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

NCT05194319 | Completed

• 1 other identifier: SANKOO
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Diplegia; Upper Extremity Dysfunction; Quality of Life; Participation, Patient

Keywords

Upper Extremity Functions; Diparetic Cerebral Palsy; Quality of Life; Participation

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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.

  first day of assesment

Secondary Outcomes (4)

• 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 Arms (2)

1/Children with diparetic cerebral palsy

Children with diparetic cerebral palsy

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.

Other: All assessments of children (Demographic information, upper extremity skills, quality of life and participation levels)

Interventions

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. .

1/Children with diparetic cerebral palsy; 2/Healty control

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

diparetic cerebral palsy children between 6-15 years old and their healty peer aged children

You may qualify if:

• 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

You may not qualify if:

• Severe cognitive dysfunction or inability to communicate cognitively,
• Having a diagnosis of mental disability,
• Mothers are illiterate

Sponsors & Collaborators

• Sanko University: lead
• Kahramanmaras Sutcu Imam University: collaborator

Study Sites (1)

Outpatient Rehabilitation Center

Gaziantep, Sahinbey, 27090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy; Patient Participation

Interventions

Quality of Life

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Nevin Ergun, Proffessor

  Sanko University

  STUDY DIRECTOR

• Hatice Adıgüzel, PhD

  Kahramanmaras Sutcu Imam University

  STUDY CHAIR

• merve Kafa, PT

  Sanko University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Proffessor

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: January 18, 2022
• Study Start: November 15, 2021
• Primary Completion: January 30, 2022
• Study Completion: February 15, 2022
• Last Updated: April 11, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)