Smart Textile Technology for Scoliosis

Scoliosis Clinical Trial

Official title:

Smart Textile Technology for Scoliosis: Aim 1

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02080611
• Other study ID #: 1402M47947
• Status: Withdrawn
• Phase: N/A
• First received: February 28, 2014
• Last updated: November 29, 2017
• Start date: January 2016
• Est. completion date: July 2016

Study information

• Verified date: November 2017
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators hypothesize that a garment-integrated sensing system will be able to detect with clinical accuracy the position of the spine. The investigator will evaluate this using healthy adult volunteers, who will don sensing garments and assume a series of spinal postures. Concurrent with garment sensing, the participant's spine position will be measured using a motion-capture system that uses reflective markers to detect positions of markers in 3D space.

The motion-capture system provides a gold-standard reference measure to which the sensing garments will be compared. Because the investigators are evaluating the accuracy of the sensing garment, it is only necessary that the investigator test the garments on participants with subtly different body shapes. Healthy adult volunteers provide an adequate input to the sensing signal.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy adults

Exclusion Criteria:

• Under age 18 or over age 65

• Any medical condition that impairs movement or makes movement painful or difficult.

Related Conditions & MeSH terms

• Kyphosis
• Scoliosis
• Spinal Deformities

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	Moai Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body movement	The movement and position of participants' spine will be recorded using a motion capture device and using a prototype sensing garment during the 1-2 hour lab test. (This is the only point at which investigators will interact with participants)	Participants will be assessed during a 1-2 hour visit. Visits will be scheduled over a period of approximately one year.