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Active Bodysuits for Adult Degenerative Scoliosis

Primary Purpose

Scoliosis

Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Active Bodysuits
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scoliosis focused on measuring Active Bodysuits

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duchess of Kent Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active Bodysuits

Arm 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.

Outcomes

Primary Outcome Measures

Body alignment
Evaluation of kyphosis or lordosis in the sagittal plane

Secondary Outcome Measures

Scoliosis Research Society Quality of Life Questionnaire
Scoliosis specific quality of life measure
Oswestry Disability Index
Back disability quality of life measure

Full Information

First Posted
June 5, 2020
Last Updated
October 2, 2021
Sponsor
The University of Hong Kong
Collaborators
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT04509310
Brief Title
Active Bodysuits for Adult Degenerative Scoliosis
Official Title
Effectiveness of Active Bodysuits for Adult Degenerative Scoliosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 6, 2019 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
Collaborators
The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis
Keywords
Active Bodysuits

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Bodysuits
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Active Bodysuits
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body alignment
Description
Evaluation of kyphosis or lordosis in the sagittal plane
Time Frame
9-12 months
Secondary Outcome Measure Information:
Title
Scoliosis Research Society Quality of Life Questionnaire
Description
Scoliosis specific quality of life measure
Time Frame
1 year
Title
Oswestry Disability Index
Description
Back disability quality of life measure
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Kenny Kwan, BMBCh (Oxon)
Phone
+852 22554654
Email
kyhkwan@hku.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Ms Amy Cheung, MA
Phone
+852 22554654
Email
amycheung114@ortho.hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Kenny Kwan, BMBCh (Oxon)
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duchess of Kent Children's Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Kenny Kwan, BMBCh (Oxon)
Phone
+852 22554654
Email
kyhkwan@hku.hk
First Name & Middle Initial & Last Name & Degree
Ms Amy Cheung, MA
Phone
+852 22554654
Email
amycheung114@ortho.hku.hk
First Name & Middle Initial & Last Name & Degree
Dr Kenny Kwan, BMBCh (Oxon)

12. IPD Sharing Statement

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Active Bodysuits for Adult Degenerative Scoliosis

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