Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06295991
Status:
COMPLETED
Last Update Posted:
2024-03-06
First Post:
2023-11-22
Brief Title:
The Effect of Lycra Garments on Spastic Diplegic Cerebral Palsy Patients With Scoliosis
Sponsor:
Hacettepe University
Organization:
Hacettepe University
Study Overview
Official Title:
The Effect of Lycra Garments on Balance and Respiratory Functions in Spastic Diplegic Cerebral Palsy Patients With Scoliosis Single-blinded Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2024-10
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:
The primary aim of this study was to investigate the effects of lycra clothing on balance and respiratory functions in individuals with cerebral palsy with scoliosis and the secondary aim was to investigate the effects of lycra clothing on motor function activity limitation and quality of life in these individuals
Detailed Description:
H3 Scope Cerebral palsy CP is defined as a permanent non-progressive abnormality in motor function as a result of injury to the developing brain Spinal deformity is a common musculoskeletal problem in individuals with cerebral palsy There is a strong link between CP and the development of scoliosis It is estimated that 21 to 64 of individuals with CP have scoliosis It has also been suggested that there is an inverse relationship between the development of scoliosis and ambulation and the least mobile individuals are at the greatest risk Gu et al suggested that age was the most important risk factor but they did not find a relationship between the height and weight of children and curve progression
Two different scoliotic curve patterns have been defined in individuals with CP Group-I curves can be considered as double curves with thoracic and lumbar components and occur most commonly in individuals who can walk with minimal pelvic obliquity 7 Group-II curves are single curves in the thoracic or lumbar spine and are larger They are more common in quadriplegic individuals and almost all of them have marked pelvic obliquity
The aim of non-surgical scoliosis treatment in CP is to improve sitting control and to reduce or change curve progression without the need for surgical intervention Historical reports show that the use of supportive bracing in children with CP is poorly tolerated and ineffective There is little evidence for the use of modern bracing techniques However more recent studies suggest that braces improve sitting balance and trunk support which leads to better control of the head and neck as well as better use of the upper limbs as they do not need to support the trunk in a sitting position Evidence regarding the use of orthosis to prevent scoliotic curve progression is mixed Some authors have suggested that bracing may slow curve progression especially in young individuals with curves less than 40 degrees
In individuals with scoliosis vertebral verticalisation due to deformity changes the position of the body centre of mass line which may adversely affect postural balance and stabilisation In addition force imbalance between the spinal muscles may cause postural oscillations
Impaired respiratory function which is frequently observed in adolescents and adults with severe cerebral palsy CP is caused by underdevelopment of the upper chest wall This underdevelopment prevents chest expansion and may cause rapid and paradoxical breathing patterns Gravitational forces interact with forces generated from muscle contractions to facilitate the musculoskeletal development of an infants thorax The weak musculature of a young child with CP often cannot optimally balance gravitational forces and chest development is adversely affected The incidence of scoliosis in CP and atypical chest wall structure and function are interrelated Therefore individuals with CP and scoliosis are likely to be adversely affected in respiratory functions both due to CP and scoliosis
Method Study Type and Participants This study which is planned as a cross-sectional study aims to include 24 volunteers aged 10-18 years with CP diagnosed with scoliosis
Volunteers who agree to participate in the study will be divided into two groups lycra clothing groupplacebo group by stratified randomisation method according to age and gender Only individuals with diplegic type CP will be included in the study After randomisation the individuals in the lycra clothing group will be subjected to the assessments described below three times in total once before wearing lycra clothing prepared with special measurements once after 8 weeks of clothing use and once again after 16 weeks without clothing The individuals in the placebo group will be evaluated at the beginning 8th week and 16th week in the same order by taking special measurements and using clothes prepared in the colour of lycra clothes but not compressing the body that is from fabric that does not have lycra properties For 16 weeks individuals will be provided to wear the determined clothes for 6 hours a day
The fabric of the lycra clothing to be used in the study is an elastic fabric woven from fibres called elastane The fabric to be used will be selected from 100 lycra woven fabric In non-lycra clothes completely cotton fabric will be used In both clothing groups measurements will be taken from the individual and for lycra clothes according to the structure of scoliosis elastic bands will be applied from the convex side apex points and over the lateralised hip supported by soft antiallergic plastazote Lycra-free clothes will be produced in the same structure as lycra clothes in terms of appearance and colour but the fabric to be used will be completely cotton non-elastic and wide enough not to cover the body
In addition to the physiotherapy programmes applied for 40 minutes 2 days a week a scoliosis-specific exercise programme will be applied by the co-researcher Fatih Çelik for 20 minutes after each physiotherapy programme The family will be asked to keep a diary for clothing care and use and will be regularly checked by the researcher during the scoliosis exercise programme to be applied in addition to physiotherapy sessions The evaluations will be made by the co-researcher Kamil Yılmaz who does not know which individual wears which clothes and blinding will be applied
Inclusion criteria for study and control group Being diagnosed with spastic diplegic CP Being diagnosed with scoliosis To be between the ages of ten and eighteen Being at I-II-III level according to GMFCS classification Not having undergone scoliosis surgery Cobb angle to be between 10-40 degrees Receiving physiotherapy appropriate to the functional status for at least 6 months
Exclusion criteria for study and control group Psychiatric disorders Having a communication problem at a level that cannot adapt to the physiotherapists instructions To have undergone scoliosis surgery Having uncontrolled epilepsy
Assessments Firstly demographic information such as age height body weight and gender will be obtained
The degree of spasticity will be determined with the modified ashworth scale and recorded
Balance Assessment Posturography is a test method used to assess balance disorders This test aims to objectively measure a persons balance control body posture and movements Posturography is usually performed on a balance platform This platform is a surface equipped with pressure sensors During the test the person places their feet on the platform and performs various balance tasks Sensors detect the distribution of the persons feet and body weight on the platform and analyse this information by transmitting it to a computer
Assessment of Respiratory Functions Respiratory functions of the individuals will be measured with a spirometer using the spirometric measurement method whose validity and reliability has been proven by Finkelstein et al
Motor Function Assessment For gross motor function assessment the Gross Motor Function Measure GMFM-66 developed by Palisano et al which has validity and reliability in individuals with cerebral palsy aged 5-18 years will be used
Functional Independence Assessment Functional Independence Measure FIM whose validity and reliability have been proven for both adolescents and adults will be used
Assessment of Activity Restriction Activity limitation will be evaluated with the ACTIVLIM questionnaire developed by Vandervelde et al for use in adults and children
Quality of Life Assessment The disease-related quality of life of the individuals included in the study will be evaluated with the Scoliosis Research Society 22nd Form SRS 22r scale developed by Alanay A et al
Posture Assessment Posture will be evaluated using the POTSI posterior trunk symetry index index Its validity in scoliosis has been demonstrated
Two different scoliotic curve patterns have been defined in individuals with CP Group-I curves can be considered as double curves with thoracic and lumbar components and occur most commonly in individuals who can walk with minimal pelvic obliquity 7 Group-II curves are single curves in the thoracic or lumbar spine and are larger They are more common in quadriplegic individuals and almost all of them have marked pelvic obliquity
The aim of non-surgical scoliosis treatment in CP is to improve sitting control and to reduce or change curve progression without the need for surgical intervention Historical reports show that the use of supportive bracing in children with CP is poorly tolerated and ineffective There is little evidence for the use of modern bracing techniques However more recent studies suggest that braces improve sitting balance and trunk support which leads to better control of the head and neck as well as better use of the upper limbs as they do not need to support the trunk in a sitting position Evidence regarding the use of orthosis to prevent scoliotic curve progression is mixed Some authors have suggested that bracing may slow curve progression especially in young individuals with curves less than 40 degrees
In individuals with scoliosis vertebral verticalisation due to deformity changes the position of the body centre of mass line which may adversely affect postural balance and stabilisation In addition force imbalance between the spinal muscles may cause postural oscillations
Impaired respiratory function which is frequently observed in adolescents and adults with severe cerebral palsy CP is caused by underdevelopment of the upper chest wall This underdevelopment prevents chest expansion and may cause rapid and paradoxical breathing patterns Gravitational forces interact with forces generated from muscle contractions to facilitate the musculoskeletal development of an infants thorax The weak musculature of a young child with CP often cannot optimally balance gravitational forces and chest development is adversely affected The incidence of scoliosis in CP and atypical chest wall structure and function are interrelated Therefore individuals with CP and scoliosis are likely to be adversely affected in respiratory functions both due to CP and scoliosis
Method Study Type and Participants This study which is planned as a cross-sectional study aims to include 24 volunteers aged 10-18 years with CP diagnosed with scoliosis
Volunteers who agree to participate in the study will be divided into two groups lycra clothing groupplacebo group by stratified randomisation method according to age and gender Only individuals with diplegic type CP will be included in the study After randomisation the individuals in the lycra clothing group will be subjected to the assessments described below three times in total once before wearing lycra clothing prepared with special measurements once after 8 weeks of clothing use and once again after 16 weeks without clothing The individuals in the placebo group will be evaluated at the beginning 8th week and 16th week in the same order by taking special measurements and using clothes prepared in the colour of lycra clothes but not compressing the body that is from fabric that does not have lycra properties For 16 weeks individuals will be provided to wear the determined clothes for 6 hours a day
The fabric of the lycra clothing to be used in the study is an elastic fabric woven from fibres called elastane The fabric to be used will be selected from 100 lycra woven fabric In non-lycra clothes completely cotton fabric will be used In both clothing groups measurements will be taken from the individual and for lycra clothes according to the structure of scoliosis elastic bands will be applied from the convex side apex points and over the lateralised hip supported by soft antiallergic plastazote Lycra-free clothes will be produced in the same structure as lycra clothes in terms of appearance and colour but the fabric to be used will be completely cotton non-elastic and wide enough not to cover the body
In addition to the physiotherapy programmes applied for 40 minutes 2 days a week a scoliosis-specific exercise programme will be applied by the co-researcher Fatih Çelik for 20 minutes after each physiotherapy programme The family will be asked to keep a diary for clothing care and use and will be regularly checked by the researcher during the scoliosis exercise programme to be applied in addition to physiotherapy sessions The evaluations will be made by the co-researcher Kamil Yılmaz who does not know which individual wears which clothes and blinding will be applied
Inclusion criteria for study and control group Being diagnosed with spastic diplegic CP Being diagnosed with scoliosis To be between the ages of ten and eighteen Being at I-II-III level according to GMFCS classification Not having undergone scoliosis surgery Cobb angle to be between 10-40 degrees Receiving physiotherapy appropriate to the functional status for at least 6 months
Exclusion criteria for study and control group Psychiatric disorders Having a communication problem at a level that cannot adapt to the physiotherapists instructions To have undergone scoliosis surgery Having uncontrolled epilepsy
Assessments Firstly demographic information such as age height body weight and gender will be obtained
The degree of spasticity will be determined with the modified ashworth scale and recorded
Balance Assessment Posturography is a test method used to assess balance disorders This test aims to objectively measure a persons balance control body posture and movements Posturography is usually performed on a balance platform This platform is a surface equipped with pressure sensors During the test the person places their feet on the platform and performs various balance tasks Sensors detect the distribution of the persons feet and body weight on the platform and analyse this information by transmitting it to a computer
Assessment of Respiratory Functions Respiratory functions of the individuals will be measured with a spirometer using the spirometric measurement method whose validity and reliability has been proven by Finkelstein et al
Motor Function Assessment For gross motor function assessment the Gross Motor Function Measure GMFM-66 developed by Palisano et al which has validity and reliability in individuals with cerebral palsy aged 5-18 years will be used
Functional Independence Assessment Functional Independence Measure FIM whose validity and reliability have been proven for both adolescents and adults will be used
Assessment of Activity Restriction Activity limitation will be evaluated with the ACTIVLIM questionnaire developed by Vandervelde et al for use in adults and children
Quality of Life Assessment The disease-related quality of life of the individuals included in the study will be evaluated with the Scoliosis Research Society 22nd Form SRS 22r scale developed by Alanay A et al
Posture Assessment Posture will be evaluated using the POTSI posterior trunk symetry index index Its validity in scoliosis has been demonstrated
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