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Bracing

The Effect Spinal Bracing System on Gait in Adult Scoliosis Patients

N/A
Waitlist Available
Led By Ram Haddas, PhD
Research Sponsored by Texas Back Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; 45 minutes and 2 moths after bracing
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Scoliosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; 45 minutes and 2 moths after bracing
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; 45 minutes and 2 moths after bracing for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Kinematic Variables Change assessed with human motion capture system
Secondary study objectives
Patient Self-Reported Outcome Assessments Change - Fear Avoidance Beliefs Questionnaire (FABQ)
Patient Self-Reported Outcome Assessments Change - Oswestry Disability Index (ODI, version 2.1.a).
Patient Self-Reported Outcome Assessments Change - Scoliosis Research Society (SRS22)
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Scoliosis BraceExperimental Treatment1 Intervention
The Peak Scoliosis Brace designed to alleviate pain in adult patients with chronic pain secondary to scoliosis.

Find a Location

Who is running the clinical trial?

Texas Back InstituteLead Sponsor
7 Previous Clinical Trials
585 Total Patients Enrolled
Aspen Medical ProductsOTHER
6 Previous Clinical Trials
297 Total Patients Enrolled
1 Trials studying Scoliosis
20 Patients Enrolled for Scoliosis
Ram Haddas, PhDPrincipal InvestigatorTexas Back Institute
2 Previous Clinical Trials
200 Total Patients Enrolled
~4 spots leftby Dec 2025