Effectiveness of Education in Relaxation Surgeries

NCT ID: NCT06009354

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-22
• Study Completion Date: 2025-08-01

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Group

The study group will receive multi-component training in addition to the usual practices. In the multi-component training content, self-massage applications performed by the patient's relatives, joint range of motion applications for the extremities, respiratory training, issues to be considered in activities of daily living, training on the use of assistive devices and training on methods of coping with pain kinesiophobia will be given to the patient's relatives through a video.

Group Type: EXPERIMENTAL

Rehabilitation

Intervention Type: OTHER

The control group will receive post-operative usual practices. The study group will receive multi-component education in addition to the usual practices.

Control Group

The control group will receive the usual post-operative applications (elevation, rest, cold application, stretching).

Group Type: ACTIVE_COMPARATOR

Rehabilitation

Intervention Type: OTHER

The control group will receive post-operative usual practices. The study group will receive multi-component education in addition to the usual practices.

Interventions

Rehabilitation

The control group will receive post-operative usual practices. The study group will receive multi-component education in addition to the usual practices.

Intervention Type: OTHER

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Muğla Sıtkı Koçman University

OTHER

Sponsor Role: lead

Responsible Party

Fatih Ozden

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fatih Özden, PhD

Role: PRINCIPAL_INVESTIGATOR

Muğla Sıtkı Koçman University

Locations

Muğla

Muğla, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

CP gevşetme

Identifier Type: -

Identifier Source: org_study_id