Skip to main content
Clinical Trials/NCT04509310
NCT04509310
Unknown
Not Applicable

Effectiveness of Active Bodysuits for Adult Degenerative Scoliosis

The University of Hong Kong1 site in 1 country15 target enrollmentJanuary 6, 2019
ConditionsScoliosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Scoliosis
Sponsor
The University of Hong Kong
Enrollment
15
Locations
1
Primary Endpoint
Body alignment
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 6, 2019
End Date
December 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Kenny Kwan

Clinical Assistant Professor

The University of Hong Kong

Eligibility Criteria

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

Outcomes

Primary Outcomes

Body alignment

Time Frame: 9-12 months

Evaluation of kyphosis or lordosis in the sagittal plane

Secondary Outcomes

  • Scoliosis Research Society Quality of Life Questionnaire(1 year)
  • Oswestry Disability Index(1 year)

Study Sites (1)

Loading locations...

Similar Trials