Clinical trial NCT04509310: Active Bodysuits for Adult Degenerative Scoliosis
Official title: Effectiveness of Active Bodysuits for Adult Degenerative Scoliosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Scoliosis
Keywords: Active Bodysuits
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: The Hong Kong Polytechnic University
First posted: 2020-08-12
Enrollment: 15
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Body alignment
timeFrame: 9-12 months
Secondary outcomes:
measure: Scoliosis Research Society Quality of Life Questionnaire
timeFrame: 1 year
measure: Oswestry Disability Index
timeFrame: 1 year
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Duchess of Kent Children's Hospital
Study officials:
affiliation: The University of Hong Kong
name: Dr Kenny Kwan, BMBCh (Oxon)
role: PRINCIPAL_INVESTIGATOR
References: