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Active Bodysuits for Adult Degenerative Scoliosis

Effectiveness of Active Bodysuits for Adult Degenerative Scoliosis

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04509310
Enrollment
15
Registered
2020-08-12
Start date
2019-01-06
Completion date
2022-12-31
Last updated
2021-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scoliosis

Keywords

Active Bodysuits

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.

Interventions

DEVICEActive 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.

Sponsors

The Hong Kong Polytechnic University
CollaboratorOTHER
The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Body alignment9-12 monthsEvaluation of kyphosis or lordosis in the sagittal plane

Secondary

MeasureTime frameDescription
Scoliosis Research Society Quality of Life Questionnaire1 yearScoliosis specific quality of life measure
Oswestry Disability Index1 yearBack disability quality of life measure

Countries

Hong Kong

Contacts

Primary ContactDr Kenny Kwan, BMBCh (Oxon)
kyhkwan@hku.hk+852 22554654
Backup ContactMs Amy Cheung, MA
amycheung114@ortho.hku.hk+852 22554654

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026