Pygopagus Conjoined TwinsNCT06599281
The Importance of Physiotherapy After Separation Surgery in Pygopagus Conjoined Twins
A study testing Physiotherapy in people with Pygopagus Conjoined Twins and Separation Surgery, run by Acıbadem Atunizade Hospital at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Pygopagus Conjoined Twins, Separation Surgery, Pediatric Physiotherapy
- What is being tested?
- Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2024to 31 Dec 2024
- 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 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Having a diagnosis of pygopagus conjoined twins
- Having normal vital signs after separation surgery
Who cannot join
- Having a diagnosis other than pygopagus conjoined twin
- Abnormal vital signs after separation surgery
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Physiotherapy
- Keywords
- conjoined twins, pygopagus, physiotherapy, gross motor development, neurodevelopment
- Medical subject headings
- Twins, Conjoined
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pygopagus conjoined twins receiving physiotherapy after separation surgery | Other | Physiotherapy was applied to all cases after surgery. The physiotherapy program included neurodevelopmental exercises, balance and proprioception exercises, and stretching exercises. Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bayley-III Screening Test
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.
Measured: 3 months
Gross Motor Function Measure-88 (GMFM-88)
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.
Measured: 3 months
Alberta Infant Motor Scale (AIMS)
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Sep 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pygopagus Conjoined TwinsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acıbadem Atunizade Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Demir, Acıbadem Atunizade Hospital
- Investigators
- Gökçen EROL, Principal investigator, Acıbadem Atunizade Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599281
- Sponsor's protocol ID
- ADemir
- Status last verified
- Sep 2024
- First submitted
- 5 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Importance of Physiotherapy After Separation Surgery in Pygopagus Conjoined Twins
- ClinicalTrials.gov ID
- NCT06599281
- Acronym / sponsor ID
- ADemir
- Keywords
- conjoined twins, pygopagus, physiotherapy, gross motor development, neurodevelopment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Acıbadem Atunizade HospitalUniversity, hospital or other
- Study start
- 15 Sep 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 Sep 2024 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pygopagus conjoined twins receiving physiotherapy after separation surgery | Other | Other: PhysiotherapyPhysiotherapy was applied to all cases after surgery. The physiotherapy program included neurodevelopmental exercises, balance and proprioception exercises, and stretching exercises. |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Having a diagnosis of pygopagus conjoined twins
- Having normal vital signs after separation surgery
Key exclusion criteria (2 listed)
- Having a diagnosis other than pygopagus conjoined twin
- Abnormal vital signs after separation surgery
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 |
|---|---|---|
| PhysiotherapyThe 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. | Other | Pygopagus conjoined twins receiving physiotherapy after separation surgery |
Primary outcome
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.
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No. Individual participant data will not be made available to other researchers.
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.
Gökçen EROL principal investigator
Acıbadem Atunizade Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy in people with Pygopagus Conjoined Twins and Separation Surgery, run by Acıbadem Atunizade Hospital 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gökçen EROL (+90 553 464 66 06, fgokcenalaca@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bayley-III Screening Test (time frame: 3 months). The study lists 3 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 19 Sep 2024.