Evaluating the Effectiveness of Posture Correction Girdle for Adolescents With Early Scoliosis

NCT03929042 | Unknown

• 1 other identifier: UW16-505
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Through the ITF-Tier 3 project (ITS/ 237/ 11), a prototype of the posture correction girdle based on the clinical, textile science, material and ergonomics engineering analyses has been developed for preteen and teenage girls aged 10 to 13 who have the early stages of scoliosis. The girdle provides a corrective force onto the torso by the warping and elastic extension of the shoulder straps and waistband and the insertion of semi-rigid EVA padding and uses a point-pressure support system to achieve the target of posture improvement and spinal progression control with physical and psychological comfort. In order to evaluate the effectiveness of the posture correction girdle, it is proposed to recruit 10 patients to take low dose x-ray (sterEOS) at QMH at supine position. Then, the patient should wear the girdle for two hours and take another x-ray at standing position. If the Cobb's angle of the patient on girdle at standing position can be same as her supine position. It can prove the effectiveness of the girdle.

Conditions

Adolescent Idiopathic Scoliosis

Keywords

AIS

Outcome Measures

Primary Outcomes (1)

• Measure the spinal correction of posture correction girdle and hard brace

  The Cobb angle (unit: degree) of posture correction girdle and hard brace will be compared and reported.

  2 weeks

Secondary Outcomes (6)

• Measure the pressure forces exerted by posture correction girdle and hard brace

  2 weeks

• Measure the spinal correction of posture correction girdle after 6 months

  6 months

• Measure the pressure changes of posture correction girdle after 6 months

  6 months

• Measurement of patient-related outcome of posture correction girdle and hard brace by EQ-5D-5L

  6 months

• Measurement of patient-related outcome of posture correction girdle and hard brace by SRS-22

  6 months

Study Arms (1)

Posture Correction Girdle

EXPERIMENTAL

Our research team has designed a prototype of posture correction girdle based on the clinical, textile science, material and ergonomics engineering analyses as an alternative to hard brace for AIS. The design of the posture correction girdle incorporates different mechanisms, such as 1) compression and pulling forces through a close fit of the intimate apparel, 2) lumbar flexion by using supporting belt, 3) transverse forces applied by inserting pads inside the pocket lining by using the principle of the 3-point pressure system.

Device: Posture correction girdle

Interventions

Posture correction girdle DEVICE

Our research team has designed a prototype of posture correction girdle based on the clinical, textile science, material and ergonomics engineering analyses as an alternative to hard brace for AIS. The design of the posture correction girdle incorporates different mechanisms, such as 1) compression and pulling forces through a close fit of the intimate apparel, 2) lumbar flexion by using supporting belt, 3) transverse forces applied by inserting pads inside the pocket lining by using the principle of the 3-point pressure system.

Posture Correction Girdle

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Satisfy SRS criteria for bracing15
• Curretly treated for rigid underarm brace
• Primary Cobb angle between 25 to 40 degrees

You may not qualify if:

• Contraindications for x-ray exposure
• Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature
• History of previous surgical or orthotic treatment for AIS
• Contraindications for pulmonary and / or exercise tests
• Psychiatric disorders
• Recent trauma
• Recent traumatic (emotional) event

Sponsors & Collaborators

• The University of Hong Kong: lead
• The Hong Kong Polytechnic University: collaborator

Study Sites (1)

Duchess of Kent Children's Hospital

Hong Kong, Hong Kong

RECRUITING

Study Officials

• Prof Kenneth Cheung, MBBS (UK), MD (HK)

  The University of Hong Kong

  STUDY CHAIR

Central Study Contacts

Kenny Kwan, BMBCh (Oxon)

CONTACT

+852 22554654; kyhkwan@hku.hk

Ms Amy Cheung, MA

CONTACT

+852 22554654; amycheung114@ortho.hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Patients currently on underarm brace treatment will be eligible for participation in our study. For those that agree to participate, a AP/lat standing X-ray and force measurements of the brace on the rib and loin hump will be taken. They will be then be asked to wear a customised postural correction girdle 24 hours after they have taken off the brace. The same study assessments will be conducted. Patients whose forces and radiological Cobb correction are comparable between the two methods of treatment will be given a choice to either continue the hard brace or wear the posture correction girdle.

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: April 26, 2019
• Study Start: July 17, 2017
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2023
• Last Updated: November 18, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)