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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Turkey (Türkiye)1 site
  • Fizyo Omurga

    Konya, 42000

Other trials in Turkey (Türkiye)

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.

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 groups in NCT06295991
Study groupRoleWhat they receive
study groupExperimentalwearing lycra garment
Receives: Device: Lycra garment
control groupPlacebo comparatorwearing non-lycra garment
Receives: Device: Lycra garment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. 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

  3. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  1. First posted6 Mar 2024
  2. Study start1 Mar 2024
  3. Primary completion21 Mar 2024
  4. Study completion30 Sep 2024

Resources

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)
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 17370477
  • Balmer 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 5436198
  • Madigan 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 7336281
  • Persson-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 22218299
  • Saito 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 9734885
  • Gu 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 21257130
  • Lonstein 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 6848534
  • Terjesen 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 10972416
  • Miller 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 8728632
  • Olafsson Y, Saraste H, Al-Dabbagh Z. Brace treatment in neuromuscular spine deformity. J Pediatr Orthop. 1999 May-Jun;19(3):376-9.

    PubMed 10344323
  • Kubat 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 32055620
  • de 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 23623510
  • Massery 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

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.

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