- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04357561
The Effects of Scoliosis-Specific Exercises Before Surgery
Investigation of The Effects of Scoliosis Specific Exercises Before Adolescent Idiopathic Scoliosis Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Istanbul, Turkey, 34000
- Recruiting
- Marmara University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise group (Schroth best practice)
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.
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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.
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No Intervention: Control group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional performance
Time Frame: Change from baseline at week 6, postoperative 4.week, postoperative 12.week
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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.
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Change from baseline at week 6, postoperative 4.week, postoperative 12.week
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Pain perception
Time Frame: Change from baseline at week 6, postoperative 4.week, postoperative 12.week
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Pain level will be evaluated with visual analog scale.
Patients will be asked to indicate their pain level in activity and in rest period.
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Change from baseline at week 6, postoperative 4.week, postoperative 12.week
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Health related quality of life
Time Frame: Change from baseline at week 6, postoperative 4.week, postoperative 12.week
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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
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Cosmetic deformity perception
Time Frame: Change from baseline at week 6, postoperative 4.week, postoperative 12.week
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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.
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Change from baseline at week 6, postoperative 4.week, postoperative 12.week
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Spine flexibility
Time Frame: Change from baseline at week 6, postoperative 4.week, postoperative 12.week
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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
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Trunk rotation
Time Frame: Change from baseline at week 6, postoperative 4.week, postoperative 12.week
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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.
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Change from baseline at week 6, postoperative 4.week, postoperative 12.week
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tugce Ozen, MSc, Research Assistant
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 092019939
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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