The Effect Spinal Bracing System on Gait in Adult Scoliosis Patients

NCT03572855 | Unknown

• 1 other identifier: TBIRF-Aspen
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Scoliosis

Outcome Measures

Primary Outcomes (1)

• Kinematic Variables Change assessed with human motion capture system

  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

  Baseline; 45 minutes and 2 moths after bracing

Secondary Outcomes (6)

• Spatio-Temporal Variables Change assessed with human motion capture system

  Baseline; 45 minutes and 2 moths after bracing

• Patient Self-Reported Outcome Assessments Change - Visual analog scale (VAS)

  Baseline; 45 minutes and 2 moths after bracing

• Patient Self-Reported Outcome Assessments Change - Oswestry Disability Index (ODI, version 2.1.a).

  Baseline; 45 minutes and 2 moths after bracing

• Patient Self-Reported Outcome Assessments Change - Scoliosis Research Society (SRS22)

  Baseline; 45 minutes and 2 moths after bracing

• Patient Self-Reported Outcome Assessments Change - Tampa Scale for Kinesiophobia (TSK).

  Baseline; 45 minutes and 2 moths after bracing

Study Arms (1)

Scoliosis Brace

EXPERIMENTAL

The Peak Scoliosis Brace designed to alleviate pain in adult patients with chronic pain secondary to scoliosis.

Combination Product: Scoliosis Brace

Interventions

Scoliosis Brace COMBINATION_PRODUCT

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.

Scoliosis Brace

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 30- 75 years and older
• Clinically diagnosed thoracolumbar and/or lumbo-sacro-pelvic deformity as defined by the SRS/Schwab classification systems as Cobb angle of 25° or greater
• Able to ambulate without assistance and stand without assistance with their eyes open for a minimum of 10 seconds
• 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

You may not qualify if:

• BMI higher than 35
• Neurological disorder, diabetic neuropathy or other disease that impairs the patient's ability to ambulate or stand without assistance
• Major trauma to the pelvis
• Pregnant or wishing to become pregnant during the study

Sponsors & Collaborators

• Texas Back Institute: lead
• Aspen Medical Products: collaborator

Study Sites (1)

Texas Back Institute

Plano, Texas, 75093, United States

Location

Related Publications (28)

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  BACKGROUND

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  BACKGROUND

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Ram Haddas, PhD

  Texas Back Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: June 28, 2018
• Study Start: June 15, 2018
• Primary Completion: June 1, 2019
• Study Completion: September 1, 2019
• Last Updated: August 8, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)