Active Bodysuits for Adult Degenerative Scoliosis

NCT ID: NCT04509310

Last Updated: 2021-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-06

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Scoliosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Active Bodysuits

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hong Kong Polytechnic University

OTHER

Sponsor Role collaborator

The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Dr. Kenny Kwan

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr Kenny Kwan, BMBCh (Oxon)

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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Duchess of Kent Children's Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Dr Kenny Kwan, BMBCh (Oxon)

Role: CONTACT

+852 22554654

Ms Amy Cheung, MA

Role: CONTACT

+852 22554654

Facility Contacts

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Dr Kenny Kwan, BMBCh (Oxon)

Role: primary

+852 22554654

Ms Amy Cheung, MA

Role: backup

+852 22554654

Other Identifiers

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UW19-026

Identifier Type: -

Identifier Source: org_study_id

NCT03332277

Identifier Type: -

Identifier Source: nct_alias

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