Clinical trial NCT05194319: Effect of Upper Extremity Functional Skills on Quality of Life and Participation of the Children With Cerebral Palsy
Official title: Determining the Effect of Upper Extremity Functional Skills on Quality of Life and Participation in Children With Diparetic Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Diplegia
Upper Extremity Dysfunction
Quality of Life
Participation, Patient
Keywords: Upper Extremity Functions
Diparetic Cerebral Palsy
Quality of Life
Participation
Lead sponsor: Sanko University
Sponsor class: OTHER
Collaborators: name: Kahramanmaras Sutcu Imam University
First posted: 2022-01-18
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: diparetic cerebral palsy children between 6-15 years old and their healty peer aged children

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.

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

Primary outcomes:
measure: The Jebsen-Taylor Hand Function Test (JTHFT)
timeFrame: first day of assessment
measure: ABILHAND-Kids
timeFrame: first day of assessment
measure: Pediatric Quality of Life Inventory (PedsQL)
timeFrame: first day of assesment
measure: Pediatric Outcome Data Collection İnstrument (PODCI)
timeFrame: first day of assesment
Secondary outcomes:
measure: demographic information
timeFrame: first day of assessment
measure: Manual Ability Classification System (MACS)
timeFrame: first day of assessment
measure: GMFCS (Gross Motor Function Classification System)
timeFrame: first day of assessment
measure: Modified Ashworth Scale
timeFrame: first day of assessment
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Outpatient Rehabilitation Center
state: Sahinbey
Study officials:
affiliation: Sanko University
name: Nevin Ergun, Proffessor
role: STUDY_DIRECTOR
affiliation: Kahramanmaras Sutcu Imam University
name: Hatice Adıgüzel, PhD
role: STUDY_CHAIR
affiliation: Sanko University
name: merve Kafa, PT
role: PRINCIPAL_INVESTIGATOR
References: