Balanced; RearrangementNCT06295991
The Effect of Lycra Garment on Spastic Diplegic Cerebral Palsy Individuals With Scoliosis
A study testing Lycra garment in people with Balanced; Rearrangement and Respiratory Function Test, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Balanced; Rearrangement, Respiratory Function Test
- What is being tested?
- Lycra garment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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 (18),
- Not having undergone scoliosis surgery,
- Cobb angle to be between 10-40 degrees,
- To be receiving physiotherapy appropriate to the functional status for at least 6 months.
Who cannot join
- Psychiatric disorders,
- Having a communication problem at a level that cannot adapt to the physiotherapist's instructions,
- To have undergone scoliosis surgery,
- Uncontrolled epilepsy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Lycra Garment on Balance and Respiratory Functions in Spastic Diplegic Cerebral Palsy Individuals With Scoliosis
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.
Read the detailed description
H.3. 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 infant's 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 group/placebo 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 physiotherapist's 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 person's 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 person's 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.
- Conditions
- Balanced; Rearrangement, Respiratory Function Test
- Being tested
- Lycra garment
- Keywords
- lycra garment, diplegic cerebral palsy, balance, respiratory function, scoliosis
- Medical subject headings
- Cerebral Palsy, Respiratory Aspiration, Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lycra garmentDevice
Investigation of the effect on balance and respiratory functions by using specially produced lycra garments for 6 hours a day for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | wearing lycra garment Receives: Device: Lycra garment |
| control group | Placebo comparator | wearing non-lycra garment Receives: Device: Lycra garment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance parameters
Measurement of balance control, body posture and body movement parameters using posturography
Measured: At the beginning, at the end of the eighth week and at the end of the sixteenth week
Respiratory functions
Measurement of respiratory functions like as FEV1, FVC, VC, PEF, FEV1/FVC parameters with sipirometer
Measured: At the beginning, at the end of the eighth week and at the end of the sixteenth week
Respiratory muscle strength measurement
Measurement of respiratory muscle strength as MIP/MEP parameters with Respiratory Pressure Meter (RPM)
Measured: At the beginning, at the end of the eighth week and at the end of the sixteenth week
Secondary outcomes (5)
Gross motor function measurement
Measurement of gross motor functions with "Gross Motor Function Measure-66 form"
Measured: At the beginning, at the end of the eighth week and at the end of the sixteenth week
Functional independence assessment
Assessment of functional independence with "Functional Independence Measure (FIM)"
Measured: At the beginning, at the end of the eighth week and at the end of the sixteenth week
Assessment of activity restriction
Evaluation of activity restriction with "AKTIVLIM" form
Measured: At the beginning, at the end of the eighth week and at the end of the sixteenth week
Quality of life assessment
Assessment of quality of life with "SRS-22" form
Measured: At the beginning, at the end of the eighth week and at the end of the sixteenth week
Assessment of posture
Postural assessment with "POTSI (posterior trunk symetry index)" index
Measured: At the beginning, at the end of the eighth week and at the end of the sixteenth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start1 Mar 2024
- Primary completion21 Mar 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Balanced; RearrangementStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Çelik, Hacettepe University
- Investigators
- İpek Gürbüz, Prof, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06295991
- Sponsor's protocol ID
- 2023/005
- Status last verified
- Jul 2025
- First submitted
- 22 Nov 2023
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.
PubMed 17370477Balmer GA, MacEwen GD. The incidence and treatment of scoliosis in cerebral palsy. J Bone Joint Surg Br. 1970 Feb;52(1):134-7. No abstract available.
PubMed 5436198Madigan RR, Wallace SL. Scoliosis in the institutionalized cerebral palsy population. Spine (Phila Pa 1976). 1981 Nov-Dec;6(6):583-90. doi: 10.1097/00007632-198111000-00009.
PubMed 7336281Persson-Bunke M, Hagglund G, Lauge-Pedersen H, Wagner P, Westbom L. Scoliosis in a total population of children with cerebral palsy. Spine (Phila Pa 1976). 2012 May 20;37(12):E708-13. doi: 10.1097/BRS.0b013e318246a962.
PubMed 22218299Saito N, Ebara S, Ohotsuka K, Kumeta H, Takaoka K. Natural history of scoliosis in spastic cerebral palsy. Lancet. 1998 Jun 6;351(9117):1687-92. doi: 10.1016/S0140-6736(98)01302-6.
PubMed 9734885Gu Y, Shelton JE, Ketchum JM, Cifu DX, Palmer D, Sparkman A, Jermer-Gu MK, Mendigorin M. Natural history of scoliosis in nonambulatory spastic tetraplegic cerebral palsy. PM R. 2011 Jan;3(1):27-32. doi: 10.1016/j.pmrj.2010.09.015.
PubMed 21257130Lonstein JE, Akbarnia A. Operative treatment of spinal deformities in patients with cerebral palsy or mental retardation. An analysis of one hundred and seven cases. J Bone Joint Surg Am. 1983 Jan;65(1):43-55. No abstract available.
PubMed 6848534Terjesen T, Lange JE, Steen H. Treatment of scoliosis with spinal bracing in quadriplegic cerebral palsy. Dev Med Child Neurol. 2000 Jul;42(7):448-54. doi: 10.1017/s0012162200000840.
PubMed 10972416Miller A, Temple T, Miller F. Impact of orthoses on the rate of scoliosis progression in children with cerebral palsy. J Pediatr Orthop. 1996 May-Jun;16(3):332-5. doi: 10.1097/00004694-199605000-00007.
PubMed 8728632Olafsson Y, Saraste H, Al-Dabbagh Z. Brace treatment in neuromuscular spine deformity. J Pediatr Orthop. 1999 May-Jun;19(3):376-9.
PubMed 10344323Kubat O, Ovadia D. Frontal and sagittal imbalance in patients with adolescent idiopathic deformity. Ann Transl Med. 2020 Jan;8(2):29. doi: 10.21037/atm.2019.10.49.
PubMed 32055620de Santiago HA, Reis JG, Gomes MM, da Silva Herrero CF, Defino HL, de Abreu DC. The influence of vision and support base on balance during quiet standing in patients with adolescent idiopathic scoliosis before and after posterior spinal fusion. Spine J. 2013 Nov;13(11):1470-6. doi: 10.1016/j.spinee.2013.03.027. Epub 2013 Apr 25.
PubMed 23623510Massery M. Chest development as a component of normal motor development: implications of pediatric physical therapists. Pediatr Phys Ther. 1991;3(1):3-8.
Moerchen V. Respiration and motor development: a systems perspective. Neurol Rep. 1994;18:8-10.
Kotwicki T, Jozwiak M. Conservative management of neuromuscular scoliosis: personal experience and review of literature. Disabil Rehabil. 2008;30(10):792-8. doi: 10.1080/09638280801889584.
PubMed 18432437
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lycra Garment on Balance and Respiratory Functions in Spastic Diplegic Cerebral Palsy Individuals With Scoliosis
- ClinicalTrials.gov ID
- NCT06295991
- Acronym / sponsor ID
- 2023/005
- Conditions
- Balanced; Rearrangement, Respiratory Function Test
- Keywords
- lycra garment, diplegic cerebral palsy, balance, respiratory function, scoliosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 21 Mar 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
H.3. 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 infant's 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 group/placebo 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 physiotherapist's 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 person's 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 person's 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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Device: Lycra garmentwearing lycra garment |
| control group | Placebo comparator | Device: Lycra garmentwearing non-lycra garment |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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 (18),
- Not having undergone scoliosis surgery,
Key exclusion criteria (4 listed)
- Psychiatric disorders,
- Having a communication problem at a level that cannot adapt to the physiotherapist's instructions,
- To have undergone scoliosis surgery,
- Uncontrolled epilepsy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lycra garmentInvestigation of the effect on balance and respiratory functions by using specially produced lycra garments for 6 hours a day for 16 weeks | Device | control group, study group |
Primary outcome
Balance parameters
Time frame: At the beginning, at the end of the eighth week and at the end of the sixteenth week
Measurement of balance control, body posture and body movement parameters using posturography
Respiratory functions
Time frame: At the beginning, at the end of the eighth week and at the end of the sixteenth week
Measurement of respiratory functions like as FEV1, FVC, VC, PEF, FEV1/FVC parameters with sipirometer
Respiratory muscle strength measurement
Time frame: At the beginning, at the end of the eighth week and at the end of the sixteenth week
Measurement of respiratory muscle strength as MIP/MEP parameters with Respiratory Pressure Meter (RPM)
5 secondary outcomes
Gross motor function measurement
Time frame: At the beginning, at the end of the eighth week and at the end of the sixteenth week
Functional independence assessment
Time frame: At the beginning, at the end of the eighth week and at the end of the sixteenth week
Assessment of activity restriction
Time frame: At the beginning, at the end of the eighth week and at the end of the sixteenth week
Quality of life assessment
Time frame: At the beginning, at the end of the eighth week and at the end of the sixteenth week
Assessment of posture
Time frame: At the beginning, at the end of the eighth week and at the end of the sixteenth week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Background: PubMed 17370477Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.
- Background: PubMed 5436198Balmer GA, MacEwen GD. The incidence and treatment of scoliosis in cerebral palsy. J Bone Joint Surg Br. 1970 Feb;52(1):134-7. No abstract available.
- Background: PubMed 7336281Madigan RR, Wallace SL. Scoliosis in the institutionalized cerebral palsy population. Spine (Phila Pa 1976). 1981 Nov-Dec;6(6):583-90. doi: 10.1097/00007632-198111000-00009.
- Background: PubMed 22218299Persson-Bunke M, Hagglund G, Lauge-Pedersen H, Wagner P, Westbom L. Scoliosis in a total population of children with cerebral palsy. Spine (Phila Pa 1976). 2012 May 20;37(12):E708-13. doi: 10.1097/BRS.0b013e318246a962.
- Background: PubMed 9734885Saito N, Ebara S, Ohotsuka K, Kumeta H, Takaoka K. Natural history of scoliosis in spastic cerebral palsy. Lancet. 1998 Jun 6;351(9117):1687-92. doi: 10.1016/S0140-6736(98)01302-6.
- Background: PubMed 21257130Gu Y, Shelton JE, Ketchum JM, Cifu DX, Palmer D, Sparkman A, Jermer-Gu MK, Mendigorin M. Natural history of scoliosis in nonambulatory spastic tetraplegic cerebral palsy. PM R. 2011 Jan;3(1):27-32. doi: 10.1016/j.pmrj.2010.09.015.
- Background: PubMed 6848534Lonstein JE, Akbarnia A. Operative treatment of spinal deformities in patients with cerebral palsy or mental retardation. An analysis of one hundred and seven cases. J Bone Joint Surg Am. 1983 Jan;65(1):43-55. No abstract available.
- Background: PubMed 10972416Terjesen T, Lange JE, Steen H. Treatment of scoliosis with spinal bracing in quadriplegic cerebral palsy. Dev Med Child Neurol. 2000 Jul;42(7):448-54. doi: 10.1017/s0012162200000840.
- Background: PubMed 8728632Miller A, Temple T, Miller F. Impact of orthoses on the rate of scoliosis progression in children with cerebral palsy. J Pediatr Orthop. 1996 May-Jun;16(3):332-5. doi: 10.1097/00004694-199605000-00007.
- Background: PubMed 10344323Olafsson Y, Saraste H, Al-Dabbagh Z. Brace treatment in neuromuscular spine deformity. J Pediatr Orthop. 1999 May-Jun;19(3):376-9.
- Background: PubMed 32055620Kubat O, Ovadia D. Frontal and sagittal imbalance in patients with adolescent idiopathic deformity. Ann Transl Med. 2020 Jan;8(2):29. doi: 10.21037/atm.2019.10.49.
- Background: PubMed 23623510de Santiago HA, Reis JG, Gomes MM, da Silva Herrero CF, Defino HL, de Abreu DC. The influence of vision and support base on balance during quiet standing in patients with adolescent idiopathic scoliosis before and after posterior spinal fusion. Spine J. 2013 Nov;13(11):1470-6. doi: 10.1016/j.spinee.2013.03.027. Epub 2013 Apr 25.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İpek Gürbüz, Prof principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lycra garment in people with Balanced; Rearrangement and Respiratory Function Test, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance parameters (time frame: At the beginning, at the end of the eighth week and at the end of the sixteenth week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06295991, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.