Active Bodysuits for Adult Degenerative Scoliosis

Scoliosis Clinical Trial

Official title:

Effectiveness of Active Bodysuits for Adult Degenerative Scoliosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04509310
• Other study ID #: UW19-026
• Status: Recruiting
• Phase: N/A
• Start date: January 6, 2019
• Est. completion date: December 2022

Study information

• Verified date: September 2021
• Source: The University of Hong Kong
• Contact: Dr Kenny Kwan, BMBCh (Oxon)
• Phone: +852 22554654
• Email: kyhkwan[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Adult degenerative (de novo) scoliosis (ADS) is a condition of the ageing population caused by degenerative changes without pre-existing spinal deformity. Pain is the most frequent problem, especially low back pain and radicular pain, and seriously affects the daily activities and health of ADS patients. The current treatment for ADS is not well defined. The main intervention for ADS treatment is surgical, but surgery is clearly not appropriate for every patient. Active bodysuits will be designed based on body alignment and pain management using special design components and incorporating active posture training from a biofeedback system. Back pain is often localized along the convexity of the curve, and passive support to the areas of pain, most likely in the lower trunk, hip and lower extremities, should be provided.

Description:

The potential materials that can provide support are 3D printable rigid materials, semirigid foam padding, Velcro tape and stretchable wide waistbands. The 3D printable materials can be very versatile in terms of properties and can be further finished with an epoxy resin or thermoplastics. Different compositions and structures of knitted fabrics will be used in different areas of the proposed bodysuits to provide a close fit, high breathability and effective pain management due to extra support. The fastening system includes a magnetic zipper and pulley system that can be adjusted by pulling on knobs. The pulley system contains a microadjustable dial, super-strong lightweight lacing, and low friction lacing guides.

Other known NCT identifiers

• NCT03332277

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adults diagnosed with degenerative scoliosis
• Cobb's angle greater than 25 degrees
• Chronic lower back pain
• Limited mobility due to degenerative scoliosis

Exclusion Criteria:

• Substantial cardiac, pulmonary, renal or metabolic disease
• Neuromuscular scoliosis (e.g., spinal muscular atrophy, cerebral palsy, Parkinson's Disease, post-polio syndrome, Charcot Marie Tooth disease)
• Spine tumor, infection or connective tissue disorder
• Cognitively impaired or unable/unwilling to comply with follow-up
• Past history of vertebroplasty or kyphoplasty of the thoracic or lumbar spine

Related Conditions & MeSH terms

• Scoliosis

Intervention

Device:
• Active Bodysuits
The wear trial period will be 9-12 months for each subject depending on the active biofeedback training progress. The bodysuits should provide active biofeedback training to the users. By incorporating the IMU sensors, the body alignment in the sagittal or coronal planes can be detected to provide feedback to the users via a wireless platform. This training will be customized to each individual user and will achieve a uniform body alignment goal that benefits the user. The participants will be assessed using the Scoliosis Research Society questionnaire (SRS-22r), the Oswestry Disability Index (ODI) and health-related quality-of-life (HRQOL) measures.

Locations

Country	Name	City	State
Hong Kong	Duchess of Kent Children's Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body alignment	Evaluation of kyphosis or lordosis in the sagittal plane	9-12 months
Secondary	Scoliosis Research Society Quality of Life Questionnaire	Scoliosis specific quality of life measure	1 year
Secondary	Oswestry Disability Index	Back disability quality of life measure	1 year