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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Turkey (Türkiye)1 site
  • University

    Istanbul, 34093

Other trials in Turkey (Türkiye)

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 groups in NCT05957783
Study groupRoleWhat they receive
Group 1Preoperative patient group with diplegic or hemiplegic cerebral palsy
Receives: Other: Cerebral palsy Gait analysis technique
Group 2Postoperative patient group with diplegic or hemiplegic cerebral palsy
Receives: Other: Cerebral palsy Gait analysis technique
Control group5-15 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.

  1. 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.

  1. First posted24 Jul 2023
  2. Study start3 Jan 2021
  3. Primary completion10 Apr 2023
  4. Study completion13 Apr 2023

Resources

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)
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

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.

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