Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Active Bodysuits for Adult Degenerative Scoliosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04509310
Recruitment Status : Recruiting
First Posted : August 12, 2020
Last Update Posted : October 5, 2021
Sponsor:
Collaborator:
The Hong Kong Polytechnic University
Information provided by (Responsible Party):
Dr. Kenny Kwan, The University of Hong Kong

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Scoliosis Device: Active Bodysuits Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Active Bodysuits for Adult Degenerative Scoliosis
Actual Study Start Date : January 6, 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Body alignment [ Time Frame: 9-12 months ]
    Evaluation of kyphosis or lordosis in the sagittal plane


Secondary Outcome Measures :
  1. Scoliosis Research Society Quality of Life Questionnaire [ Time Frame: 1 year ]
    Scoliosis specific quality of life measure

  2. Oswestry Disability Index [ Time Frame: 1 year ]
    Back disability quality of life measure


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04509310


Contacts
Layout table for location contacts
Contact: Dr Kenny Kwan, BMBCh (Oxon) +852 22554654 kyhkwan@hku.hk
Contact: Ms Amy Cheung, MA +852 22554654 amycheung114@ortho.hku.hk

Locations
Layout table for location information
Hong Kong
Duchess of Kent Children's Hospital Recruiting
Hong Kong, Hong Kong
Contact: Dr Kenny Kwan, BMBCh (Oxon)    +852 22554654    kyhkwan@hku.hk   
Contact: Ms Amy Cheung, MA    +852 22554654    amycheung114@ortho.hku.hk   
Principal Investigator: Dr Kenny Kwan, BMBCh (Oxon)         
Sponsors and Collaborators
The University of Hong Kong
The Hong Kong Polytechnic University
Investigators
Layout table for investigator information
Principal Investigator: Dr Kenny Kwan, BMBCh (Oxon) The University of Hong Kong
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Dr. Kenny Kwan, Clinical Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT04509310    
Obsolete Identifiers: NCT03332277
Other Study ID Numbers: UW19-026
First Posted: August 12, 2020    Key Record Dates
Last Update Posted: October 5, 2021
Last Verified: September 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Kenny Kwan, The University of Hong Kong:
Active Bodysuits
Additional relevant MeSH terms:
Layout table for MeSH terms
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases