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The Effect Spinal Bracing System on Gait in Adult Scoliosis Patients

NCT03572855 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-08-08

No results posted yet for this study

Summary

Degenerative adult scoliosis (ADS) results from age related changes leading to segmental instability, deformity and stenosis. Patients with scoliosis demonstrate an altered gait pattern.Furthermore, scoliosis patients exert 30% more physical effort than healthy subjects to ensure habitual locomotion, and this additional effort requires a reciprocal increase of oxygen consumption. Bracing has been found to reduce pain within a short time in ADS patients. A new brace has recently become available, the Peak™ Scoliosis Brace (Aspen Medical Products), designed to alleviate pain in adult patients with chronic pain secondary to scoliosis. The purpose of this study is to investigate the impact of spinal bracing using Peak™ Scoliosis Brace on pain and lower extremities kinematics of gait.

Conditions

  • Scoliosis

Interventions

COMBINATION_PRODUCT

Scoliosis Brace

Brace will be fitted to each subject by a spine orthopedic surgeon before the testing. The subject will wear the fitted brace for 2 months.

Sponsors & Collaborators

  • Aspen Medical Products

    collaborator OTHER

  • Texas Back Institute

    lead OTHER

Principal Investigators

  • Ram Haddas, PhD · Texas Back Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-15
Primary Completion
2019-06-30
Completion
2019-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03572855 on ClinicalTrials.gov