Active Bodysuits for Adult Degenerative Scoliosis

Effectiveness of Active Bodysuits for Adult Degenerative Scoliosis

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.

Study Overview

• Status: Recruiting
• Conditions: Scoliosis
• Intervention / Treatment: Device: Active Bodysuits

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.

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Duchess of Kent Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Active Bodysuits; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body alignment	Evaluation of kyphosis or lordosis in the sagittal plane	9-12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scoliosis Research Society Quality of Life Questionnaire	Scoliosis specific quality of life measure	1 year
Oswestry Disability Index	Back disability quality of life measure	1 year

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 6, 2019
• Primary Completion (ANTICIPATED): June 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: June 5, 2020
• First Submitted That Met QC Criteria: August 10, 2020
• First Posted (ACTUAL): August 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 5, 2021
• Last Update Submitted That Met QC Criteria: October 2, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Active Bodysuits
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: UW19-026

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No