Effect of in- and outpatient brace adaptation protocols on brace compliance in adolescent patients with idiopathic scoliosis

Effect of in- and outpatient brace adaptation protocols on brace compliance in adolescent patients with idiopathic scoliosis - Brace pilot study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON41782

Enrollment

Registered

2015-05-29

Start date

2016-06-26

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

curved spine scoliosis

Interventions

None listed

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: Patients 10 years or older with an idiopathic adolescent scoliosis with an indication for brace treatment who have not had an operative treatment for scoliosis in the past

Exclusion criteria

Exclusion criteria: • Scoliose with the apex of the curve proximal to T7 • A previous brace treatment for scoliosis • A previous surgical treatment for scoliosis • Patients who are not able to fill in the questionaires

Design outcomes

Primary

Measure	Time frame
The primary outcome parameter is short and long term brace compliance as measured by a temperature logger in the brace. The temperature logger will be programmed to store the date time and temperature every 20 minutes. The sensor has been validated in the past in which a temperature between 32.2 and 37.2 indicates that the brace is worn.	—

Secondary

Measure	Time frame
Secondary outcome parameters are welbeiing of the AIS patients as measured by the PedsQL and SRS-22	—

Countries

Netherlands

Outcome results