Cerebral PalsyNCT05957783
Changes in Upper Limb Kinematics in Children With Cerebral Palsy After Lower Limb Surgery
An observational study of Cerebral Palsy and Gait Analysis, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
İntroduction The upper limb can be involved in children with cerebral palsy (CP), while the lower limb is more commonly affected. Little is known regarding the alterations in the upper limb kinematics after the orthopedic surgery of the lower extremity during gait. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Cerebral Palsy, Gait Analysis, Gait Disorders, Neurologic
- What is being tested?
- Cerebral palsy Gait analysis technique
- How many people
- 59 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jan 2021to 13 Apr 2023
- Phase
- Observational
- 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 2 to 17 years
- All sexes
- Child
Study population: children with hemiplegic and diplegic cerebral palsy and 5-15 age health children
Who may be able to join
- children with hemiplegic and diplegic cerebral palsy
- Presence of preoperative and postoperative walking records from the lower extremity in our archive
Who cannot join
- upper extremity surgery
- Video recording does not allow measurement
Trial locations and contacts
1 site in 1 country.
About this study
İntroduction The upper limb can be involved in children with cerebral palsy (CP), while the lower limb is more commonly affected. Little is known regarding the alterations in the upper limb kinematics after the orthopedic surgery of the lower extremity during gait. This study aimed to evaluate the differences in the upper limb kinematics in children with CP between preoperative and postoperative parameters.
Read the detailed description
Metods The study group included 30 children with CP (17 diplegics, 13 hemiplegics; mean age = 12,9 years, range =5-16 years; 18 boys, 12 girls) and the control group consisted of 29 healthy children (15 boys, 14 girls; mean age = 10,2 years, range=5-15 years). Video-based gait analyses of all children were retrospectively evaluated. The follow-up period for the 30 cerebral palsy children included in the study, based on the date of the latest walking video after surgery, was an average of 3.2 ± 1.5 years. The included patients were those who had undergone surgery on the lower extremity (Achilles tendon lengthening, varus derotation osteotomy, periacetabular osteotomy, gastrocnemius release, hamstring release, midfoot osteotomies) without any surgical intervention on the upper extremity and without contracture in the upper extremity. On April 28, 2023, the ethical committee decision 2023/801 was obtained from the Istanbul University Istanbul Medical Faculty Department of Orthopedics and Traumatology.
The inclusion criteria were as follows: diplegic or hemiplegic patients with surgical treatment of the lower extremity, no previous upper extremity surgery, and no contracture in the upper extremity. The exclusion criteria were: incomplete preoperative or postoperative data in the gait analysis records, walking with support or assistance during the gait analysis, and poor video quality that would not allow for measurement. The patients' preoperative and postoperative videos from the gait analysis laboratory and their medical records were retrospectively reviewed. Among the 300 patients who met the inclusion criteria from the 12,567 gait analysis data points, 76 had missing preoperative videos, 87 had missing postoperative videos, 55 were walking with parental assistance, and 52 had video quality that did not allow for measurement.
Coronal and sagittal view videos from the gait analysis were used for evaluation.The preoperative and postoperative videos of the patients were opened on a computer using the AVI or MP4 format and imported into the Kinovea program. The program allowed for slow motion, fast-forward, pause, and angular analysis of the movements in the videos. Using the program, the videos were paused at the initial contact (1), loading response (2), midstance (3), terminal stance (4), pre-swing (5), early swing (6), mid-swing (7), and terminal swing (8) phases in the sagittal plane, and the following angles were measured: the angle between the forearm axis and the third metacarpal axis (wrist sagittal plane angle), the angle between the humerus axis and the forearm axis (elbow sagittal plane angle), the angle between the humerus axis and the vertical line drawn on the ground (shoulder sagittal plane angle), the angle between the line drawn on the sagittal plane of the trunk and the vertical line on the ground (trunk sagittal plane angle), and the angle between the line drawn on the sagittal plane of the head and the vertical line on the ground (head sagittal plane angle). In the coronal plane, the videos were paused at initial contact and midstance, and the following angles were measured: the angle between the humerus axis and the vertical line drawn on the ground (shoulder coronal plane angle), the angle between the line drawn on the axis of the trunk and the vertical line on the ground (trunk coronal plane angle), and the angle between the line drawn on the coronal plane of the head and the vertical line on the ground (head coronal plane angle). In hemiplegic patients, the affected side was considered the patient side, and the unaffected side was considered the healthy side. In the diplegic group, the more affected side was considered the patient side, and the other side was considered the healthy side. If both sides were equally affected, the assignment was randomized between patient and healthy. In the control group, the right upper extremity was assigned as patient side, and the left upper extremity was assigned as healthy.To evaluate the efficacy of the surgery, the Edinburgh score was calculated in patients pre-and postoperatively.
- Being tested
- Cerebral palsy Gait analysis technique
- Medical subject headings
- Cerebral Palsy, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral palsy Gait analysis techniqueOther
Visual gait analysis in cerebral palsy new technique
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Preoperative patient group with diplegic or hemiplegic cerebral palsy Receives: Other: Cerebral palsy Gait analysis technique | |
| Group 2 | Postoperative patient group with diplegic or hemiplegic cerebral palsy Receives: Other: Cerebral palsy Gait analysis technique | |
| Control group | 5-15 age healthy children. Receives: Other: Cerebral palsy Gait analysis technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper extremity angle measure in the all gait phases.
initial contact (1), loading (2), midstance (3), terminal stance (4), pre-swing (5), early swing (6), mid-swing (7), and terminal swing (8) phases in the sagittal plane, and the following angles were measured: wrist sagittal plane angle, elbow sagittal plane angle, shoulder sagittal plane angle, trunk sagittal plane angle and head sagittal plane angle. In the coronal plane, the videos were paused at initial contact and midstance, and the following angles were measured: shoulder coronal plane angle, trunk coronal plane angle and head coronal plane angle.
Measured: 2021-2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start3 Jan 2021
- Primary completion10 Apr 2023
- Study completion13 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasar Samet Gokceoglu, Istanbul University
- Investigators
- Fuat Bilgili, Study director, Istanbul Univercity Istanbul Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957783
- Sponsor's protocol ID
- Cerebralpalsy
- Status last verified
- Jul 2023
- First submitted
- 4 May 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gokceoglu YS, Bilgili F, Sardogan C, Koyuncu D, Demirel M, Akalan E. Changes in upper limb kinematics in children with cerebral palsy after lower limb surgery: a retrospective comparative study. BMC Musculoskelet Disord. 2026 Mar 3;27(1):297. doi: 10.1186/s12891-026-09692-2.
PubMed 41772526
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Upper Limb Kinematics in Children With Cerebral Palsy After Lower Limb Surgery
- ClinicalTrials.gov ID
- NCT05957783
- Acronym / sponsor ID
- Cerebralpalsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 3 Jan 2021 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 13 Apr 2023 (actual)
- First posted
- 24 Jul 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.
İntroduction The upper limb can be involved in children with cerebral palsy (CP), while the lower limb is more commonly affected. Little is known regarding the alterations in the upper limb kinematics after the orthopedic surgery of the lower extremity during gait. This study aimed to evaluate the differences in the upper limb kinematics in children with CP between preoperative and postoperative parameters.
Detailed description
Metods The study group included 30 children with CP (17 diplegics, 13 hemiplegics; mean age = 12,9 years, range =5-16 years; 18 boys, 12 girls) and the control group consisted of 29 healthy children (15 boys, 14 girls; mean age = 10,2 years, range=5-15 years). Video-based gait analyses of all children were retrospectively evaluated. The follow-up period for the 30 cerebral palsy children included in the study, based on the date of the latest walking video after surgery, was an average of 3.2 ± 1.5 years. The included patients were those who had undergone surgery on the lower extremity (Achilles tendon lengthening, varus derotation osteotomy, periacetabular osteotomy, gastrocnemius release, hamstring release, midfoot osteotomies) without any surgical intervention on the upper extremity and without contracture in the upper extremity. On April 28, 2023, the ethical committee decision 2023/801 was obtained from the Istanbul University Istanbul Medical Faculty Department of Orthopedics and Traumatology.
The inclusion criteria were as follows: diplegic or hemiplegic patients with surgical treatment of the lower extremity, no previous upper extremity surgery, and no contracture in the upper extremity. The exclusion criteria were: incomplete preoperative or postoperative data in the gait analysis records, walking with support or assistance during the gait analysis, and poor video quality that would not allow for measurement. The patients' preoperative and postoperative videos from the gait analysis laboratory and their medical records were retrospectively reviewed. Among the 300 patients who met the inclusion criteria from the 12,567 gait analysis data points, 76 had missing preoperative videos, 87 had missing postoperative videos, 55 were walking with parental assistance, and 52 had video quality that did not allow for measurement.
Coronal and sagittal view videos from the gait analysis were used for evaluation.The preoperative and postoperative videos of the patients were opened on a computer using the AVI or MP4 format and imported into the Kinovea program. The program allowed for slow motion, fast-forward, pause, and angular analysis of the movements in the videos. Using the program, the videos were paused at the initial contact (1), loading response (2), midstance (3), terminal stance (4), pre-swing (5), early swing (6), mid-swing (7), and terminal swing (8) phases in the sagittal plane, and the following angles were measured: the angle between the forearm axis and the third metacarpal axis (wrist sagittal plane angle), the angle between the humerus axis and the forearm axis (elbow sagittal plane angle), the angle between the humerus axis and the vertical line drawn on the ground (shoulder sagittal plane angle), the angle between the line drawn on the sagittal plane of the trunk and the vertical line on the ground (trunk sagittal plane angle), and the angle between the line drawn on the sagittal plane of the head and the vertical line on the ground (head sagittal plane angle). In the coronal plane, the videos were paused at initial contact and midstance, and the following angles were measured: the angle between the humerus axis and the vertical line drawn on the ground (shoulder coronal plane angle), the angle between the line drawn on the axis of the trunk and the vertical line on the ground (trunk coronal plane angle), and the angle between the line drawn on the coronal plane of the head and the vertical line on the ground (head coronal plane angle). In hemiplegic patients, the affected side was considered the patient side, and the unaffected side was considered the healthy side. In the diplegic group, the more affected side was considered the patient side, and the other side was considered the healthy side. If both sides were equally affected, the assignment was randomized between patient and healthy. In the control group, the right upper extremity was assigned as patient side, and the left upper extremity was assigned as healthy.To evaluate the efficacy of the surgery, the Edinburgh score was calculated in patients pre-and postoperatively.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Cerebral palsy Gait analysis techniquePreoperative patient group with diplegic or hemiplegic cerebral palsy |
| Group 2 | – | Other: Cerebral palsy Gait analysis techniquePostoperative patient group with diplegic or hemiplegic cerebral palsy |
| Control group | – | Other: Cerebral palsy Gait analysis technique5-15 age healthy children. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- children with hemiplegic and diplegic cerebral palsy and 5-15 age health children
Key inclusion criteria (2 listed)
- children with hemiplegic and diplegic cerebral palsy
- Presence of preoperative and postoperative walking records from the lower extremity in our archive
Key exclusion criteria (2 listed)
- upper extremity surgery
- Video recording does not allow measurement
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 |
|---|---|---|
| Cerebral palsy Gait analysis techniqueVisual gait analysis in cerebral palsy new technique | Other | Control group, Group 1, Group 2 |
Primary outcome
Upper extremity angle measure in the all gait phases.
Time frame: 2021-2023
initial contact (1), loading (2), midstance (3), terminal stance (4), pre-swing (5), early swing (6), mid-swing (7), and terminal swing (8) phases in the sagittal plane, and the following angles were measured: wrist sagittal plane angle, elbow sagittal plane angle, shoulder sagittal plane angle, trunk sagittal plane angle and head sagittal plane angle. In the coronal plane, the videos were paused at initial contact and midstance, and the following angles were measured: shoulder coronal plane angle, trunk coronal plane angle and head coronal plane angle.
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 24 Jul 2023.
- Derived from this study: PubMed 41772526Gokceoglu YS, Bilgili F, Sardogan C, Koyuncu D, Demirel M, Akalan E. Changes in upper limb kinematics in children with cerebral palsy after lower limb surgery: a retrospective comparative study. BMC Musculoskelet Disord. 2026 Mar 3;27(1):297. doi: 10.1186/s12891-026-09692-2.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
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.
Fuat Bilgili study director
Istanbul Univercity Istanbul Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Gait Analysis, run by Istanbul 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 2 inclusion and 2 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 24 Jul 2023. 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?
Upper extremity angle measure in the all gait phases. (time frame: 2021-2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05957783, which also lists 1 linked publication.
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 24 Jul 2023.