremity functional skills on quality of life and participation levels in children with diparetic CP with their healthy peers.
Read the detailed description
Cerebral palsy (CP) is a movement and posture disorder accompanied by sensory, perception, cognition, communication and behavioral disorders that cause activity limitations by causing various non-progressive disorders of the fetal or infant brain. Spastic CP, according to the affected area in the body; It is classified as hemiparetic, diparetic and is observed most frequently. Diparetic CP, on the other hand, is characterized by significant spasticity in the pelvis and lower extremities, mild hypertonus or spasticity in the upper extremities, and incoordination, mostly involving the lower extremities and some upper extremities. Although lower extremity involvement is observed in different degrees in children with diparetic CP, studies showing how upper extremity and hand functions are affected are insufficient.Upper extremity functions are one of the most important factors that ensure participation in daily life for these children. Hands play a key role in the execution of activities of daily living (ADL), as well as being among the most important components affecting upper extremity functionality.Children with spastic type CP experience limitations in mobility due to the decrease in selective motor control, and as a result, they may experience losses in social life and limitations in participation in their ADLs. These children have various functional disabilities such as various gait disorders, lower extremity contractures and strength losses, trunk and postural control deficiencies, mobility problems, vision problems, behavioral and sensory problems, upper extremity strength and skill losses that affect school success. This situation causes them to encounter difficulties in taking an active role in life.
Quality of life is a concept that shows the personal reactions to diseases that affect the level of personal satisfaction and to the physical, mental and social effects of daily life.Evaluation of quality of life in children with CP mostly includes physical symptoms, activity limitation, emotional stress, communication problems between child and family, limitation of school life, and determination of difficulties in the treatment of the disease. Decreased functional independence in children with CP compared to their healthy peers with typical development. Difficulties in activities of daily living, accompanying cognitive and sensory problems negatively affect quality of life.However, studies examining the relationship between upper extremity functional skills, quality of life and participation level in children with diparetic CP are insufficient in the literature.The aim of this study is to compare the effect of upper extremity functional skills on quality of life and participation levels in children with diparetic CP with their healthy peers.
- Conditions
- Cerebral Palsy, Diplegia, Upper Extremity Dysfunction, Quality of Life, Participation, Patient
- Being tested
- All assessments of children (Demographic information, upper extremity skills, quality of life and participation levels)
- Keywords
- Upper Extremity Functions, Diparetic Cerebral Palsy, Quality of Life, Participation
- Medical subject headings
- Cerebral Palsy, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All assessments of children (Demographic information, upper extremity skills, quality of life and participation levels)Other
The researcher will fill out the personal information form containing the descriptive characteristics of the parents and children. GMFCS to assess children's functional levels, Manual Ability Classification System (MACS) to assess hand skills, Modified Ashworth Scale for upper extremity muscle spasticity, for upper extremity functional skills; Jebson Taylor Test, Abilhand Kids scale, for Quality of Life; The Quality of Life Scale for Children (PedsQL), PODCI criterion for participation levels will be administered by a physiotherapist who has 2 years of experience in the profession and works in the field of pediatric rehabilitation. The Jebson Taylor test and spasticity classification will be applied directly to the child by the physiotherapist, but other scales will be filled in by the parents under the supervision of the physiotherapist. .
| Study group | Role | What they receive |
|---|---|---|
| 1/Children with diparetic cerebral palsy | Children with diparetic cerebral palsy Receives: Other: All assessments of children (Demographic information, upper extremity skills, quality of life and participation levels) | |
| 2/Healty control | Children with healty peer ages of cerebral palsy children. Receives: Other: All assessments of children (Demographic information, upper extremity skills, quality of life and participation levels) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Jebsen-Taylor Hand Function Test (JTHFT)
JTHFT evaulates the upper extremity functional skills.Jebsen Taylor Hand Function Test (JTHFT) is a test used between the ages of 6 and 90, administered between 15 and 45 minutes, consisting of 7 items, using a scaled board to ensure the standard arrangement of the objects used and a stopwatch to measure the time when the activities are done. Test materials; dessert spoon, bean grain, soda bottle cap, coin, checker stone, light and heavy tin can, pen and writing materials. Before the application, the child is shown how to make the items in the test. Explaining that the test is done against time is necessary for the motivation of the child. The child starts the activity with the start command and the stopwatch is stopped as soon as he/she finishes that activity. If he fails the activity, that part of the test is not continued. Increasing test completion time indicates worse hand function.
Measured: first day of assessment
ABILHAND-Kids
ABILHAND-Kids evaulates the assessment of upper extremity functional skills. Abilhand Kids is a 21-item functional test, mostly consisting of bimanual activities, answered by parents, assessing how children with CP aged 6-15 do their daily activities. With this questionnaire, parents evaluate the difficulty level of their children while doing an activity on a three-level scale as impossible, difficult and easy. Activities not done in the last 3 months are not scored within the scope of this survey and are considered as incomplete answers. Scores are '0 = Impossible', '1 = Difficult' and '2 = Easy'. A maximum of 42 points can be obtained in the test.
Measured: first day of assessment
Pediatric Quality of Life Inventory (PedsQL)
Pediatric Quality of Life Inventory (PedsQL) evaulates the quality of life of the children with cp. It consists of 23 items. It questions physical health, emotional functioning, social functionality and school functionality. Scoring is done in 3 areas. First, the total score of the scale, secondly the total score of physical health, and thirdly, the total score of psychosocial health, which consists of calculating the item scores evaluating emotional, social and school functionality, is calculated.Items are scored between 0-100. A score of 100 is scored if the answer is marked as never, 75 if it is marked as rarely, 50 if it is marked as sometimes, 25 if it is marked as often, and 0 if it is marked as almost always. As a result, the higher the total PedsQL score, the better the health-related quality of life is perceived.
Measured: first day of assesment
Pediatric Outcome Data Collection İnstrument (PODCI)
PODCI evaulates the participation level of the children with cp. The PODCI scale is used to determine the functional health status, physical functionality and participation level of children with CP. In addition to the evaluation of emotional and physical functions, it also reveals the expectations of families from the treatment applied to their children. The criterion can be applied to individuals aged 2-18 years. PODCI has 2 parent forms (child and adolescent) and adolescent form consisting of the same questions. The test is a Likert-type scale and consists of 6 sections: Upper Extremity Functions-UEF, Physical Function and Sports-FFS, Transfer and Basic Mobility-TM, Pain-RA, Happiness/Satisfaction-MM, and global function-GFR. Each of the sections is calculated from 0-100.
Measured: first day of assesment
Secondary outcomes (4)
demographic information
demographic information of the children and parents
Measured: first day of assessment
Manual Ability Classification System (MACS)
Manual Skills Classification System of the children with cp. MACS; It is a five-level system developed by Elliason et al. in 2003 to classify the ability to handle objects during daily activities in children with CP aged 4-18 years. The determination of the levels is based on the child's ability to hold objects to himself and the need for assistance and adaptation in performing manual activities in daily life. A higher score indicates worse hand function.
Measured: first day of assessment
GMFCS (Gross Motor Function Classification System)
Gross Motor Function Classification System of the children with cp. The main criterion while defining the five-level classification system is that the differences between the levels are meaningful in daily life. The differences are based on functional limitations, the need for hand-held mobility aids (walker, crutches, or canes) or wheeled mobility devices, and less so on the quality of movement. Higher level indicates worse functional level.
Measured: first day of assessment
Modified Ashworth Scale
Classification of spasticity of upper extremity muscles of children with CP.This scale was developed to measure muscle tone. The resistance to passive movement is evaluated. It is scored between 0-4.
0 No tone increase.
1 There is a slight increase in muscle tone. When the affected part is flexed or extended, minimal resistance is felt at the end of the movement or there is a catch-and-release sensation.
1+ Pulling sensation during movement, resistance felt in less than half of joint movement.
2 Resistance is felt during most of the joint movement, but the affected part is easily moved.
Passive movement is difficult throughout the 3 ROM. 4 The affected part is rigid in flexion or extension.
Measured: first day of assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start15 Nov 2021
- Primary completion30 Jan 2022
- Study completion15 Feb 2022
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
- 50 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Sanko University
- Sponsor type
- University, hospital or other
- Collaborators
- Kahramanmaras Sutcu Imam University
- Responsible party
- Principal investigator, Hatice Adiguzel, PT, Sanko University
- Investigators
- Nevin Ergun, Proffessor, Study director, Sanko UniversityHatice Adıgüzel, PhD, Study chair, Kahramanmaras Sutcu Imam Universitymerve Kafa, PT, Principal investigator, Sanko University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05194319
- Sponsor's protocol ID
- SANKOO
- Acronym
- CP
- Status last verified
- Apr 2022
- First submitted
- 3 Jan 2022
- Last updated
- 11 Apr 2022
- 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 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Effect of Upper Extremity Functional Skills on Quality of Life and Participation in Children With Diparetic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05194319
- Acronym / sponsor ID
- CP / SANKOO
- Conditions
- Cerebral Palsy, Diplegia, Upper Extremity Dysfunction, Quality of Life, Participation, Patient
- Keywords
- Upper Extremity Functions, Diparetic Cerebral Palsy, Quality of Life, Participation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sanko UniversityUniversity, hospital or other
- Collaborators
- Kahramanmaras Sutcu Imam University
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 18 Jan 2022 (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 movement and posture disorder accompanied by sensory, perception, cognition, communication and behavioral disorders that cause activity limitations by causing various non-progressive disorders of the fetal or infant brain. Spastic CP, according to the affected area in the body; It is classified as hemiparetic, diparetic and is observed most frequently. Diparetic CP, on the other hand, is characterized by significant spasticity in the pelvis and lower extremities, mild hypertonus or spasticity in the upper extremities, and incoordination, mostly involving the lower extremities and some upper extremities.Although lower extremity involvement is observed in different degrees in children with diparetic CP, studies showing how upper extremity and hand functions are affected are insufficient.The aim of this study is to compare the effect of upper extremity functional skills on quality of life and participation levels in children with diparetic CP with their healthy peers.
Detailed description
Cerebral palsy (CP) is a movement and posture disorder accompanied by sensory, perception, cognition, communication and behavioral disorders that cause activity limitations by causing various non-progressive disorders of the fetal or infant brain. Spastic CP, according to the affected area in the body; It is classified as hemiparetic, diparetic and is observed most frequently. Diparetic CP, on the other hand, is characterized by significant spasticity in the pelvis and lower extremities, mild hypertonus or spasticity in the upper extremities, and incoordination, mostly involving the lower extremities and some upper extremities. Although lower extremity involvement is observed in different degrees in children with diparetic CP, studies showing how upper extremity and hand functions are affected are insufficient.Upper extremity functions are one of the most important factors that ensure participation in daily life for these children. Hands play a key role in the execution of activities of daily living (ADL), as well as being among the most important components affecting upper extremity functionality.Children with spastic type CP experience limitations in mobility due to the decrease in selective motor control, and as a result, they may experience losses in social life and limitations in participation in their ADLs. These children have various functional disabilities such as various gait disorders, lower extremity contractures and strength losses, trunk and postural control deficiencies, mobility problems, vision problems, behavioral and sensory problems, upper extremity strength and skill losses that affect school success. This situation causes them to encounter difficulties in taking an active role in life.
Quality of life is a concept that shows the personal reactions to diseases that affect the level of personal satisfaction and to the physical, mental and social effects of daily life.Evaluation of quality of life in children with CP mostly includes physical symptoms, activity limitation, emotional stress, communication problems between child and family, limitation of school life, and determination of difficulties in the treatment of the disease. Decreased functional independence in children with CP compared to their healthy peers with typical development. Difficulties in activities of daily living, accompanying cognitive and sensory problems negatively affect quality of life.However, studies examining the relationship between upper extremity functional skills, quality of life and participation level in children with diparetic CP are insufficient in the literature.The aim of this study is to compare the effect of upper extremity functional skills on quality of life and participation levels in children with diparetic CP with their healthy peers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1/Children with diparetic cerebral palsy | – | Other: All assessments of children (Demographic information, upper extremity skills, quality of life and participation levels)Children with diparetic cerebral palsy |
| 2/Healty control | – | Other: All assessments of children (Demographic information, upper extremity skills, quality of life and participation levels)Children with healty peer ages of cerebral palsy children. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- diparetic cerebral palsy children between 6-15 years old and their healty peer aged children
Key inclusion criteria (6 listed)
- To be between the ages of 6-15,
- Having the verbal communication ability to understand the evaluation materials and being willing to participate in the study (Written consent form will be obtained from the families), Being at the level of 1-3 when evaluated according to the GMFCS (Gross Motor Function Classification System),
- ≤ 2 in upper extremity muscles according to Modified Ashworth Scale (MASH)
- Being at 1-2 levels when evaluated according to MACS (Manual Ability Classification System),
- Absence of any contracture in the upper extremity
Key exclusion criteria (3 listed)
- Severe cognitive dysfunction or inability to communicate cognitively,
- Having a diagnosis of mental disability,
- Mothers are illiterate
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 |
|---|---|---|
| All assessments of children (Demographic information, upper extremity skills, quality of life and participation levels)The researcher will fill out the personal information form containing the descriptive characteristics of the parents and children. GMFCS to assess children's functional levels, Manual Ability Classification System (MACS) to assess hand skills, Modified Ashworth Scale for upper extremity muscle spasticity, for upper extremity functional skills; Jebson Taylor Test, Abilhand Kids scale, for Quality of Life; The Quality of Life Scale for Children (PedsQL), PODCI criterion for participation levels will be administered by a physiotherapist who has 2 years of experience in the profession and works in the field of pediatric rehabilitation. The Jebson Taylor test and spasticity classification will be applied directly to the child by the physiotherapist, but other scales will be filled in by the parents under the supervision of the physiotherapist. . | Other | 1/Children with diparetic cerebral palsy, 2/Healty control |
Primary outcome
The Jebsen-Taylor Hand Function Test (JTHFT)
Time frame: first day of assessment
JTHFT evaulates the upper extremity functional skills.Jebsen Taylor Hand Function Test (JTHFT) is a test used between the ages of 6 and 90, administered between 15 and 45 minutes, consisting of 7 items, using a scaled board to ensure the standard arrangement of the objects used and a stopwatch to measure the time when the activities are done. Test materials; dessert spoon, bean grain, soda bottle cap, coin, checker stone, light and heavy tin can, pen and writing materials. Before the application, the child is shown how to make the items in the test. Explaining that the test is done against time is necessary for the motivation of the child. The child starts the activity with the start command and the stopwatch is stopped as soon as he/she finishes that activity. If he fails the activity, that part of the test is not continued. Increasing test completion time indicates worse hand function.
ABILHAND-Kids
Time frame: first day of assessment
ABILHAND-Kids evaulates the assessment of upper extremity functional skills. Abilhand Kids is a 21-item functional test, mostly consisting of bimanual activities, answered by parents, assessing how children with CP aged 6-15 do their daily activities. With this questionnaire, parents evaluate the difficulty level of their children while doing an activity on a three-level scale as impossible, difficult and easy. Activities not done in the last 3 months are not scored within the scope of this survey and are considered as incomplete answers. Scores are '0 = Impossible', '1 = Difficult' and '2 = Easy'. A maximum of 42 points can be obtained in the test.
Pediatric Quality of Life Inventory (PedsQL)
Time frame: first day of assesment
Pediatric Quality of Life Inventory (PedsQL) evaulates the quality of life of the children with cp. It consists of 23 items. It questions physical health, emotional functioning, social functionality and school functionality. Scoring is done in 3 areas. First, the total score of the scale, secondly the total score of physical health, and thirdly, the total score of psychosocial health, which consists of calculating the item scores evaluating emotional, social and school functionality, is calculated.Items are scored between 0-100. A score of 100 is scored if the answer is marked as never, 75 if it is marked as rarely, 50 if it is marked as sometimes, 25 if it is marked as often, and 0 if it is marked as almost always. As a result, the higher the total PedsQL score, the better the health-related quality of life is perceived.
Pediatric Outcome Data Collection İnstrument (PODCI)
Time frame: first day of assesment
PODCI evaulates the participation level of the children with cp. The PODCI scale is used to determine the functional health status, physical functionality and participation level of children with CP. In addition to the evaluation of emotional and physical functions, it also reveals the expectations of families from the treatment applied to their children. The criterion can be applied to individuals aged 2-18 years. PODCI has 2 parent forms (child and adolescent) and adolescent form consisting of the same questions. The test is a Likert-type scale and consists of 6 sections: Upper Extremity Functions-UEF, Physical Function and Sports-FFS, Transfer and Basic Mobility-TM, Pain-RA, Happiness/Satisfaction-MM, and global function-GFR. Each of the sections is calculated from 0-100.
4 secondary outcomes
demographic information
Time frame: first day of assessment
Manual Ability Classification System (MACS)
Time frame: first day of assessment
GMFCS (Gross Motor Function Classification System)
Time frame: first day of assessment
Modified Ashworth Scale
Time frame: first day of assessment
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 11 Apr 2022.
- 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.
Nevin Ergun, Proffessor study director
Sanko University
Hatice Adıgüzel, PhD study chair
Kahramanmaras Sutcu Imam University
merve Kafa, PT principal investigator
Sanko 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 and Diplegia, run by Sanko 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 6 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 11 Apr 2022. 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?
The Jebsen-Taylor Hand Function Test (JTHFT) (time frame: first day of assessment). 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 11 Apr 2022.