To determine the inter- and intrarater reliability of 4 different methods to define stump volume in vivo, namely: water displacement method, Omega Tracer (Ohio Willow Wood), Design TT (Otto Bock) and circumference measurement (Sytzia-method).
ID
Source
Brief title
Condition
- Other condition
- Soft tissue therapeutic procedures
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Health condition
Amputatie onderste extremiteit
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Inter- and intrarater reliability.
Secondary outcome
not applicable
Background summary
To determine the effect of a treatment in transtibial amputees often *readiness
for prosthetic fitting* is chosen as outcome variable. One of the criteria of
*readiness for prosthetic fitting* is reaching a stable volume of the stump. To
assess stability of a stump volume, an accurate and reliable assessment is
indispensable. Different methods to measure stumpvolume are used in practice.
Examination into the reliability of these methods is particularly done in
vitro, by using test cilinders. Less or no research at all has been done into
the reliability of these methods in vivo.
Study objective
To determine the inter- and intrarater reliability of 4 different methods to
define stump volume in vivo, namely: water displacement method, Omega Tracer
(Ohio Willow Wood), Design TT (Otto Bock) and circumference measurement
(Sytzia-method).
Study design
A reliability study will be performed. The stump volume of 60 participants will
be measured in two occasions. Each occasion consists of 2 sessions, in each
session 2 observers will do the four measuring methods. The measurements will
be done by two researchers, in which each researcher carries out two
measurements sessions. The sequence of the observers as well as the
measurements within the sessions will be randomized.
Study burden and risks
The participants will come twice to the study location. Travelling expenses
will be compensated. The expected time the measurements will take is
approximately one and a half hours per occasion. The measurements won*t bring
any risk to the participants.
Postbus 30001
9700 RB Groningen
NL
Postbus 30001
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
1: Transtibial amputation
2: More than 12 months post-amputation
3: Informed consent
4: Patient is able to stand safe on one leg
Exclusion criteria
1: Cardiac- or renal diseases resulting in volume fluctuation of the stump
Design
Recruitment
Medical products/devices used
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 | NL14411.042.07 |