The ojective of the study is to answer the quenstion which of the following interventions is most effective in the treatment of children with a severe elbow flexion contracture with Neonatal Brachial Plexus Injury : static serial softcasting or…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
goniometrics in praxis and blinded goniometrics by measuring at a photo
constructed by a blinded therapist.
Secondary outcome
Goal Attainment Scaling with functional goals.
Background summary
The Elbow's flexion contractures in children with Neonatal Brachial Plexus
Injury (NBPI) frequently occur. Treatment additively to stretching is required
when there is progression of the contracture, a contracture of > 30 degrees, or
recurrence after treatment.
Study objective
The ojective of the study is to answer the quenstion which of the following
interventions is most effective in the treatment of children with a severe
elbow flexion contracture with Neonatal Brachial Plexus Injury : static serial
softcasting or treatment with the dynamic elbow orthesis?
Study design
prospective randomized single blinded study
Intervention
This study compares two usually applied inerventions. Intervention 1 concerns
circular serial casting lasting 4 to 6 weeks with change of casts weekly. After
serial casting a removable dorsal splint is used during the night. Intervention
2 concerns a dynamic orthosis with polypropyleen dorsal scales and an extension
Utraflex hinge. This orthosis is used during every night for one year.
Study burden and risks
None
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
1. Diagnosis NBPI
2. Age 2-18 y
3. Additive treatment indication.
Exclusion criteria
1. Insufficient parents' or child's capacity to understand the instructions regarding the use of the orthosis.
2. Insuffitient motivation.
3 A known caput radii dislocation.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL43722.058.13 |