The objectives of this study are to gain more insight in the efficacy of splinting therapy for correction of the anatomy and answering the followig questions:1.What are the effects of conservative splinting therapy in children with congenital hand…
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Function (Mobility,Strength,Sensibility,Pain,Handfunction,Stability,Anatomy)
Esthetics
Qualityof life
Activity level
Participation level
Secondary outcome
none
Background summary
Children, parents and doctors need to make important decisions in very young
children about specific treatments such as splinting therapy and surgery. These
therapies primarily aim at function and esthetics. It is of great importance
for decision making to increase to insight into the effects of interventions.
By improving our knowledge about longterm effects at all relevant levels,
indication for therapy will be more clear. The medical team as well as the
children and their parents need more insight into the implications of the
choices that can be made.
As far as we know in this population, this intervention has not been
investigated.
Study objective
The objectives of this study are to gain more insight in the efficacy of
splinting therapy for correction of the anatomy and answering the followig
questions:
1.What are the effects of conservative splinting therapy in children with
congenital hand anomalies?
1. What are the effects of splinting therapy in children with congenital hand
deformities?
2. What is the optimal duration of splinting therapy
Study design
All children with congenital hand deformities that will receive conservative
splinting therapy, will be included. Included children will be measured before
therapy, and 3 , 6 12, 24, 36, 48 months after intervention. Measurements
during and after intervention will be combined with an appointments at the
outpatient clinic. Children undergoing more therapies will be measured every 3
and 6 months after therapy.
Patiënts will have to fill out 3 questionnaires concerning function in daily
life and development. The hand will be tested on several aspects, such as range
of motion and strength. The questionnaires only need to be filled out at
pre-therapy and after therapy at 12, 24 and 36, 48 months.
Intervention
The intervention consists of a custommade thermoplastic splint made by a
hantherapsits and has to be worn during the night.
Study burden and risks
Burden: measurement will be performed during normal visits at the hand therapy
department for revision of the splint. Approximately 45 minutes extra time will
be needed
Risk: There is no risk for the patients of participating in this study
's Gravendijkwal 230
3015 CE
NL
's Gravendijkwal 230
3015 CE
NL
Listed location countries
Age
Inclusion criteria
splinting therapy, congenital hand deformity
Exclusion criteria
age above 13 yrs
Design
Recruitment
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 | NL18101.078.07 |