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Trial record 2 of 150 for:    ADULT SCOLIOSIS

The Effect Spinal Bracing System on Gait in Adult Scoliosis Patients

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ClinicalTrials.gov Identifier: NCT03572855
Recruitment Status : Enrolling by invitation
First Posted : June 28, 2018
Last Update Posted : August 8, 2018
Sponsor:
Collaborator:
Aspen Medical Products
Information provided by (Responsible Party):
Texas Back Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Scoliosis Combination Product: Scoliosis Brace Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Peak Scoliosis Spinal Bracing System on Gait and Pain Level in Adult Scoliosis Patients
Actual Study Start Date : June 15, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Arm Intervention/treatment
Experimental: Scoliosis Brace
The Peak Scoliosis Brace designed to alleviate pain in adult patients with chronic pain secondary to scoliosis.
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.




Primary Outcome Measures :
  1. Kinematic Variables Change assessed with human motion capture system [ Time Frame: Baseline; 45 minutes and 2 moths after bracing ]
    3-Dimensional Range of Motion (ROM) during the stance and swing phase of the spine, pelvis, hip, knee, ankle, shoulder, and elbow joint angles along with center of mass and head sway and displacement


Secondary Outcome Measures :
  1. Spatio-Temporal Variables Change assessed with human motion capture system [ Time Frame: Baseline; 45 minutes and 2 moths after bracing ]
    Walking speed

  2. Patient Self-Reported Outcome Assessments Change - Visual analog scale (VAS) [ Time Frame: Baseline; 45 minutes and 2 moths after bracing ]
    VAS for lower back pain, neck and arm pain, and leg pain. Scale range from 0 (no pain) - 10 (most pain)

  3. Patient Self-Reported Outcome Assessments Change - Oswestry Disability Index (ODI, version 2.1.a). [ Time Frame: Baseline; 45 minutes and 2 moths after bracing ]
    Scale range from 0 (no pain) - 10 (most pain)

  4. Patient Self-Reported Outcome Assessments Change - Scoliosis Research Society (SRS22) [ Time Frame: Baseline; 45 minutes and 2 moths after bracing ]
    The SRS-22 Patient Questionnaire has become the most widely used patient-reported outcome instrument in the clinical evaluation of patients with idiopathic scoliosis.

  5. Patient Self-Reported Outcome Assessments Change - Tampa Scale for Kinesiophobia (TSK). [ Time Frame: Baseline; 45 minutes and 2 moths after bracing ]
    TSK is a 17 item questionnaire used to assess the subjective rating of kinesiophobia or fear of movement.

  6. Patient Self-Reported Outcome Assessments Change - Fear Avoidance Beliefs Questionnaire (FABQ) [ Time Frame: Baseline; 45 minutes and 2 moths after bracing ]
    The Fear-Avoidance Beliefs Questionnaire (FABQ) is a patient reported questionnaire which specifically focuses on how a patient's fear avoidance beliefs about physical activity and work may affect and contribute to their low back pain and resulting disability



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 30- 75 years and older
  2. Clinically diagnosed thoracolumbar and/or lumbo-sacro-pelvic deformity as defined by the SRS/Schwab classification systems as Cobb angle of 25° or greater
  3. Able to ambulate without assistance and stand without assistance with their eyes open for a minimum of 10 seconds
  4. Able and willing to attend and perform the activities described in the informed consent within the boundaries of the timelines set forth for pre-, and post-treatment follow-up

Exclusion Criteria:

  1. History of prior attempt at fusion (successful or not) at the indicated levels, (history of one level fusion is not an exclusion)
  2. Major lower extremity surgery or previous injury that may affect gait (a successful total joint replacement is not an exclusion)
  3. BMI higher than 35
  4. Neurological disorder, diabetic neuropathy or other disease that impairs the patient's ability to ambulate or stand without assistance
  5. Major trauma to the pelvis
  6. Pregnant or wishing to become pregnant during the study

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): NCT03572855


Locations
United States, Texas
Texas Back Institute
Plano, Texas, United States, 75093
Sponsors and Collaborators
Texas Back Institute
Aspen Medical Products
Investigators
Principal Investigator: Ram Haddas, PhD Texas Back Institute

Publications:
Arima H, Yamato Y, Hasegawa T, et al. Gait analysis after corrective surgery for adult spinal deformity - good sagittal balance with improved lumber lordosis is important. Scoliosis 2015;10:O76
Marcotte L. SpineCor in the treatment of adult. Scoliosis 2010;5:47.
Portney LG, Watkins MP. Foundation of clinical research: applications to practice. 3rd ed. Upper Saddle River, New Jersy: Julie Levin Alexander, 2009.
Vaughan CL, Davis BL, O'Conner JC. Dynamics of Human Gait. 2nd ed. Cape Town, South Africa: Kiboho Publishers, 1999.

Responsible Party: Texas Back Institute
ClinicalTrials.gov Identifier: NCT03572855     History of Changes
Other Study ID Numbers: TBIRF-Aspen
First Posted: June 28, 2018    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases