Clinical trial NCT06009354: Effectiveness of Education in Relaxation Surgeries
Official title: Effectiveness of Multi-Component Training in Lower Extremity Release Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 32
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will be carried out with volunteer patients who are followed up by the Orthopedics and Traumatology outpatient clinic of Muğla Training and Research Hospital and diagnosed with Cerebral Palsy and meet the study criteria. The evaluations will be performed in the Orthopedics and Traumatology outpatient clinic of Muğla Training and Research Hospital. This study was planned to investigate the effectiveness of multicomponent home activities and family child education against conventional postoperative practices in children with CP who underwent lower extremity tendon release surgery. Objective functional status, spasticity levels, pain levels, kinesiophobia levels and gait quality of the patients will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Children with walking CP between the ages of 4-18 years who have undergone lower extremity orthopedic surgery and at least 2 months have passed (leaving the acute and subacute period behind)
* Gross Motor Function Classification (GMFCS) level 1 (walks without restrictions), 2 (walks with restrictions) or 3 (walks using hand-held mobility aids)
* Understand simple commands
* Signing the consent form

Exclusion Criteria:

* Circumstances that would interfere with conducting assessments or communicating
* Lack of cooperation during the study
* Presence of severe mental retardation
* Presence of botulinum toxin application in the last 6 months

Primary outcomes:
measure: Tampa Scale for Kinesiophobia (TSK)
timeFrame: Change from Baseline TSK at 8 weeks
measure: Pain Catastrophising Scale (PCS)
timeFrame: Change from Baseline PCS at 8 weeks
measure: Timed Up and Go Test (TUG)
timeFrame: Change from Baseline TUG at 8 weeks
measure: One Leg Standing Test (OLST)
timeFrame: Change from Baseline OLST at 8 weeks
measure: Functional Reach Test (FRT)
timeFrame: Change from Baseline FRT at 8 weeks
measure: Gross Motor Function Classification System (GMFCS)
timeFrame: Change from Baseline GMFCS at 8 weeks
measure: Modified Ashworth Scale (MAS)
timeFrame: Change from Baseline MAS at 8 weeks
measure: Wong-Baker FACES Pain Rating Scale (WBFPRS)
timeFrame: Change from Baseline WBFPRS at 8 weeks
measure: FLACC Behavioral Pain Assessment scale
timeFrame: Change from Baseline FLACC at 8 weeks
measure: Wisconsin Gait Scale (WGS)
timeFrame: Change from Baseline WGS at 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Muğla
country: Turkey
facility: Muğla Sıtkı Koçman Training and Research Hospital
state: Menteşe
Study officials:
affiliation: Muğla Sıtkı Koçman University
name: Ahmet İmerci, MD
role: STUDY_DIRECTOR
affiliation: Muğla Sıtkı Koçman University
name: Fatih Özden, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Süleyman Demirel University
name: İsmet Tümtürk, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Muğla Sıtkı Koçman University
name: İsmet Uysal, PhD
role: PRINCIPAL_INVESTIGATOR
References: