Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06170112
Status:
RECRUITING
Last Update Posted:
2023-12-14
First Post:
2023-11-28
Brief Title:
Evaluation Of The Effect Of Spinal Orthosis On Tactile Sense And Balance In Individuals With Lumbal Curve And Adolescent Idiopathic Scoliosis
Sponsor:
Istanbul Medipol University Hospital
Organization:
Istanbul Medipol University Hospital
Study Overview
Official Title:
Evaluation Of The Effect Of Spinal Orthosis On Tactile Sense And Balance In Individuals With Lumbal Curve And Adolescent Idiopathic Scoliosis
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In individuals with lumbar curvature significant regressions in the curvature have been observed with spinal orthosis treatment especially with use of a minimum of 20 hours a day Symptoms such as numbness and decreased sense of touch are observed in the areas where the curvature is located and changes in the skin structure are affected by the changes in the spine Sensory testing may vary with changes in body posture At the same time the use of spinal orthosis balance fat mass and the presence of pain show us sensitivity to touch on the skin Sensory stimuli on the skin and trunk posture are interconnected There are a limited number of studies in the literature examining the effects of sensory test results and fat mass on individuals diagnosed with AIS after using a spinal orthosis
Detailed Description:
The purpose of this study is to examine how spinal orthoses affect lumbar curvature tactile sensation dynamic balance skinfold thickness and quality of life in people with adolescent idiopathic scoliosis The 40 participants in the study will be between the ages of 10 and 18 with Cobb angles ranging from 20 to 45 degreesConsent forms will be obtained from all participants and parents participating in the study
Semmes Weinstein Monofilament kit will be used to measure participants sense of touch Skinfold Caliper to measure subcutaneous fat tissue Y-Balance Test for Dynamic Balance and Scoliosis Research Society 22 SRS-22 Evaluation Questionnaire Measurements will be recorded before the birth of the corset and 12 weeks after the start of corset use At the end of the 12th week the brace will be evaluated for satisfaction with the Brace Questionnaire BRQ
Socio- demographic form information will be given at the first interview In addition to the anamnesis this form includes questions about whether the person exercises or not whether there is a family member diagnosed with scoliosis and the doctors instructions for use of the orthosis
Sense of Touch Assessment- Semmes Weinstein Monofilament Kit will be used in the study This test is one of the tests commonly used to evaluate light touch sensation Although it is mostly used in the palmar area it is also used in certain parts of the body to test light touch sensation Semmes-Weinstein Monofilament test is performed using filaments of different diameters with the same length The thicknesses of the filaments are 283 322 361 384 and 431 As the filament diameter thickens the pressure given and the sensory input given increase accordingly In the study in individuals diagnosed with adolescent idiopathic scoliosis and with lumbar curvature these filaments will be applied to two different regions of the curvature concave and convex at T10 L4 and L5 in order from thinnest to thickest The number of the first monofilament felt will be recorded Pressure will be applied until the 283 mm monofilament which has the thinnest diameter is curled the person will be asked whether heshe feels the pressure and if not the application will continue by increasing the filament thickness accordingly
Fat Tissue Measurement- Skinfold Caliper thickness measurement is performed to determine the fat tissue under the skin A significant part of the fat in the body is collected under the skin The thickness of the skinfold is evaluated with a special caliper called skinfold Measurement is made by holding the skin and subcutaneous tissue with the thumb and index finger and pulling the natural skin piece away from the muscle It is read in millimeters from the caliper indicator Measurement of the evaluated area should be done twice and if the difference is more than 2 mm the measurement should be repeated The body parts measured can be listed as triceps biceps subscapula suprailiaca front of the thigh inner side of the calf abdomen chest and midaxilla It is known that low body fat is a risk factor for the onset of scoliosis In our study fat tissue measurements will be made in the axilla abdominal suscapular and suprailiac regions
Dynamic Balance- Y Balance Test After the foot of the party to be tested is placed behind the red line on the platform they will be asked to push the distance indicator in all three directions anterior postromedial and posterolateral as far as possible with the foot in the air After two trials are made in each direction before the test three measurements will be taken for each direction during the test phase For each direction the total score obtained by dividing the best value of the three maximum distances by the leg length and multiplying by 100 will be calculated and noted The test will be terminated when the person lifts the heel of the tested foot standing on the platform to maintain balance during the test loses contact with the distance indicator uses it as support to restore the lost balance and cannot return to the starting position
Scoliosis Research Societys Health-related Quality of Life- 22 SRS-22 survey form It is a quality of life questionnaire created specifically for individuals diagnosed with scoliosis It includes parameters of pain self-appearance function-activity mental health and satisfaction with treatment It also has a role in evaluating changes within treatment It will be filled in by the researcher together with the patient It will be calculated by giving an answer value to all 22 questions within a 5-point indicator chart Each statement has responses ranging from negative to positive The most negative answer will be scored as 1 point and the most positive answer will be scored as 5 points All questions will be evaluated under the total result score
Brace Questionnaire BRQ- Recording the evaluation of brace treatment and the feedback from the patient gives the clinician objective information about choosing the right treatment method It consists of 34 questions grouped under 8 main headings The domains include general health perception physical functioning emotional functioning self-confidence and aesthetics vitality school activity body pain and social functioning The score of each question between 1 and 5 is multiplied by 20 to reach the final score and higher scores indicate a better quality of life Since it questions the effect of corset use on many parameters in a versatile way it offers us an idea about the quality of life with corset in a practical and easy way
Semmes Weinstein Monofilament kit will be used to measure participants sense of touch Skinfold Caliper to measure subcutaneous fat tissue Y-Balance Test for Dynamic Balance and Scoliosis Research Society 22 SRS-22 Evaluation Questionnaire Measurements will be recorded before the birth of the corset and 12 weeks after the start of corset use At the end of the 12th week the brace will be evaluated for satisfaction with the Brace Questionnaire BRQ
Socio- demographic form information will be given at the first interview In addition to the anamnesis this form includes questions about whether the person exercises or not whether there is a family member diagnosed with scoliosis and the doctors instructions for use of the orthosis
Sense of Touch Assessment- Semmes Weinstein Monofilament Kit will be used in the study This test is one of the tests commonly used to evaluate light touch sensation Although it is mostly used in the palmar area it is also used in certain parts of the body to test light touch sensation Semmes-Weinstein Monofilament test is performed using filaments of different diameters with the same length The thicknesses of the filaments are 283 322 361 384 and 431 As the filament diameter thickens the pressure given and the sensory input given increase accordingly In the study in individuals diagnosed with adolescent idiopathic scoliosis and with lumbar curvature these filaments will be applied to two different regions of the curvature concave and convex at T10 L4 and L5 in order from thinnest to thickest The number of the first monofilament felt will be recorded Pressure will be applied until the 283 mm monofilament which has the thinnest diameter is curled the person will be asked whether heshe feels the pressure and if not the application will continue by increasing the filament thickness accordingly
Fat Tissue Measurement- Skinfold Caliper thickness measurement is performed to determine the fat tissue under the skin A significant part of the fat in the body is collected under the skin The thickness of the skinfold is evaluated with a special caliper called skinfold Measurement is made by holding the skin and subcutaneous tissue with the thumb and index finger and pulling the natural skin piece away from the muscle It is read in millimeters from the caliper indicator Measurement of the evaluated area should be done twice and if the difference is more than 2 mm the measurement should be repeated The body parts measured can be listed as triceps biceps subscapula suprailiaca front of the thigh inner side of the calf abdomen chest and midaxilla It is known that low body fat is a risk factor for the onset of scoliosis In our study fat tissue measurements will be made in the axilla abdominal suscapular and suprailiac regions
Dynamic Balance- Y Balance Test After the foot of the party to be tested is placed behind the red line on the platform they will be asked to push the distance indicator in all three directions anterior postromedial and posterolateral as far as possible with the foot in the air After two trials are made in each direction before the test three measurements will be taken for each direction during the test phase For each direction the total score obtained by dividing the best value of the three maximum distances by the leg length and multiplying by 100 will be calculated and noted The test will be terminated when the person lifts the heel of the tested foot standing on the platform to maintain balance during the test loses contact with the distance indicator uses it as support to restore the lost balance and cannot return to the starting position
Scoliosis Research Societys Health-related Quality of Life- 22 SRS-22 survey form It is a quality of life questionnaire created specifically for individuals diagnosed with scoliosis It includes parameters of pain self-appearance function-activity mental health and satisfaction with treatment It also has a role in evaluating changes within treatment It will be filled in by the researcher together with the patient It will be calculated by giving an answer value to all 22 questions within a 5-point indicator chart Each statement has responses ranging from negative to positive The most negative answer will be scored as 1 point and the most positive answer will be scored as 5 points All questions will be evaluated under the total result score
Brace Questionnaire BRQ- Recording the evaluation of brace treatment and the feedback from the patient gives the clinician objective information about choosing the right treatment method It consists of 34 questions grouped under 8 main headings The domains include general health perception physical functioning emotional functioning self-confidence and aesthetics vitality school activity body pain and social functioning The score of each question between 1 and 5 is multiplied by 20 to reach the final score and higher scores indicate a better quality of life Since it questions the effect of corset use on many parameters in a versatile way it offers us an idea about the quality of life with corset in a practical and easy way
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None