The Importance of Physiotherapy After Separation Surgery in Pygopagus Conjoined Twins

September 14, 2024 updated by: Ali Demir, Acıbadem Atunizade Hospital
Motor function delays are observed in pygopagus conjoined twins due to limited movement experience and deficits in proprioceptive sense. This study aimed to evaluate the neuromotor development of conjoined twins who acquired independent bodies, lives, and movements as a result of separation surgery, and to examine the effect of postoperative physiotherapy intervention on gross motor function.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study included two cases of pygopagus conjoined twins who applied for separation surgery at Acıbadem Altunizade Hospital between 2021 and 2022. The twins were 9 months and 21 days old (A1-A2) and 23 months and 11 days old (B1-B2). After separation surgery, a conventional physiotherapy program was administered regularly for 3 months, 6 days a week, with two sessions per day, each lasting 45 minutes. The Bayley-III Developmental Screening Test (DST) was used to evaluate neuromotor development, while the Alberta Infant Motor Scale (AIMS) and the Gross Motor Function Measure-88 (GMFM-88) were used to assess gross motor development. Evaluations were performed preoperatively and at the 3rd postoperative month.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Acıbadem Altunizade Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Having a diagnosis of pygopagus conjoined twins
  • Having normal vital signs after separation surgery

Exclusion Criteria:

  • Having a diagnosis other than pygopagus conjoined twin
  • Abnormal vital signs after separation surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Pygopagus conjoined twins receiving physiotherapy after separation surgery
Physiotherapy was applied to all cases after surgery. The physiotherapy program included neurodevelopmental exercises, balance and proprioception exercises, and stretching exercises.
Other: Physiotherapy
The physical therapy program was applied for 3 months, 6 days a week, 2 sessions per day, and an average session duration of 45 minutes. Each neurodevelopmental exercise and proprioceptive exercise was applied for 10 minutes, and stretching exercises were applied for 45 seconds and 3 repetitions. The exercises included functional rotation, sitting with or without arm support, crawling, kneeling, half kneeling, standing up by holding on, and sequencing exercises. Stretching exercises were mostly positional stretches aimed at lateral flexion of the spine.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Bayley-III Screening Test
Time Frame: 3 months

The Bayley-III is an individually administered scale that assesses the developmental functions of children aged 1-42 months. It evaluates five domains: cognitive, language, motor, social-emotional, and adaptive behavior. The cognitive (91 items), language (97 items), and motor (138 items) domains are assessed using tasks performed with the child, while the social-emotional and adaptive behavior domains are evaluated based on responses to a questionnaire completed by the caregiver.

In the cognitive, language, and motor domains, scoring is done as "completed (1)" or "not completed (0)." The Bayley-III provides various scores for each domain, such as raw scores, scale scores, and composite scores. The scale score, derived from standardizing raw scores by age, is a quick and commonly used method in research.
3 months
Gross Motor Function Measure-88 (GMFM-88)
Time Frame: 3 months

The GMFM-88 consists of 88 items and evaluates the child's performance in five different motor skill areas: A. Lying and Rolling (17 items), B. Sitting (20 items), C. Crawling and Kneeling (14 items), D. Standing (13 items) and E. Walking, Running, and Jumping (24 items). Each item in the GMFM-88 is administered by observing the child's natural movements or by giving instructions.

The items measure the child's ability to perform specific movements. Each movement is scored based on the child's performance, with scores ranging from 0 to 3. 0: Cannot perform the movement, 1: Can partially perform the movement, 2: Can perform the movement independently, 3: Can perform the movement fully and correctly. The scores are summed for each area to obtain a total gross motor function score.
3 months
Alberta Infant Motor Scale (AIMS)
Time Frame: 3 months

The Alberta Infant Motor Scale (AIMS) is an observational assessment used to identify children with delays in motor performance and to provide clinicians and families with information about the child's motor activities. The evaluation of the infant's independent walking and gross motor movements (weight shifting, posture, movements against gravity) takes approximately 20-30 minutes. Movements to be observed are assessed using age-appropriate toys for the infant. During the assessment, the infant continues with spontaneous movements, and postural control is observed while the infant engages in spontaneous motor behaviors.

The AIMS assessment form contains illustrations of the postures and movements that need to be observed in the infant. It includes 58 items: 21 items in the prone position, 9 items in the supine position, 12 items in the sitting position, and 16 items in the standing position. Each item that the infant can perform is scored as "1," and items that cannot be performed
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Acıbadem Atunizade Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gökçen EROL, Acıbadem Atunizade Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ADemir

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be made available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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