Active Bodysuits for Adult Degenerative Scoliosis

NCT04509310 | Unknown

• 1 other identifier: UW19-026
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Scoliosis

Keywords

Active Bodysuits

Outcome Measures

Primary Outcomes (1)

• Body alignment

  Evaluation of kyphosis or lordosis in the sagittal plane

  9-12 months

Secondary Outcomes (2)

• Scoliosis Research Society Quality of Life Questionnaire

  1 year

• Oswestry Disability Index

  1 year

Study Arms (1)

Active Bodysuits

EXPERIMENTAL

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.

Device: Active Bodysuits

Interventions

Active Bodysuits DEVICE

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.

Active Bodysuits

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead
• The Hong Kong Polytechnic University: collaborator

Study Sites (1)

Duchess of Kent Children's Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Dr Kenny Kwan, BMBCh (Oxon)

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Kenny Kwan, BMBCh (Oxon)

CONTACT

+852 22554654; kyhkwan@hku.hk

Ms Amy Cheung, MA

CONTACT

+852 22554654; amycheung114@ortho.hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: August 12, 2020
• Study Start: January 6, 2019
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 5, 2021

Record last verified: 2021-09

Locations

HK (1)