The Effect of Lycra Garment on Spastic Diplegic Cerebral Palsy Individuals With Scoliosis

NCT06295991 | Completed DMC

• 1 other identifier: 2023/005
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Balanced; Rearrangement; Respiratory Function Test

Keywords

lycra garment; diplegic cerebral palsy; balance; respiratory function; scoliosis

Outcome Measures

Primary Outcomes (3)

• Balance parameters

  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

  Measurement of respiratory functions like as FEV1, FVC, VC, PEF, FEV1/FVC 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

  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 Outcomes (5)

• Gross motor function measurement

  At the beginning, at the end of the eighth week and at the end of the sixteenth week

• Functional independence assessment

  At the beginning, at the end of the eighth week and at the end of the sixteenth week

• Assessment of activity restriction

  At the beginning, at the end of the eighth week and at the end of the sixteenth week

• Quality of life assessment

  At the beginning, at the end of the eighth week and at the end of the sixteenth week

• Assessment of posture

  At the beginning, at the end of the eighth week and at the end of the sixteenth week

Study Arms (2)

study group

EXPERIMENTAL

wearing lycra garment

Device: Lycra garment

control group

PLACEBO COMPARATOR

wearing non-lycra garment

Device: Lycra garment

Interventions

Lycra garment DEVICE

Investigation of the effect on balance and respiratory functions by using specially produced lycra garments for 6 hours a day for 16 weeks

control group; study group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Fizyo Omurga

Konya, 42000, Turkey (Türkiye)

Location

Related Publications (27)

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MeSH Terms

Conditions

Cerebral Palsy; Respiratory Aspiration; Scoliosis

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• İpek Gürbüz, Prof

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD(s)

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: March 6, 2024
• Study Start: March 1, 2024
• Primary Completion: March 21, 2024
• Study Completion: September 30, 2024
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)