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The Effects of Scoliosis-Specific Exercises Before Surgery

Primary Purpose

Adolescent Idiopathic Scoliosis

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise group (Schroth best practice)
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adolescent Idiopathic Scoliosis focused on measuring adolescent idiopathic scoliosis, preoperative rehabilitation, surgery

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Marmara UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise group (Schroth best practice)

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 15, 2020
Last Updated
April 21, 2020
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT04357561
Brief Title
The Effects of Scoliosis-Specific Exercises Before Surgery
Official Title
Investigation of The Effects of Scoliosis Specific Exercises Before Adolescent Idiopathic Scoliosis Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Idiopathic Scoliosis
Keywords
adolescent idiopathic scoliosis, preoperative rehabilitation, surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise group (Schroth best practice)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise group (Schroth best practice)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional performance
Description
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.
Time Frame
Change from baseline at week 6, postoperative 4.week, postoperative 12.week
Title
Pain perception
Description
Pain level will be evaluated with visual analog scale. Patients will be asked to indicate their pain level in activity and in rest period.
Time Frame
Change from baseline at week 6, postoperative 4.week, postoperative 12.week
Title
Health related quality of life
Description
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.
Time Frame
Change from baseline at week 6, postoperative 4.week, postoperative 12.week
Title
Cosmetic deformity perception
Description
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.
Time Frame
Change from baseline at week 6, postoperative 4.week, postoperative 12.week
Title
Spine flexibility
Description
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.
Time Frame
Change from baseline at week 6, postoperative 4.week, postoperative 12.week
Title
Trunk rotation
Description
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.
Time Frame
Change from baseline at week 6, postoperative 4.week, postoperative 12.week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tugce Ozen, MSc
Phone
5052275829
Email
tugceozen1709@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tugce Ozen, MSc
Organizational Affiliation
Research Assistant
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marmara University
City
Istanbul
ZIP/Postal Code
34000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tugce Ozen, MSc
Phone
5052275829
Email
tugceozen1709@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effects of Scoliosis-Specific Exercises Before Surgery

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