MedPath

Active Bodysuits for Adult Degenerative Scoliosis

Not Applicable
Conditions
Scoliosis
Interventions
Device: Active Bodysuits
Registration Number
NCT04509310
Lead Sponsor
The University of Hong Kong
Brief 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.

Detailed 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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
15
Inclusion Criteria
  • Adults diagnosed with degenerative scoliosis
  • Cobb's angle greater than 25 degrees
  • Chronic lower back pain
  • Limited mobility due to degenerative scoliosis
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Active BodysuitsActive BodysuitsThe 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.
Primary Outcome Measures
NameTimeMethod
Body alignment9-12 months

Evaluation of kyphosis or lordosis in the sagittal plane

Secondary Outcome Measures
NameTimeMethod
Scoliosis Research Society Quality of Life Questionnaire1 year

Scoliosis specific quality of life measure

Oswestry Disability Index1 year

Back disability quality of life measure

Trial Locations

Locations (1)

Duchess of Kent Children's Hospital

🇭🇰

Hong Kong, Hong Kong

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