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

NCT ID: NCT05577546

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2025-12-31

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.

Conditions

Adolescent Idiopathic Scoliosis; Gait Disorder, Sensorimotor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Brace group

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

Group Type: EXPERIMENTAL

Moor S brace treatment

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Moor S brace treatment

Intervention Type: 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.

Schroth Three-Dimensional Scoliosis Exercise Treatment

Intervention Type: 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.

Healthy control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Moor S brace treatment

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.

Intervention Type: OTHER

Schroth Three-Dimensional Scoliosis Exercise Treatment

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.

Intervention Type: OTHER

Other Intervention Names

Schroth Therapy

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Ljubljana

OTHER

Sponsor Role: collaborator

Moor Orthotics and Prosthetics

UNKNOWN

Sponsor Role: collaborator

Medipol University

OTHER

Sponsor Role: lead

Responsible Party

Ahsen Büyükaslan

Ahsen Buyukaslan, PT, PhD(c)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Devrim Tarakcı, Assoc.Prof.

Role: STUDY_DIRECTOR

Medipol University

Janez Vodicar, Assoc.Prof.

Role: STUDY_DIRECTOR

University of Ljubljana

Ahsen Buyukaslan, PhD (c)

Role: PRINCIPAL_INVESTIGATOR

Medipol University

Locations

University of Ljubljana

Ljubljana, , Slovenia

Countries

Slovenia

Other Identifiers

MUET2020-798

Identifier Type: -

Identifier Source: org_study_id