Clinical trial NCT06610370: Predicting Postoperative Ambulation Following Selective Dorsal Rhizotomy Based on Preoperative Gross Motor Function Score
Official title: Predicting Postoperative Ambulation Following Selective Dorsal Rhizotomy Based on Preoperative Gross Motor Function Score
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spastic Cerebral Palsy
Walking, Difficulty
Ambulation Difficulty
Keywords: cerebral palsy
ambulation
selective dorsal rhizotomy
gross motor function
Lead sponsor: Acıbadem Atunizade Hospital
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 95
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 95 children with spastic cerebral palsy were included in the study.

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.

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.

Primary outcomes:
measure: Gross Motor Function Measure-88 (GMFM-88)
timeFrame: baseline
measure: Gross Motor Function Classification System (GMFCS)
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Acıbadem Altunizade Hospital
state: AA
Study officials:
References: