Comparison of the Efficiency of Schroth Method and Virtual Reality Exercises in Individuals With AIS

NCT06416579 | Recruiting

• 1 other identifier: IUC4
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Adolescent idiopathic scoliosis (AIS) is a three-dimensional deformity of the spine of unknown etiology, in the treatment of which physiotherapy-specific scoliosis-specific exercise (PSSE), corset and surgical treatment approaches are used depending on the severity of the curvature \[8, 9\]. The Schroth method, one of the PSSE methods, has been shown to reduce the severity of the curvature, Cobb angles and the need for surgery, especially in curvatures between 10-30 degrees, slow down the progression of the curvature, increase back muscle strength and improve respiratory functions \[10-12\]. In the Schroth method, mental imagery, exteroceptive, proprioceptive stimulations and mirror control, which follow motor learning principles and include internal focus, are used to increase body awareness and facilitate the individual's self-posture corrections with postural, sensorimotor and rotational breathing exercises specific to scoliosis \[5, 10\]. In cases that require long-term treatment, such as scoliosis, the motivation and participation of the child and adolescent population in particular decreases and negatively affects the success of treatment \[1, 2\]. Additionally, it has been reported in the literature that patients have difficulty in performing Schroth exercises at home and adapting the corrected posture to daily life\[5\]. For this reason, in order to maintain the corrected posture and make it permanent, motor learning-based approaches must be used \[6\]. Virtual reality rehabilitation (VR) creates an external focus on the individual, allows for a large number of repetitions, and thus encourages motor learning. It is also known that VR increases motivation, participation and exercise performance in children and adolescents\[7\]. When the literature was examined, no studies were found regarding VR in individuals with AIS. The study will show that Schroth-based VR will be effective on spinal parameters, trunk rotation and spinal mobility parameters in cases with AIS. Our aim is to examine the effects of Schroth-based VR in comparison with Schroth exercises in cases with AIS.

Conditions

Scoliosis; Adolescence; Scoliosis; Scoliosis Lumbar Region; Adolescent Idiopathic Scoliosis

Keywords

Scoliosis; exercise; rehabilitation; Adolescent; exercise therapy; Physical Therapy Modalities

Outcome Measures

Primary Outcomes (4)

• Spinal Parameters

  The most commonly used method to measure the size of the scoliosis curve is the Cobb angle. As a standard, measurement is made on a posteroanterior spine radiograph taken while standing. To determine the boundaries of scoliosis, a line is drawn parallel to the upper line of the vertebra with the greatest deviation. Similarly, for the lower border, a line is drawn parallel to the lowest vertebra. Vertical lines parallel to these two lines are drawn and the angle between the two lines is recorded. In our study, the Cobb angle will be measured and recorded in the sagittal and frental planes, based on the same vertebral endplates, on the spine x-ray taken at the beginning and after 24 weeks of treatment by the orthopedic and traumatology physician during the routine follow-up of the patient.

  Baseline and 24th week

• Risser Sign Evaluation

  Risser sign is defined as the change of the pelvic growth plate from cartilage to bone. Gradual ossification of the growth plate on the iliac apophysis from anterolateral to posteromedial is evaluated. Evaluations will be determined by the orthopedic and traumatology physician during routine follow-ups of the patient based on x-rays.

  Baseline and 24th week

• Angle of Trunk Rotation Measurement

  Trunk rotation angle will be measured with a Bunnell scoliometer. There is a metal sphere inside the scoliometer that moves between 0-30˚ in the water bed. Measurements will be made by placing the scoliometer vertically on the axial axis of the spine, perpendicular to the spinosus processes of the vertebra. The evaluation will be carried out standing, in a forward bending position with hands extended forward. To adjust the distance between the feet, the physiotherapist places one foot between the patient's two feet and the patient is positioned. By moving the scoliometer from the beginning of the thoracic region to the sacrum, the largest rotation angle in the major curvature will be recorded. In our study, trunk rotation angle will be measured and recorded at baseline, at week 12, and after 24 weeks of treatment.

  Baseline, 12th week and 24th week

• Spinal Mobility Evaluation

  Evaluation of spinal mobility was performed with a portable, computer-aided electromechanical device (the Spinal Mouse System, Idiag, Fehraltorf, Switzerland) called "Spinal Mouse" (SM). The SM is an external, non-invasive measurement device that can evaluate spinal angles and curvatures in the frontal and sagittal planes. It has been reported that SM can be used as a reliable, fast and easy-to-use measurement method with no side effects for clinical research and patient follow-up in AIS. Measurements were made between the spinous process of the 7th cervical vertebra and the top of the anal fold (approximately the level of the sacral 3rd vertebra). Maximum right-left lateral flexion degrees in the frontal plane and maximum flexion-extension degrees in the sagittal plane will be measured and recorded.

  Baseline, 12th week and 24th week

Secondary Outcomes (8)

• Spinal proprioception assessment:

  Baseline, 12th week and 24th week

• Trunk Isometric Muscle Strength

  Baseline, 12th week and 24th week

• Trunk Muscle Endurance

  Baseline, 12th week and 24th week

• Posterior Trunk Symmetry Index (POTSI)

  Baseline, 12th week and 24th week

• Anterior Trunk Symmetry Index (ATSI)

  Baseline, 12th week and 24th week

Study Arms (3)

Group I-Schroth Exercise Group

EXPERIMENTAL

Participants will be given individually structured scoliosis-specific three-dimensional exercises according to the Schroth method, 2 days a week for 12 weeks, 1 day a week for the next 12 weeks, under the supervision of a physiotherapist, for a total of 36 sessions. Participants will be given a home exercise program to do on the days they do not come to the session, and will be asked whether they have done it or not when they come to each session. The exercise program will be divided into 4 phases: 0-4, 5-8, 9-12, 12-24. Progress in the exercises will be made positionally by increasing the number of repetitions and the number of rotational breathing during the exercise.

Other: Schroth Exercise Group

Group II-Schroth Method Based Virtual Reality Group

EXPERIMENTAL

Participants will undergo a Schroth method-based virtual reality exercise program under the supervision of a physiotherapist, 2 days a week for 12 weeks, and 1 day a week for the next 12 weeks, for a total of 36 sessions. Participants will be given a home exercise program to do on the days they do not come to the session, and will be asked whether they have done it or not when they come to each session. Schroth method based virtual reality exercise program will be made on Nintendo Wii. Games within Nintendo Wii will be implemented in individually configured positions in accordance with the Schroth method.The virtual reality exercise program will be divided into 4 phases: 0-4, 5-8, 9-12, 12-24. Sessions will last 40 minutes in total, including 5 minutes of warm-up, 30 minutes of balance and sports games, and 5 minutes of cool-down. Progression will be made by difficulty level and positional in all games.

Other: Schroth Method Based Virtual Reality Group

Group III-Control Group

OTHER

Participants in the control group will be placed on a waiting list for 24 weeks. Participants will be given initial, intermediate and final evaluations. Participants will not receive any exercise intervention for 24 weeks and will be able to continue their routine physical activities.

Other: Control Group

Interventions

Schroth Exercise Group OTHER

Exercises will be given in lying, sitting and standing positions. In each exercise, elongation of the spine will be ensured and the person will be positioned according to the type of scoliosis. Exercises will be given progressively in supine, prone, side sitting, sitting and standing positions. In each exercise, elongation of the spine will be ensured and the person will be positioned according to the upper and lower extremities. The exercise program will be divided into 4 phases: 0-4, 5-8, 9-12, 12-24. Progress in the exercises will be made positionally by increasing the number of repetitions and the number of rotational breathing during the exercise.

Group I-Schroth Exercise Group

Schroth Method Based Virtual Reality Group OTHER

During Schroth method-based virtual reality exercises, continuity in stabilization will be ensured by using external focus and muscular activation in positions appropriate to the Schroth method and in corrected posture. Sessions will last 40 minutes in total, including 5 minutes of warm-up, 30 minutes of balance and sports games, and 5 minutes of cool-down. Warm-up and cool-down will consist of aerobic games available in Nitendo wii. Balance games will consist of Penguin Slide, Soccer Heading, Table Tilt, Balance Bubble, Ski Slalom, Ski Jump, Tilt City and Snowboard Slalom. Among the sports games, Bowling, Boxing, Tennis and Baseball will be included in the program. Progression will be made by difficulty level and positional in all games. The exercises will be made more difficult by side sitting, side sitting on a stool, sitting position, knight position, standing, sitting on a balance ball, standing on a soft floor, on a bosu ball and moving towards the balance board.

Group II-Schroth Method Based Virtual Reality Group

Control Group OTHER

Participants in the control group will be placed on a waiting list for 24 weeks. Participants will not receive any exercise intervention for 24 weeks and will be able to continue their routine physical activities.

Group III-Control Group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Having been diagnosed with Adolescent Idiopathic Scoliosis by an orthopedic specialist
• Being between the ages of 10 and 15
• Risser 0-3 stage
• The Cobb angle determined on the anteroposterior radiograph should be 10-30 degrees.
• Major curvature being lumbar curvature
• No pulmonary or rib cage-related disease such as rib fracture, atelectasis, or asthma
• Ability to understand and follow instructions
• Volunteering to participate in the study

You may not qualify if:

• Using a brace
• Having received any scoliosis treatment or spine surgery within the last year
• The patient has any contraindications to exercise
• Presence of neuromuscular, orthopedic, rheumatic diseases or vestibular problems that may affect balance, vision-related diseases or mental problems.
• Another exercise or physical activity that may affect trunk muscle strength or balance
• Presence of any problem that may affect walking other than scoliosis
• Patients who cannot understand and follow instructions

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

İrem Kurt

Istanbul, 34147, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Scoliosis; Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• İrem KURT ULUSOY, PhD(C)

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

İrem KURT ULUSOY, PhD(C)

CONTACT

+905326904872; fztiremkurt@gmail.com

İpek YELDAN

CONTACT

+905326904872; iyeldan@gmail.com

Study Design

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

Study Record Dates

• First Submitted: May 12, 2024
• First Posted: May 16, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: November 1, 2025
• Last Updated: June 24, 2024

Record last verified: 2024-06

Locations

TU (1)