Cerebral PalsyNCT06009354
Effectiveness of Education in Relaxation Surgeries
A study testing Rehabilitation in people with Cerebral Palsy, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 May 2023to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Multi-Component Training in Lower Extremity Release Surgery
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
- Being tested
- Rehabilitation
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationOther
The control group will receive post-operative usual practices. The study group will receive multi-component education in addition to the usual practices.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Other: Rehabilitation |
| Control Group | Active comparator | The control group will receive the usual post-operative applications (elevation, rest, cold application, stretching). Receives: Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline TSK at 8 weeks
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.
Measured: Change from Baseline PCS at 8 weeks
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.
Measured: Change from Baseline TUG at 8 weeks
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.
Measured: Change from Baseline OLST at 8 weeks
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.
Measured: Change from Baseline FRT at 8 weeks
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.
Measured: Change from Baseline GMFCS at 8 weeks
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.
Measured: Change from Baseline MAS at 8 weeks
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.
Measured: Change from Baseline WBFPRS at 8 weeks
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.
Measured: Change from Baseline FLACC at 8 weeks
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.
Measured: Change from Baseline WGS at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start22 May 2023
- Primary completion1 Jul 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Ozden, Muğla Sıtkı Koçman University
- Investigators
- Fatih Özden, PhD, Principal investigator, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009354
- Sponsor's protocol ID
- CP gevşetme
- Status last verified
- Dec 2025
- First submitted
- 19 Aug 2023
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Multi-Component Training in Lower Extremity Release Surgery
- ClinicalTrials.gov ID
- NCT06009354
- Acronym / sponsor ID
- CP gevşetme
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 22 May 2023 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 24 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: RehabilitationThe 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. |
| Control Group | Active comparator | Other: RehabilitationThe control group will receive the usual post-operative applications (elevation, rest, cold application, stretching). |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RehabilitationThe control group will receive post-operative usual practices. The study group will receive multi-component education in addition to the usual practices. | Other | Control Group, Intervention Group |
Primary outcome
Tampa Scale for Kinesiophobia (TSK)
Time frame: Change from Baseline TSK at 8 weeks
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)
Time frame: Change from Baseline PCS at 8 weeks
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)
Time frame: Change from Baseline TUG at 8 weeks
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)
Time frame: Change from Baseline OLST at 8 weeks
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)
Time frame: Change from Baseline FRT at 8 weeks
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)
Time frame: Change from Baseline GMFCS at 8 weeks
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)
Time frame: Change from Baseline MAS at 8 weeks
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)
Time frame: Change from Baseline WBFPRS at 8 weeks
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
Time frame: Change from Baseline FLACC at 8 weeks
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)
Time frame: Change from Baseline WGS at 8 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatih Özden, PhD principal investigator
Muğla Sıtkı Koçman University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation in people with Cerebral Palsy, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tampa Scale for Kinesiophobia (TSK) (time frame: Change from Baseline TSK at 8 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.