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

NCT05577546 | Active Not Recruiting

• 1 other identifier: MUET2020-798
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent Idiopathic Scoliosis; Gait Disorder, Sensorimotor

Keywords

adolescent idiopathic scoliosis; gait analysis; gait biomechanics; kinetic; kinematic

Outcome Measures

Primary Outcomes (7)

• Body center of mass

  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.

  Change from baseline body center of mass at 3 months

• Center of pressure

  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.

  Change from baseline center of pressure at 3 months

• Thorax-pelvis coordination pattern

  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.

  Change from baseline thorax-pelvis coordination pattern at 3 months

• Dynamic leg length

  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.

  Change from baseline dynamic leg length at 3 months

• Trunk, pelvis and lower extremity kinetics

  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

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

• Trunk, pelvis and lower extremity kinematics

  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.

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

• Time-distance parameters of gait

  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.

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

Secondary Outcomes (6)

• The angle of trunk rotation

  Change from baseline the angle of trunk rotation at 3 months

• Cobb angle

  Baseline

• Risser stage

  Baseline

• Deformity classification

  Baseline

• Generalised joint hypermobility

  Baseline

Study Arms (3)

Brace group

EXPERIMENTAL

Fifteen patients with AIS will be included in this group. The scoliosis brace, whose characteristics are described below under the "Brace" heading, will be worn by the patient for 12 weeks. Although the daily brace wearing time varies between 20-23 hours, depending on the patient, it will be determined according to the physician's recommendation. Compliance regarding the brace will be monitored from the parent-controlled charts where the daily wearing time is recorded by the patient

Other: Moor S brace treatment

Brace and Schroth exercise group

EXPERIMENTAL

Fifteen patients with AIS will be included in this group, they will be treated by brace and exercise during 12 weeks. The same brace treatment protocol as the brace group will be applied for this group. Additionally, Schroth Three-Dimensional Scoliosis Exercise Treatment will be applied to this group by the researcher physiotherapist at the brace center. Exercise therapy will be carried out at the brace center once a week with the researcher physiotherapist, and 45 min a day, 4 days a week in the form of home exercises. The number of exercise sets and repetitions will be determined by the researcher physiotherapist according to the patient, considering deformity severity and flexibility, generalized joint hypermobility, bone maturation, menarche status and the risk of progression. Compliance with the home exercise program (frequency and duration) will be recorded by the patients in a home exercise diary for 12 weeks.

Other: Moor S brace treatment; Other: Schroth Three-Dimensional Scoliosis Exercise Treatment

Healthy control group

NO INTERVENTION

Fifteen healthy volunteers between the ages of 10-18 will be included in this group. No intervention will be applied to this group and they will only be assessed, and their findings obtained from the gait analysis will compare with the patient groups.

Interventions

Moor S brace treatment OTHER

The rigid MOOR-S Brace controls the thoracic, lumbar and pelvis blocks very tightly, is modelled and produced according to deformity type and patients body size considering the standardization of the MOOR-S Model. It is a CAD-CAM design-based rigid torocolumbosacral orthosis, using polypropylene material, which is opened from the front, and tightness can be adjusted by the patients with the help of straps. Additional corrective forces can be applied with pads that can be added to the brace. The amount of corrective forces in the MOOR-S brace is decided by the experienced orthotist, taking into account risk of progression, the flexibility of the spine deformity, Cobb angle, bone maturation and age. An external stimulus is provided that directs the protracted shoulder to slightly to the posterior by the shoulder part, located on the anterosuperior side of the brace.

Brace and Schroth exercise group; Brace group

Schroth Three-Dimensional Scoliosis Exercise Treatment OTHER

Schroth Three-Dimensional Scoliosis Exercise Treatment has the main features of physiotherapeutic scoliosis-specific exercises: 1) Three-dimensional self-correction, 2) Training activities of daily living (ADL), and 3) Stabilization of the corrected posture. The basic principles of the Schroth method are autoelongation, deflection, derotation, rotational angular breathing and stabilization. Exercise therapy will be carried out at the brace center once a week with the researcher, and 45 min a day, 4 days a week in the form of home exercises. The number of exercise sets and repetitions will be determined by the physiotherapist according to the patient, considering deformity severity and flexibility, generalized joint hypermobility, bone maturation, menarche status and the risk of progression. Compliance with the home exercise program (frequency and duration) will be recorded by the patients in a home exercise diary for 12 weeks.

Also known as: Schroth Therapy

Brace and Schroth exercise group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medipol University: lead
• University of Ljubljana: collaborator
• Moor Orthotics and Prosthetics: collaborator

Study Sites (1)

University of Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Devrim Tarakcı, Assoc.Prof.

  Medipol University

  STUDY DIRECTOR

• Janez Vodicar, Assoc.Prof.

  University of Ljubljana

  STUDY DIRECTOR

• Ahsen Buyukaslan, PhD (c)

  Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ahsen Buyukaslan, PT, PhD(c)

Study Record Dates

• First Submitted: October 8, 2022
• First Posted: October 13, 2022
• Study Start: April 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

SL (1)