Skip to content

Aspects of bracing in adolescent idiopathic scoliosis

The Maastricht brace in the treatment of Adolescent Idiopathic Scoliosis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON23817
Enrollment
20
Registered
2015-05-09
Start date
2018-03-12
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Adolescent idiopathic scoliosis

Interventions

Sponsors

None (pending)
Lead Sponsor

Eligibility

Age
12 Years to 17 Years

Inclusion criteria

Inclusion criteria: 1. AIS 2. Indication for conservative treatment 3. Age above 12 years old 4. Eligible for follow up 5. Ability to read and write in the Dutch language 6. Patient who are physically and mentally willing and able to comply with the functional evaluation

Exclusion criteria

Exclusion criteria: 1. Prior surgery to the spine 2. Morbid obesity (BMI>35) 3. Any musculoskeletal or neurological (congenital) disorder 4. Patients who are unwilling to cooperate with the study protocol and follow-up schedule.

Design outcomes

Primary

MeasureTime frame
The main objective of the study is to quantify the effect of conservative treatment of AIS with the use of the new developed Maastricht brace (ABR 09-02-029) by determining the deformation of cobb’s angle over time, using longitudinal radiological assessment with use of anteroposterior and lateral full spine radiographs.

Secondary

MeasureTime frame
Secondary Objectives: • Compliance in brace treatment for AIS Using an incorporated thermo sensor in the brace to objectify actual brace wearing by the patients. • Pulmonary function in thoracolumbar brace Brace wear should result in changes in pulmonary function, predictable in nature. Pulmonary function at end point of brace wear comparable to healthy subject. (compared to non-brace wear) • Pressure measurements in brace Is the brace able to apply the requested amount of force • Motion analysis in brace (VICON) Is the brace allowing the patient to demonstrate a normal walking pattern compared to healthy subjects

Contacts

Public ContactD.E. Schrander

MUMC+

dirkschrander@gmail.com

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)