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

NCT06610370 | Completed

• 1 other identifier: NesliYildizdagi
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spastic Cerebral Palsy; Walking, Difficulty; Ambulation Difficulty

Keywords

cerebral palsy; ambulation; selective dorsal rhizotomy; gross motor function

Outcome Measures

Primary Outcomes (2)

• Gross Motor Function Measure-88 (GMFM-88)

  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.

  baseline

• Gross Motor Function Classification System (GMFCS)

  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.

  baseline

Study Arms (1)

Children with Spastic Cerebral Palsy

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.

Other: Group 1

Interventions

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.

Children with Spastic Cerebral Palsy

Eligibility Criteria

• Age: 1 Day - 17 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

95 children with spastic cerebral palsy were included in the study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Acıbadem Atunizade Hospital: lead

Study Sites (1)

Acıbadem Altunizade Hospital

Istanbul, AA, 34662, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy; Mobility Limitation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 24, 2024
• Study Start: September 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)