search
Back to results

Effectiveness of Education in Relaxation Surgeries

Primary Purpose

Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Rehabilitation
Sponsored by
Muğla Sıtkı Koçman University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Muğla Sıtkı Koçman Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group

Control Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Tampa Scale for Kinesiophobia (TSK)
The questionnaire is a 17-item scale developed to measure fear of movement/reinjury. The normal score range is between 17 and 68.
Pain Catastrophising Scale (PCS)
Scale is used to assess the patient's feelings and thoughts about pain and disaster. The total score ranges from 0 to 52 points. A high score indicates a bad situation.
Timed Up and Go Test (TUG)
Participants sit in a chair with arms, hips and knees bent approximately 90◦ and feet resting on the floor. Lower limb orthoses are worn if used. Participants are asked to stand up, walk 10 steps, walk around a mark on the floor, walk back to the chair and sit down. The timing of the TUG test starts with the standing movement after the "ready, go" signal and ends when the participants are seated in the chair and the movement is finished.
One Leg Standing Test (OLST)
Children are tested standing on one leg using their right and left leg respectively. The test is repeated on a hard surface with eyes open and closed. The child is asked to place both hands on the hips and look at a target on the wall at eye level at a distance of 1 meter. The child is asked to stand with one leg while keeping the other leg in a 90 degree flexion position. A stopwatch is used to record the time the child can hold the test position. The examiner ends the test if the child can hold the position for more than 30 seconds and records the elapsed time.
Functional Reach Test (FRT)
The subject stands sideways next to a wall and flexes the shoulder 90 degrees. The 3rd metacarpal level is marked on the wall. The subject reaches as far as he/she can without taking a step. The 3rd metacarpal line is marked again. The difference between the marks is measured and noted.
Gross Motor Function Classification System (GMFCS)
The aim of this classification system is to provide a standardized classification of motor disability patterns in children with CP. It is a five-level ordinal grading system for classifying gross motor function in a child with CP, with level I representing the least limitation and level V the most limitation. At level I, children show mild involvement and can perform most of the activities of their peers. At level V, children show severe involvement, lacking head control and sitting balance.
Modified Ashworth Scale (MAS)
The Modified Ashworth Scale (MAS) is an indirect measure of the nature of spasticity. The MAS is a scale of perceived resistance (tone) to passive movement of the limb and is an adaptation of the original Ashworth Scale with the addition of the 1+ category.
Wong-Baker FACES Pain Rating Scale (WBFPRS)
The Wong-Baker FACES Pain Rating Scale shows six faces with increasing degrees of pain from left to right and each face is rated out of 10. 0 indicates no pain, 2 indicates a little pain, 4 indicates a little more pain, 6 indicates more pain, 8 indicates a lot of pain, and 10 indicates the worst pain.
FLACC Behavioral Pain Assessment scale
The FLACC scale scores pain intensity by rating five behaviors (face, legs, activity, consolability and crying) to obtain a score out of 10. The FLACC scale is a composite of five behaviours ('face', 'legs', 'activity', 'cry' and 'consolability') considered indicative of pain that can be detected and graded by an observer. Each item is scored on a zero to two scale resulting in a pain intensity score ranging from zero to 10. The original instructions for use recommended observing the child for one to five minutes and matching the observed behaviours to those described in the scale for each item.
Wisconsin Gait Scale (WGS)
The WGS, consisting of four subscales, evaluates 14 gait parameters which can be observed in the affected leg during consecutive gait stages, i.e. stance, toe off, swing and heel strike phases. Additionally, it accounts for the use of hand held gait aid while walking. The first subscale is designed to assess spatiotemporal gait parameters, while kinematic parameters are evaluated by subscale one, two, three and four. In all the items of the scale subjects can score from 1 to 3 points, except for Item One (1-5 points) and Item Eleven (1-4 points). The total number of points falls between 13.35 and 42, a higher score corresponding to greater gait impairments.

Secondary Outcome Measures

Full Information

First Posted
August 19, 2023
Last Updated
August 19, 2023
Sponsor
Muğla Sıtkı Koçman University
search

1. Study Identification

Unique Protocol Identification Number
NCT06009354
Brief Title
Effectiveness of Education in Relaxation Surgeries
Official Title
Effectiveness of Multi-Component Training in Lower Extremity Release Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 22, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 21, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Muğla Sıtkı Koçman University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
The control group will receive the usual post-operative applications (elevation, rest, cold application, stretching).
Intervention Type
Other
Intervention Name(s)
Rehabilitation
Intervention Description
The control group will receive post-operative usual practices. The study group will receive multi-component education in addition to the usual practices.
Primary Outcome Measure Information:
Title
Tampa Scale for Kinesiophobia (TSK)
Description
The questionnaire is a 17-item scale developed to measure fear of movement/reinjury. The normal score range is between 17 and 68.
Time Frame
Change from Baseline TSK at 8 weeks
Title
Pain Catastrophising Scale (PCS)
Description
Scale is used to assess the patient's feelings and thoughts about pain and disaster. The total score ranges from 0 to 52 points. A high score indicates a bad situation.
Time Frame
Change from Baseline PCS at 8 weeks
Title
Timed Up and Go Test (TUG)
Description
Participants sit in a chair with arms, hips and knees bent approximately 90◦ and feet resting on the floor. Lower limb orthoses are worn if used. Participants are asked to stand up, walk 10 steps, walk around a mark on the floor, walk back to the chair and sit down. The timing of the TUG test starts with the standing movement after the "ready, go" signal and ends when the participants are seated in the chair and the movement is finished.
Time Frame
Change from Baseline TUG at 8 weeks
Title
One Leg Standing Test (OLST)
Description
Children are tested standing on one leg using their right and left leg respectively. The test is repeated on a hard surface with eyes open and closed. The child is asked to place both hands on the hips and look at a target on the wall at eye level at a distance of 1 meter. The child is asked to stand with one leg while keeping the other leg in a 90 degree flexion position. A stopwatch is used to record the time the child can hold the test position. The examiner ends the test if the child can hold the position for more than 30 seconds and records the elapsed time.
Time Frame
Change from Baseline OLST at 8 weeks
Title
Functional Reach Test (FRT)
Description
The subject stands sideways next to a wall and flexes the shoulder 90 degrees. The 3rd metacarpal level is marked on the wall. The subject reaches as far as he/she can without taking a step. The 3rd metacarpal line is marked again. The difference between the marks is measured and noted.
Time Frame
Change from Baseline FRT at 8 weeks
Title
Gross Motor Function Classification System (GMFCS)
Description
The aim of this classification system is to provide a standardized classification of motor disability patterns in children with CP. It is a five-level ordinal grading system for classifying gross motor function in a child with CP, with level I representing the least limitation and level V the most limitation. At level I, children show mild involvement and can perform most of the activities of their peers. At level V, children show severe involvement, lacking head control and sitting balance.
Time Frame
Change from Baseline GMFCS at 8 weeks
Title
Modified Ashworth Scale (MAS)
Description
The Modified Ashworth Scale (MAS) is an indirect measure of the nature of spasticity. The MAS is a scale of perceived resistance (tone) to passive movement of the limb and is an adaptation of the original Ashworth Scale with the addition of the 1+ category.
Time Frame
Change from Baseline MAS at 8 weeks
Title
Wong-Baker FACES Pain Rating Scale (WBFPRS)
Description
The Wong-Baker FACES Pain Rating Scale shows six faces with increasing degrees of pain from left to right and each face is rated out of 10. 0 indicates no pain, 2 indicates a little pain, 4 indicates a little more pain, 6 indicates more pain, 8 indicates a lot of pain, and 10 indicates the worst pain.
Time Frame
Change from Baseline WBFPRS at 8 weeks
Title
FLACC Behavioral Pain Assessment scale
Description
The FLACC scale scores pain intensity by rating five behaviors (face, legs, activity, consolability and crying) to obtain a score out of 10. The FLACC scale is a composite of five behaviours ('face', 'legs', 'activity', 'cry' and 'consolability') considered indicative of pain that can be detected and graded by an observer. Each item is scored on a zero to two scale resulting in a pain intensity score ranging from zero to 10. The original instructions for use recommended observing the child for one to five minutes and matching the observed behaviours to those described in the scale for each item.
Time Frame
Change from Baseline FLACC at 8 weeks
Title
Wisconsin Gait Scale (WGS)
Description
The WGS, consisting of four subscales, evaluates 14 gait parameters which can be observed in the affected leg during consecutive gait stages, i.e. stance, toe off, swing and heel strike phases. Additionally, it accounts for the use of hand held gait aid while walking. The first subscale is designed to assess spatiotemporal gait parameters, while kinematic parameters are evaluated by subscale one, two, three and four. In all the items of the scale subjects can score from 1 to 3 points, except for Item One (1-5 points) and Item Eleven (1-4 points). The total number of points falls between 13.35 and 42, a higher score corresponding to greater gait impairments.
Time Frame
Change from Baseline WGS at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fatih Özden, PhD
Phone
543 433 4593
Ext
+90
Email
fatihozden@mu.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmet İmerci, MD
Organizational Affiliation
Muğla Sıtkı Koçman University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Fatih Özden, PhD
Organizational Affiliation
Muğla Sıtkı Koçman University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
İsmet Tümtürk, MSc
Organizational Affiliation
Süleyman Demirel University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
İsmet Uysal, PhD
Organizational Affiliation
Muğla Sıtkı Koçman University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Muğla Sıtkı Koçman Training and Research Hospital
City
Muğla
State/Province
Menteşe
ZIP/Postal Code
48000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmet İmerci, MD
Phone
506 893 5276
Ext
+90
Email
ahmetimerci@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effectiveness of Education in Relaxation Surgeries

We'll reach out to this number within 24 hrs