The effectiveness of bracing with home-based exercise aids on spinal deformity, pulmonary function, trunk muscle endurance and quality of life in adolescents idiopathic scoliosis: A parallel-groups clinical study
The aim of this study was to evaluate the effectiveness of bracing with home-based exercise aids on spinal deformity, pulmonary function, trunk muscle endurance and quality of life in adolescents idiopathic scoliosis in comparison with braces alone.
Design
The study is a single-blind randomized clinical trial with parallel groups. A total of 16 samples are selected using data from previous studies. participants enter each of the study groups through the blocked randomization method.
Settings and conduct
Participants are selected from patients referred to orthopedic centers affiliated to Isfahan University of Medical Sciences through available sampling.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: 1) Diagnosis of idiopathic scoliosis by a specialist. 2) Risser sign 0-2. 3) Thoracolumbar or lumbar curve 20-45 degrees. 4) Single or C-type curves. 5) Ability to use of braces and home-based exercise aids. 6) Physician approval to participate in research.
Exclusion Criteria: 1. Existence of shortness and defects in the lower extremities. 2. People with underlying neuromuscular diseases such as cerebral palsy, spina bifida, muscular dystrophy, congenital myopathy and any other disease that is not able to exercise. 3. People with any history of surgery, trauma, fractures and other injuries to the spine. 4. Patients who have not experienced any intervention or practice for at least the past year.
Intervention groups
The test group will receive (a combination of brace and home exercise aids) and control (use of braces and scoliosis exercise program at home).
Main outcome variables
Spine Cobb angle, pulmonary function factors, trunk muscle endurance score, quality of life score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220330054371N1
Registration date:2022-05-09, 1401/02/19
Registration timing:prospective
Last update:2022-05-09, 1401/02/19
Update count:0
Registration date
2022-05-09, 1401/02/19
Registrant information
Name
Zeinab Rezaeian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 4272 1266
Email address
rezaeian.zeinab.236@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-06, 1401/04/15
Expected recruitment end date
2023-01-20, 1401/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of bracing with home-based exercise aids on spinal deformity, pulmonary function, trunk muscle endurance and quality of life in adolescents idiopathic scoliosis: A parallel-groups clinical study
Public title
The effectiveness of bracing with home-based exercise aids on spinal deformity of life in adolescents idiopathic scoliosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of idiopathic scoliosis by a specialist
Risser sign 0-2
Thoracolumbar or lumbar curve 20-45 degrees
Single or C-type curves
Ability to use of braces and home-based exercise aids
Physician approval to participate in research
Exclusion criteria:
Existence of shortness and defects in the lower extremities
People with underlying neuromuscular diseases such as cerebral palsy, spina bifida, muscular dystrophy, congenital myopathy and any other disease that is not able to exercise
People with any history of surgery, trauma, fractures and other injuries to the spine
Age
From 11 years old to 17 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
16
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the samples are placed in a block randomization method with the aim of entering equal samples in each group. The method of random appointment in both groups is that the size of each block is 4 people and based on this and considering the two test groups (T) and control group (C), 6 blocks are obtained. The arrangement of the members of each block is (TTCC), (TCCT), (TCTC), (CCTT), (CTTC) and (CTCT). The blocks are randomly selected and individuals receive the desired treatment based on the order of inclusion criteria in the study.
Blinding (investigator's opinion)
Single blinded
Blinding description
The measurement of curve angle will be carried out using blind assessors. The assessors will measure the curve angle while they are unaware of group allocations and personal details.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2022-04-24, 1401/02/04
Ethics committee reference number
IR.MUI.NUREMA.REC.1401.025
Health conditions studied
1
Description of health condition studied
Lateral spinal deviation with idiopathic cause in adolescents in thoracolumbar and lumbar region
ICD-10 code
M41.125
ICD-10 code description
Adolescent idiopathic scoliosis, thoracolumbar region
Primary outcomes
1
Description
The amount of Cobb angle in the spine
Timepoint
This variable is measured in two sessions. The first time, the measurement is done in the pre-test stage (before the intervention). Then we ask the person to use braces and exercises for three months. After three months, the relevant variable is measured for the second time in the post-test phase.
Method of measurement
To measure the angle of the cobb, the patient's spine with anterior-posterior view is used while standing in a normal position. The calculation is done manually with the help of a pencil and a conveyor. Cobb angle is the angle created between two lines perpendicular to the upper plateau of the upper vertebra of the scoliotic deviation and the line perpendicular to the lower plateau of the lower vertebra of the scoliotic deviation. On the other hand, because the intersection point is often somewhere off the page, an alternative method is used. Draw a right perpendicular to the two tangent lines and the angle created by the intersection of the two perpendicular lines is the angle of the cobb.
2
Description
Evaluation of pulmonary function
Timepoint
This variable is measured in two sessions. The first time, the measurement is done in the pre-test stage (before the intervention). Then we ask the person to use braces and exercises for three months. After three months, the relevant variable is measured for the second time in the post-test phase.
Method of measurement
Pulmonary function will be assessed by spirometry test using a Japanese CHESTGRAPH HI-301 digital spirometer. After giving personal information to the device and calibrating it, the tests of Total Lung Capacity, Vital Capacity, Forced Vital Capacity, Vital Capacity Inspiratory , Vital Capacity Expiratory, Peak Expiratory Flow and Forced Expiratory Volume In One Second , respectively. This test is performed while sitting on a chair and the patient is asked to remove the brace at least 2 hours before the test. To measure spirometric Indicators, a person is first asked to perform a normal inspiration. The mouthpiece of the device is immediately placed in his mouth and he takes a deep Expiration. The person then takes a deep inspiration, takes a deep Expiration, and then a deep inspiration, and the experiment ends at the end of this deep inspiration. During the test, care will be taken not to separate the input of the device from the mouth. Also, there should be no interruption between her inspiration and Expiration, and the duration of a deep Expiration should last at least 6 seconds. The alarm device alarm will be used for sufficient air.
3
Description
The endurance of the trunk muscles
Timepoint
This variable is measured in two sessions. The first time, the measurement is done in the pre-test stage (before the intervention). Then we ask the person to use braces and exercises for three months. After three months, the relevant variable is measured for the second time in the post-test phase.
Method of measurement
Trunk muscle endurance is assessed by lumbar trunk endurance test or LTMET to assess flexor and extensor trunk endurance and Side-Bridge test to assess lateral trunk flexor endurance. Finally, the Time (s) of Maintain position for each test in both groups can be recorded and compared.
4
Description
Quality of life index
Timepoint
This variable is measured in two sessions. The first time, the measurement is done in the pre-test stage (before the intervention). Then we ask the person to use braces and exercises for three months. After three months, the relevant variable is measured for the second time in the post-test phase.
Method of measurement
Quality of life index is measured by ISYQOL questionnaire which has 13 questions in the field of spinal health. The answers to the questions are based on a 3-point scale (zero to 2) in 3 options (never, sometimes, often). Thus, the score of each question will be between 0 and 2 and the range of total numerical scores will be between 0 and 26 for spinal health. That is, the number zero will be the highest quality of life and the number 26 will be the lowest level of quality of life.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Combination of brace and home-based exercise aid, Cheanue brace: Cheanue is a short piece of thoracolumbosacral brace, made of polypropylene, which opens and closes from the front. By conveying a load on the convex side, the brace directs the spine to the large valves on the wall in all three planes of motion, allowing the patient to perform therapeutic exercises for at least one hour a day. Braces are made specifically by molding the patient's spine. Cantilever Device: A rigid framework consists of levers that increase the mechanical advantage of the device by increasing its length. The corrective mechanism of the system is three points of pressure in which it is done by applying transverse load by pads to the spine to achieve a reduction in deviation. The pads in the device are made of polyurethane and its size depends on the size of the patient. The thoracic pad is fitted on the convex side of the deflection and on the gear that is articulated to the vertex of the deflection and its lower gear. The lumbar pad is also placed between the lower ribs and the upper iliac crest.
Category
Treatment - Devices
2
Description
Control group: Use braces and scoliosis exercise program at home. Cheanue brace: Cheanue is a short piece of thoracolumbosacral brace, made of polypropylene, which opens and closes from the front. By conveying a load on the convex side, the brace directs the spine to the large valves on the wall in all three planes of motion, allowing the patient to perform therapeutic exercises for at least one hour a day. Braces are made specifically by molding the patient's spine. scoliosis exercise program at home: The exercises in the control group are designed for patients by a therapist and the patient is taught how and when to perform and repeat the exercises orally and in the form of a logbook.