The Effect of Lycra Garments on Spastic Diplegic Cerebral Palsy Patients With Scoliosis

February 28, 2024 updated by: Fatih Çelik, Hacettepe University

The Effect of Lycra Garments on Balance and Respiratory Functions in Spastic Diplegic Cerebral Palsy Patients With Scoliosis: Single-blinded, Randomized Controlled Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Psychiatric disorders,
  • Having a communication problem at a level that cannot adapt to the physiotherapist's instructions,
  • To have undergone scoliosis surgery,
  • Uncontrolled epilepsy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: study group
wearing lycra garment
Device: Lycra garment
Investigation of the effect on balance and respiratory functions by using specially produced lycra garments for 6 hours a day for 16 weeks
Placebo Comparator: control group
wearing non-lycra garment
Device: Lycra garment
Investigation of the effect on balance and respiratory functions by using specially produced lycra garments for 6 hours a day for 16 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At the beginning, at the end of the eighth week and at the end of the sixteenth week
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, TV parameters with sipirometer
At the beginning, at the end of the eighth week and at the end of the sixteenth week
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)
At the beginning, at the end of the eighth week and at the end of the sixteenth week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gross motor function measurement
Time Frame: At the beginning, at the end of the eighth week and at the end of the sixteenth week
Measurement of gross motor functions with "Gross Motor Function Measure-66 form"
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 functional independence with "Functional Independence Measure (FIM)"
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
Evaluation of activity restriction with "AKTIVLIM" form
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 quality of life with "SRS-22" form
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
Postural assessment with "POTSI (posterior trunk symetry index)" index
At the beginning, at the end of the eighth week and at the end of the sixteenth week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Investigators

  • Principal Investigator: İpek Gürbüz, Prof, Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

March 21, 2024

Study Completion (Estimated)

July 30, 2024

Study Registration Dates

First Submitted

November 22, 2023

First Submitted That Met QC Criteria

February 28, 2024

First Posted (Estimated)

March 6, 2024

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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