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

NCT ID: NCT06610370

Last Updated: 2024-09-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 95 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-06-01

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.

Detailed Description

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.

Conditions

Spastic Cerebral Palsy; Walking, Difficulty; Ambulation Difficulty

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Group 1

Intervention Type: 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.

Interventions

Group 1

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Acıbadem Atunizade Hospital

OTHER

Sponsor Role: lead

Responsible Party

Neslihan Yildizdagi

Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Acıbadem Altunizade Hospital

Istanbul, AA, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

NesliYildizdagi

Identifier Type: -

Identifier Source: org_study_id