Clinical trial NCT05577546: The Effect of Conservative Treatment on Gait Biomechanics in Adolescent Idiopathic Scoliosis
Official title: The Effect of Conservative Treatment on Gait Biomechanics in Adolescent Idiopathic Scoliosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Gait Disorder, Sensorimotor
Keywords: adolescent idiopathic scoliosis
gait analysis
gait biomechanics
kinetic
kinematic
Lead sponsor: Medipol University
Sponsor class: OTHER
Collaborators: name: University of Ljubljana
name: Moor Orthotics and Prosthetics
First posted: 2022-10-13
Enrollment: 45
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adolescent idiopathic scoliosis (AIS) is a three-dimensional complex progressive structural deformity of the growing spine. Asymmetric changes in both the anatomical structure and strength of the muscles due to deformity affect weight distribution and joint moments in the trunk and lower extremities. As the spine transfers loads through the pelvis, asymmetry in the spinal alignment creates structural or functional changes involving other parts of the kinetic chain. The deviations caused by the deformity in all three planes and the responses to it affect the kinetics and kinematics of the trunk and extremities. A number of kinetic and kinematic changes such as decreased hip muscle strength, asymmetric lateral stepping, decreased hip and pelvic joint range of motion, especially in the frontal and transverse planes, and ground reaction force asymmetry has been demonstrated in patients with AIS. Understanding the postural changes and correction strategies that affect the displacement of the center of mass, ground reaction force and center of pressure during standing and walking in adolescents with idiopathic scoliosis is fundamental to understanding the nature of the disease, disease management and guiding rehabilitation both conservative treatment and after surgery. Based on this, it was aimed to objectively measure the biomechanical effects of the forces applied to the body in the brace to control deformity and prevent progression during the growth period, to determine postural control strategies, kinetic and kinematic changes in these patients with treatment by applying MOOR-S model brace and Schroth Three-Dimensional Scoliosis Exercise Treatment as a conservative treatment method on patients with AIS. In addition, it was also aimed to determine lower extremity inequality by measuring dynamic leg length with gait analysis in individuals with functional leg length discrepancy due to scoliosis.

Detailed description: Adolescent idiopathic scoliosis (AIS) is a three-dimensional complex progressive structural deformity of the growing spine. Asymmetric changes in both the anatomical structure and strength of the muscles due to deformity affect weight distribution and joint moments in the trunk and lower extremities. As the spine transfers loads through the pelvis, asymmetry in the spinal alignment creates structural or functional changes involving other parts of the kinetic chain. The deviations caused by the deformity in all three planes and the responses to it affects the kinetics and kinematics of the trunk and extremities. Various postural compensatory strategies emerge to maintain a stable position and energy conservation in deviation of the center of mass. Thorax-pelvis coordination plays an important role in maintaining the stability of the whole body in normal walking, the thorax and pelvis counter-rotate towards each other, minimizing the angular momentum of the trunk. In individuals with idiopathic scoliosis, higher in-phase and lower anti-phase coordination in the transverse planes in walking; less coordination consistency were observed in the transverse and frontal planes compared to healthy controls. Most of the studies on gait in AIS have concluded that there is no significant difference in walking speed, cadence and stride width in scoliosis patients and healthy controls. However, decreased hip and pelvic motion, increased energy consumption for gait, step pattern asymmetry, and ground reaction force asymmetry were observed in patients with AIS. A number of kinetic and kinematic changes such as decreased hip muscle strength, asymmetric lateral stepping, decreased hip and pelvic joint range of motion, especially in the frontal and transverse planes, and ground reaction force asymmetry has been demonstrated in patients with AIS. None of the studies included follow-up, most of them did not use EMG, the relationship with curvature types was not clearly revealed, and no treatment effect and follow-up results were evaluated. With this study, the deficiency in the literature will be tried to be overcome, especially in terms of the effect of conservative treatment on gait. Understanding the postural changes and correction strategies that affect the displacement of the center of mass, ground reaction force and center of pressure during standing and walking in adolescents with idiopathic scoliosis is fundamental to understanding the nature of the disease, disease management and guiding rehabilitation both conservative treatment and after surgery. Based on this, it was aimed to objectively measure the biomechanical effects of the forces applied to the body in the brace to control deformity and prevent progression during the growth period, to determine postural control strategies, kinetic and kinematic changes in these patients with treatment by applying MOOR-S model brace and Schroth Three-Dimensional Scoliosis Exercise Treatment as a conservative treatment method on patients with AIS. In addition, it was also aimed to determine lower extremity inequality by measuring dynamic leg length with gait analysis in individuals with functional leg length discrepancy due to scoliosis. Individuals who are diagnosed with AIS and decided to treat a brace, Cobb angle between 20-45 degree and age between 10-18, will be included in the study. Participants will be divided into three groups. The first group will receive MOOR-S brace treatment, the second group will receive the MOOR-S brace and Schroth Three-Dimensional Scoliosis Exercise Treatment, and the third group will not receive any intervention, this group will consist of healthy volunteers from the same age group. Full-time brace treatment will be given to the treatment groups for three months and the second group will be given a home exercise program four days a week and they will perform once a week under physiotherapist supervision. The body center of mass, ground reaction force, range of motion, joint moments and strengths, spinal flexibility, muscle activity in gait, dynamic deviation of the rotational trunk-pelvis segment position, position and orientation of the body segments in three planes, will determine statically and dynamically when they walking, it will be analyzed before and after three months treatment, patients with AIS will be compared with their healthy peers, and the effects of treatment on gait will be determined in the study sample.

Eligibility criteria: Inclusion Criteria:

* Patients, diagnosed with AIS and referred to brace center for conservative treatment by the physician
* Cobb angle between of 20-45°
* ages 10 to 18 years
* no treatment before
* Individuals with family consent will be included

Exclusion Criteria:

* Spine surgery
* A history of major lower extremity trauma and associated surgery
* Leg length inequality more than 1 cm
* Other musculoskeletal pathologies that may affect gait
* Presence of transitional vertebrae
* Scoliosis due to other etiology
* Presence of infection, tumor, rheumatic and neurological disease which affected spine

Primary outcomes:
measure: Body center of mass
timeFrame: Change from baseline body center of mass at 3 months
measure: Center of pressure
timeFrame: Change from baseline center of pressure at 3 months
measure: Thorax-pelvis coordination pattern
timeFrame: Change from baseline thorax-pelvis coordination pattern at 3 months
measure: Dynamic leg length
timeFrame: Change from baseline dynamic leg length at 3 months
measure: Trunk, pelvis and lower extremity kinetics
timeFrame: Change from baseline trunk, pelvis and lower extremity kinetics at 3 months
measure: Trunk, pelvis and lower extremity kinematics
timeFrame: Change from baseline trunk, pelvis and lower extremity kinematics at 3 months
measure: Time-distance parameters of gait
timeFrame: Change from baseline time-distance parameters of gait at 3 months
Secondary outcomes:
measure: The angle of trunk rotation
timeFrame: Change from baseline the angle of trunk rotation at 3 months
measure: Cobb angle
timeFrame: Baseline
measure: Risser stage
timeFrame: Baseline
measure: Deformity classification
timeFrame: Baseline
measure: Generalised joint hypermobility
timeFrame: Baseline
measure: Health Related Quality of life
timeFrame: Change from baseline health related quality of life at 3 months
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University of Ljubljana
Study officials:
affiliation: Medipol University
name: Devrim Tarakcı, Assoc.Prof.
role: STUDY_DIRECTOR
affiliation: University of Ljubljana
name: Janez Vodicar, Assoc.Prof.
role: STUDY_DIRECTOR
affiliation: Medipol University
name: Ahsen Buyukaslan, PhD (c)
role: PRINCIPAL_INVESTIGATOR
References: