NCT06617507

Brief Summary

Cerebral Palsy (CP) is a motor disorder that develops during fetal brain development or due to non-progressive damage to the developing infant brain. These movement and posture disorders are classified as Spastic Type, Dyskinetic Type, Ataxic Type and Mixed Type (Rosenbaum, 2007). Spastic type CP accounts for 20% of all CP cases. Spastic type CP is divided into three groups: diparetic (38%), hemiparetic (39%) and quadriparetic (23%) (Novak et al., 2014). Lower extremity involvement is more common in diparetic cerebral palsy (DCP) (Donker et al., 2008). 98% of DCP cases vary between GMFS levels I and III. Walking rates are between 86-91% (Novak et al., 2014). Children with DCP can usually walk until the age of 4 (Cottalorda, 1998). However, these walks are often; Due to spasticity, muscle weakness, involuntary co-contraction, deficiencies in selective motor control, balance problems, structural changes of soft tissue and compensatory mechanisms (Manca, 2014), it can lead to musculoskeletal system problems and gait pathologies. Although the cerebral lesion that causes is static, children with spastic diplegia increase in height with age, and they may lose their ability to walk because bone length cannot be accompanied by muscle length at the same rate (Miller, 2020). Selective Dorsal Rhizotomy (SDR) surgery is an effective method for spasticity management in children with spastic DCP (Novak et al., 2014). The positive effect of SDR on function and mobility has been proven (Novak et al., 2020). It has been stated that SDR surgery applied to carefully selected candidates may be beneficial on gait quality in individuals with ambulatory CP (Chen, 2019). SDR surgery has been found to improve walking as a result of information collected from patients through a survey (Park, 2021). The aim of our study is to reveal the effect of SDR surgery performed in Turkey on gait function in children with CP using evaluation scales.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2024

Completed
Last Updated

September 27, 2024

Status Verified

September 1, 2024

Enrollment Period

1 month

First QC Date

September 25, 2024

Last Update Submit

September 25, 2024

Conditions

Keywords

Cerebral PalsyGaitSelective Dorsal RhizotomyAmbulation

Outcome Measures

Primary Outcomes (3)

  • The Modified Ashworth Scale (MAS)

    It is a 6-point scale used to describe the muscle's resistance to passive movement and the ease with which the joint can be moved within the available range. It is frequently used in clinical settings. Its evaluation and interpretation are quite practical. Within the scope of the study, lower extremity muscles were evaluated with MAS.

    baseline

  • The Gillette Functional Assessment Questionnaire (FAQ)

    It is a measurement tool used to evaluate walking ability and functional mobility in children. This questionnaire was developed specifically to evaluate the walking functions of children with CP and other neuromuscular disorders. Developed at Gillette Children's Hospital, this survey aims to rate children's walking abilities in different environments. Scores children's walking skills between 1-10.

    baseline

  • The Edinburgh Visual Gait Score (EVGS)

    EVGS is a valid and reliable gait analysis method used in gait evaluation in children with CP. It is a practically used gait analysis that supports observational gait analysis, especially in children with CP with mild involvement and distal deformities. In EVGS, evaluation is made by video recording method. It consists of 17 parameters and evaluates gait in frontal, sagittal and transverse planes. In each lower extremity, 6 anatomical regions, namely trunk, pelvis, hip, knee, ankle and foot, are evaluated separately during the stance and swing phases of gait.

    baseline

Study Arms (1)

Children with diparetic cerebral palsy

20 ambulatory diparetic CP cases were included. The Modified Ashworth Scale (MAS), The Gillette Functional Assessment Questionnaire (FAQ) and The Edinburgh Visual Gait Score (EVGS) were applied to the participants.

Other: Group 1

Interventions

Group 1OTHER

The Modified Ashworth Scale (MAS), The Gillette Functional Assessment Questionnaire (FAQ) and The Edinburgh Visual Gait Score (EVGS) were applied to the participants.

Children with diparetic cerebral palsy

Eligibility Criteria

Age0 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

A total of 20 ambulatory diparetic CP cases, aged between 0-17, who were deemed suitable for SDR surgery and operated on, were included in the study.

You may qualify if:

  • Being between the ages of 0-17
  • Being diagnosed with Diparetic CP, one of the types of Cerebral Palsy

You may not qualify if:

  • Having any history of orthopedic surgery on the musculoskeletal system
  • Having Botulinum Toxin injection in the last 6 months
  • Using of Baclofen Pump

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acıbadem Altunizade Hospital

Istanbul, Altunizade, 34662, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral PalsyGait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gizem Gürzoğlu

    Acıbadem Atunizade Hospital

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 25, 2024

First Posted

September 27, 2024

Study Start

May 1, 2024

Primary Completion

June 1, 2024

Study Completion

September 1, 2024

Last Updated

September 27, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be made available to other researchers.

Locations