The Effects of Scoliosis-Specific Exercises Before Surgery

NCT04357561 | Unknown

• 1 other identifier: 092019939
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the effects of scoliosis-specific exercises in adolescent idiopathic scoliosis patients, who had surgical indication, on functional capacity, cosmetic deformity perception, quality of life in postoperative period.

Conditions

Adolescent Idiopathic Scoliosis

Keywords

adolescent idiopathic scoliosis; preoperative rehabilitation; surgery

Outcome Measures

Primary Outcomes (6)

• Functional performance

  Six-minute walking test will be used. The patients will be asked to walk at his/her own pace of walking in a 30 meter course. The distance walked over a span of 6 minutes will be recorded.

  Change from baseline at week 6, postoperative 4.week, postoperative 12.week

• Pain perception

  Pain level will be evaluated with visual analog scale. Patients will be asked to indicate their pain level in activity and in rest period.

  Change from baseline at week 6, postoperative 4.week, postoperative 12.week

• Health related quality of life

  Scoliosis Research Society-30 will be used for quality of life evaluation. This questionnaire consists of 30 questions, scored between 1 and 5, and evaluate pain, function, self-image, mental health and treatment satisfaction. Pediatric Quality of Life Inventory is a self-report questionnaire developed for children and their families. consists of 22 questions and evaluate physical and psychosocial health. Higher scores indicate better quality of life.

  Change from baseline at week 6, postoperative 4.week, postoperative 12.week

• Cosmetic deformity perception

  Walter Reed Visual Assessment Scale-Walter Reed Visual Assessment Scale will be used to evaluate individuals' self-perception of cosmetic deformities and the effectiveness of treatment in improving body cosmetic deformity. It focuses on the person's perception of posture and the severity of the curve. This questionnaire is divided into 7 parameters including body curvature, rib prominence, waist prominence, head-rib-pelvis positional relation, head-pelvis relation, shoulder level and scapula rotation. Each parameter is scored from 1 to 5.

  Change from baseline at week 6, postoperative 4.week, postoperative 12.week

• Spine flexibility

  Forward bending test will be applied. The patient is asked to reach the feet with his hands while sitting on a hard floor with both feet extended, with feet 15 cm apart from each other, based on a 25 cm long step, without bringing the knees flexed. measured and saved as centimeter. Side bending test will be used to measure the flexibility of spine in right and left lateral flexion. The patient is asked to bend his back to the right and left sides, without separating his back from the wall. The result sill be recorded as centimeter.

  Change from baseline at week 6, postoperative 4.week, postoperative 12.week

• Trunk rotation

  Trunk rotation will be measured with scoliometer while the patient is in forward bending position with barefoot. The highest value in each part will be recorded.

  Change from baseline at week 6, postoperative 4.week, postoperative 12.week

Study Arms (2)

Exercise group (Schroth best practice)

EXPERIMENTAL

Exercise program will consists of scoliosis-specific exercises (schroth best practice), which is a pattern specific scoliosis rehabilitation concept and provide three dimensional improvements and include patient education for maintaining corrected posture in daily life. In addition, these exercises provide improvements in neuromuscular control and the endurance of the postural muscles.

Behavioral: Exercise group (Schroth best practice)

Control group

NO INTERVENTION

Due to there is not a standard preoperative exercise protocol, additional exercise program will not be applied in control group. The patients will wait for the surgery in their routine daily life. Measurements will be performed at the same time frame in experimental group.

Interventions

Exercise group (Schroth best practice) BEHAVIORAL

Exercise program will be structured with scoliosis specific exercises (schroth best practice). Schroth best pratice is a pattern spesific scoliosis rehabilitation concept which aimes active self correction during curve pattern specific curve activities of daily life. Exercises for rotational breathing, everyday activities, spinal mobilization and corrective exercises will be specified based on the curve type and applied under the supervision of a physiotherapist.

Exercise group (Schroth best practice)

Eligibility Criteria

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

You may qualify if:

• Diagnosed with adolescent idiopathic scoliosis
• Aged between 10 and 18 years
• To have surgery indication

You may not qualify if:

• Leg discrepancy
• Cervical region participation to curve
• Additional disease may cause respiratory problem

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, 34000, Turkey (Türkiye)

RECRUITING

Study Officials

• Tugce Ozen, MSc

  Research Assistant

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tugce Ozen, MSc

CONTACT

5052275829; tugceozen1709@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 22, 2020
• Study Start: February 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 22, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)