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Clinical Trials/NCT05194319
NCT05194319
Completed
Not Applicable

Determining the Effect of Upper Extremity Functional Skills on Quality of Life and Participation in Children With Diparetic Cerebral Palsy

Sanko University1 site in 1 country50 target enrollmentNovember 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Sanko University
Enrollment
50
Locations
1
Primary Endpoint
ABILHAND-Kids
Status
Completed
Last Updated
4 years ago

Overview

Brief 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. 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.

Registry
clinicaltrials.gov
Start Date
November 15, 2021
End Date
February 15, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Sanko University
Responsible Party
Principal Investigator
Principal Investigator

Hatice Adiguzel, PT

Assistant Proffessor

Sanko University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • demographic information(first day of assessment)
  • Manual Ability Classification System (MACS)(first day of assessment)
  • GMFCS (Gross Motor Function Classification System)(first day of assessment)
  • Modified Ashworth Scale(first day of assessment)

Study Sites (1)

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