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Completed

NCT Number: NCT06610370

Predicting Postoperative Ambulation Following Selective Dorsal Rhizotomy Based on Preoperative Gross Motor Function Score

Cerebral Palsy (CP) is a neurodevelopmental disorder characterized by abnormalities in muscle tone, movement, and motor skills resulting from permanent, nonprogressive damage to the developing brain before, during, or after birth (Tedla & Reddy, 2021). The worldwide prevalence of CP is 2-3 per 1000 live births (Paul et al., 2022). The most common type of CP is spastic, accounting for approximately 85% of all CP cases (Paul et al., 2022). It is divided into 3 types: hemiparetic, diparetic, and quadriparetic. Selective Dorsal Rhizotomy (SDR) is a surgical technique applied for spasticity management in children with bilateral spastic type CP (Novak et al., 2014). One of the most important points in the decision-making process for SDR surgery is the compatibility of the family's expectations with the expectations of the healthcare professional. Informing the family about the expectations is very important in the decision-making process for surgery (Waite et al., 2023). No study has been found in the literature that provides objective predictive value before surgery in terms of postoperative ambulation. The aim of this study is to examine the predictability of postoperative ambulation status in patients with Spastic Cerebral Palsy (SCP) according to the Gross Motor Function Measure-88 (GMFM-88) score before SDR.

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Key information

Age range

1 day–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Acıbadem Altunizade Hospital

Istanbul, AA, 34662, Turkey (Türkiye)

About this study

It is an observational study. Purpose of the study: The aim of this study was to examine the predictability of postoperative ambulation status in patients with spastic Cerebral Palsy (SCP) according to the Gross Motor Function Measure-88 (GMFM-88) score before SDR.

95 children with CP were included in the study. Among SCP cases, 71(74.7%) were diparetic, 18(18.9%) were quadriparetic, and 6 (6.3%) were triplegia.

  • Can the total score of a gross motor function measure before SDR predict walking after SDR?
  • Can the gross motor function measure total score before SDR surgery provide an indication of the family's postoperative walking expectations?

The Gross Motor Function Measure-88 (GMFM-88) and the Gross Motor Function Classification System (GMFCS) were applied to the participants.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 0-17,
  • Diagnosis of spastic CP,
  • Participants and parents willing to participate in the study voluntarily,
  • Gross Motor Function Classification System (GMFCS) level between II-IV,
  • No history of orthopedic surgery before SDR surgery,
  • Actively continuing the Physiotherapy and Rehabilitation (PTR) program for at least 2 months in the post-operative period.

Exclusion criteria

  • Having different types of CP such as dyskinetic, ataxic and mixed type
  • Having hemiparetic type CP
  • Having a history of any surgery on the musculoskeletal system before SDR surgery
  • Having received Botulinum Toxin injection within the last 6 months.

Treatment and study plan

Group 1

Other

95 children with spastic cerebral palsy were included. Gross Motor Function Measure-88 (GMFM-88) and Gross Motor Function Classification System (GMFCS) were applied to the cases before and after the Selective Dorsal Rhizotomy (SDR) surgery.

Primary outcomes

  1. Gross Motor Function Measure-88 (GMFM-88)

    Time frame: baseline

    It is an observational scale developed to evaluate gross motor skills and determine limitations in children with CP. Gross motor function is evaluated in 5 sections: supine-prone position and turning, sitting, crawling and kneeling, standing and walking-running and jumping. It consists of a total of 88 items. Each item is scored as 0, 1, 2, 3 or "not tested" and the total score and percentage (%) are calculated.

  2. Gross Motor Function Classification System (GMFCS)

    Time frame: baseline

    It is used to classify motor disorders in children with CP and to describe the severity and course of the disease. The functional status of children with CP is defined in 5 levels. The main difference between the levels is that there is a place for daily living activities. Level I; describes walking without restrictions; level V: describes being carried in a manually propelled wheelchair. The main difference between the levels is that daily life activities also have a place. Every level has its own definition for a variety of ages. The evaluation was made according to the definitions given according to the age of each child.

Sponsors and collaborators

Lead sponsor

Acıbadem Atunizade Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 24, 2024
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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