Study Results
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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UNKNOWN
NA
15 participants
INTERVENTIONAL
2019-01-06
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Cobb's angle greater than 25 degrees
* Chronic lower back pain
* Limited mobility due to degenerative scoliosis
Exclusion Criteria
* 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
50 Years
65 Years
ALL
No
Sponsors
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The Hong Kong Polytechnic University
OTHER
The University of Hong Kong
OTHER
Responsible Party
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Dr. Kenny Kwan
Clinical Assistant Professor
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
Countries
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Central Contacts
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Facility Contacts
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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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