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Clinical Trials/NCT05577546
NCT05577546
Active, not recruiting
Not Applicable

The Effect of Conservative Treatment on Gait Biomechanics in Adolescent Idiopathic Scoliosis

Medipol University1 site in 1 country45 target enrollmentApril 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adolescent Idiopathic Scoliosis
Sponsor
Medipol University
Enrollment
45
Locations
1
Primary Endpoint
Dynamic leg length
Status
Active, not recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2022
End Date
December 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Medipol University
Responsible Party
Principal Investigator
Principal Investigator

Ahsen Büyükaslan

Ahsen Buyukaslan, PT, PhD(c)

Medipol University

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

Outcomes

Primary Outcomes

Dynamic leg length

Time Frame: Change from baseline dynamic leg length at 3 months

Dynamic leg length is the effective length of the lower limb, measured by the distance from the hip joint center to the heel, ankle joint center and forefoot, in order to determine possible functional LLD. Measuring dynamic leg length during the gait cycle takes into account the bony segmental length (foot segment, shank segment, thigh segment) and kinematic angles of the lower extremity in the sagittal, frontal and horizontal plane. Dynamic leg length will assess with computerized 3D gait analysis: With the optoelectronic motion capture system by Qualisys Motion Capture System (Gothenburg, Sweden), assessments will be made with bare feet while standing and walking. The system integrated with wireless EMG and force platforms (AMTI) has 12 high-resolution cameras and allows the sensing of movement in three planes by Gait Module for Qualisys Track Manager software with the help of marker placed on specific anatomical reference points in the body.

Body center of mass

Time Frame: Change from baseline body center of mass at 3 months

Body center of mass and its displacement with the brace will assess with computerized 3D gait analysis: With the optoelectronic motion capture system by Qualisys Motion Capture System (Gothenburg, Sweden), assessments will be made with the bare feet while standing and walking. Walking speed is chosen by each individual. Six walking trials will be recorded for each individual on a 15-meter walking path. The system integrated with wireless EMG (Wireless EMG system Delsys) and force platforms (AMTI) has 12 high-resolution cameras and allows the sensing of movement in three planes by Gait Module for Qualisys Track Manager software with the help of marker placed on specific anatomical reference points in the body. Instituti Orthopedici Rizzoli (IOR) Full Body marker protocol was chosen to specify anatomical landmarks.

Thorax-pelvis coordination pattern

Time Frame: Change from baseline thorax-pelvis coordination pattern at 3 months

The dynamic deviation of the rotational thorax-pelvis segment position relative to the progression line will be measured. Thorax-pelvis coordination will reveal the relative rotational range of motion between the head, pelvis and upper body in the coordinate system with the information obtained from the relevant anatomical reference points as in the literature. Thorax-pelvis coordination pattern will assess with computerized 3D gait analysis: With the optoelectronic motion capture system by Qualisys Motion Capture System, assessments will be made with bare feet while standing and walking. The system integrated with wireless EMG and force platforms (AMTI) has 12 high-resolution cameras and allows the sensing of movement in three planes by Gait Module for Qualisys Track Manager software with the help of markers placed on specific anatomical reference points in the body.

Center of pressure

Time Frame: Change from baseline center of pressure at 3 months

The Center of pressure and its displacement with the brace will assess with computerized 3D gait analysis: With the optoelectronic motion capture system by Qualisys Motion Capture System (Gothenburg, Sweden), assessments will be made with the bare feet while standing and walking. Walking speed is chosen by each individual. Six walking trials will be recorded for each individual on a 15-meter walking path. The system integrated with wireless EMG (Wireless EMG system Delsys) and force platforms (AMTI) has 12 high-resolution cameras and allows the sensing of movement in three planes by Gait Module for Qualisys Track Manager software with the help of marker placed on specific anatomical reference points in the body. Instituti Orthopedici Rizzoli (IOR) Full Body marker protocol was chosen to specify anatomical landmarks. Markers will be placed bilaterally at points on the extremity and both sides of the body.

Trunk, pelvis and lower extremity kinetics

Time Frame: Change from baseline trunk, pelvis and lower extremity kinetics at 3 months

Using anthropometric measurements, kinematic data and ground reaction force data, joints moments and forces will be calculated with the "inverse dynamics" method. Body kinetics (kinetic analysis) includes: 1. Ground reaction force: It will be measured in three planes as mediolateral, vertical and anteroposterior with the force platform of the system. 2. Net moment (Nm/kg): The signals received from the muscles will be recorded by superficial EMG. As a result of the internal moment and external moment, the net moment and the flexor and extensor moment related to the dominant muscle group will be revealed. 3. Power: The data obtained from the negative and positive mechanical power graphs will be examined concentric or eccentric contraction and power generation or absorption of the muscles. Body kinetics (kinetic analysis) will assess with computerized 3D gait analysis: With the optoelectronic motion capture system by Qualisys Motion Capture System

Trunk, pelvis and lower extremity kinematics

Time Frame: Change from baseline trunk, pelvis and lower extremity kinematics at 3 months

Body kinematics (kinematic analysis): The position and orientation of the relevant body segments will be measured according to the global coordinate system using the information from the markers and anthropometric data. Through kinematic analysis, joint angles of the head, trunk and extremities in three planes in different phases of gait will be measured. Body kinematics will assess with computerized 3D gait analysis: With the optoelectronic motion capture system by Qualisys Motion Capture System (Gothenburg, Sweden), assessments will be made with bare feet while standing and walking. The system integrated with wireless EMG (Wireless EMG system Delsys) and force platforms (AMTI) has 12 high-resolution cameras and allows the sensing of movement in three planes by Gait Module for Qualisys Track Manager software with the help of marker placed on specific anatomical reference points in the body.

Time-distance parameters of gait

Time Frame: Change from baseline time-distance parameters of gait at 3 months

Time-distance parameters will be measured with the data obtained from the kinematic data and force platforms. 1. Walking speed 2. Cadence 3. Single and double stride length 4. Stance and swing time 5. Single and double support time 6. Walk-Ratio Time-distance parameters will assess with computerized 3D gait analysis: With the optoelectronic motion capture system by Qualisys Motion Capture System (Gothenburg, Sweden), assessments will be made with bare feet while standing and walking. Walking speed is chosen by each individual. Six walking trials will be recorded for each individual on a 15-meter walking path. The system integrated with wireless EMG (Wireless EMG system Delsys) and force platforms (AMTI) has 12 high-resolution cameras and allows the sensing of movement in three planes by Gait Module for Qualisys Track Manager software with the help of marker placed on specific anatomical reference points in the body.

Secondary Outcomes

  • Deformity classification(Baseline)
  • Risser stage(Baseline)
  • Health Related Quality of life(Change from baseline health related quality of life at 3 months)
  • The angle of trunk rotation(Change from baseline the angle of trunk rotation at 3 months)
  • Cobb angle(Baseline)
  • Generalised joint hypermobility(Baseline)

Study Sites (1)

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