Quality of Life Clinical Trial
— CPOfficial title:
Determining the Effect of Upper Extremity Functional Skills on Quality of Life and Participation in Children With Diparetic Cerebral Palsy
NCT number | NCT05194319 |
Other study ID # | SANKOO |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 15, 2021 |
Est. completion date | February 15, 2022 |
Verified date | April 2022 |
Source | Sanko University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | February 15, 2022 |
Est. primary completion date | January 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 15 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - Severe cognitive dysfunction or inability to communicate cognitively, - Having a diagnosis of mental disability, - Mothers are illiterate |
Country | Name | City | State |
---|---|---|---|
Turkey | Outpatient Rehabilitation Center | Gaziantep | Sahinbey |
Lead Sponsor | Collaborator |
---|---|
Sanko University | Kahramanmaras Sutcu Imam University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | first day of assessment | |
Primary | 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. | first day of assessment | |
Primary | 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. | first day of assesment | |
Primary | Pediatric Outcome Data Collection Instrument (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. | first day of assesment | |
Secondary | demographic information | demographic information of the children and parents | first day of assessment | |
Secondary | 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. | first day of assessment | |
Secondary | 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. | first day of assessment | |
Secondary | 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. |
first day of assessment |
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