The Importance of Physiotherapy After Separation Surgery in Pygopagus Conjoined Twins

NCT06599281 | Not Yet Recruiting

• 1 other identifier: ADemir
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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 effect of postoperative physiotherapy intervention on gross motor function.

Conditions

Pygopagus Conjoined Twins; Separation Surgery; Pediatric Physiotherapy

Keywords

conjoined twins; pygopagus; physiotherapy; gross motor development; neurodevelopment

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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

  3 months

Study Arms (1)

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.

Other: Physiotherapy

Interventions

Physiotherapy OTHER

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.

Pygopagus conjoined twins receiving physiotherapy after separation surgery

Eligibility Criteria

• Age: 0 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Acıbadem Atunizade Hospital: lead

Study Sites (1)

Acıbadem Altunizade Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Twins, Conjoined

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Abnormalities, Severe Teratoid; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Gökçen EROL

  Acıbadem Atunizade Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gökçen EROL

CONTACT

+90 553 464 66 06; fgokcenalaca@gmail.com

Ali DEMİR

CONTACT

+90 553 806 70 51; fzt.alidemir@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Physiotherapist

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: September 15, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)