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Clinical Trials/NCT04357561
NCT04357561
Unknown
Not Applicable

Investigation of The Effects of Scoliosis Specific Exercises Before Adolescent Idiopathic Scoliosis Surgery

Marmara University1 site in 1 country30 target enrollmentFebruary 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adolescent Idiopathic Scoliosis
Sponsor
Marmara University
Enrollment
30
Locations
1
Primary Endpoint
Functional performance
Last Updated
6 years ago

Overview

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.

Detailed Description

30 adolescent idiopathic scoliosis patients, who had surgery indication and aged between 10-18 years, will be included. The participants will be randomised into two groups. 15 patients will be included in the exercise group and 15 patients in the control group. In the exercise group, a total of 12 sessions of exercise are planned, 6 weeks before the surgery and 2 days per week. In the control group, the exercise protocol will not be performed before surgery. The outcomes will include the cosmetic deformity, quality of life, pain level, functional capacity, spine flexibility. In the exercise group, the evaluations will be made in the first interview (before exercise application), at the end of 6 weeks of exercise (when the exercise program is completed), in the early postoperative period and 12 weeks after surgery. Evaluations in the control group will be carried out at the first interview, at the 6th week, in the early postoperative period, and at the 12th week postoperatively.

Registry
clinicaltrials.gov
Start Date
February 1, 2020
End Date
December 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tugce Ozen

Research Assistant

Marmara University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Functional performance

Time Frame: Change from baseline at week 6, postoperative 4.week, postoperative 12.week

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.

Pain perception

Time Frame: Change from baseline at week 6, postoperative 4.week, postoperative 12.week

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

Trunk rotation

Time Frame: Change from baseline at week 6, postoperative 4.week, postoperative 12.week

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.

Spine flexibility

Time Frame: Change from baseline at week 6, postoperative 4.week, postoperative 12.week

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.

Health related quality of life

Time Frame: Change from baseline at week 6, postoperative 4.week, postoperative 12.week

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.

Cosmetic deformity perception

Time Frame: Change from baseline at week 6, postoperative 4.week, postoperative 12.week

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.

Study Sites (1)

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