The main objective of this study is to find if there is a measurable improvement of transfemoral amputees standing up with the active knee support prosthesis (ERK) in comparison to standing up without active knee support.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Transfemoraal geamputeerden
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter will be: time taken to stand up.
Secondary outcome
Secondary parameters will be: symmetry of Ground Reaction Forces and peak joint
torques for hip and knee of both sides (obtained by inverse dynamics).
Background summary
With 60 stand-up transitions per day, the sit-to-stand movement is a frequently
exercised activity [1]. Standing up involves the entire body and can be more
demanding than other daily routines. It requires significant torque and greater
ranges of joint motion at the knee joint and the ankle joint [2* 6] in
comparison with stair climbing or walking [7*9]. Especially transfemoral
amputees have problems in standing up [11, 12]. One of the most effective ways
to regain mobility is the use of a transfemoral prosthesis [13]. However, for
users of transfemoral prosthesis that lack active stand up mechanisms it proves
difficult to perform stand up transitions independently and they depend on
external assistance [14]. With the help of the new developed active stand up
support knee prosthesis, expected is that amputees can perform easier stand up
transitions.
Study objective
The main objective of this study is to find if there is a measurable
improvement of transfemoral amputees standing up with the active knee support
prosthesis (ERK) in comparison to standing up without active knee support.
Study design
A randomized cross-over-trial study will be conducted at the gait lab of
Erasmus MC. Unilateral transfemoral-amputees will be asked to participate. A
timeframe of nine months is planned to finish this study.
Intervention
To compare standing up with and without active support, 16 subjects will
perform 16 standing up transitions each. Twice at own preferable speed and
twice following the Short Physical
Performance Battery (SPPB) Protocol.
* 3x standing up at own preferable speed with active support.
* 3x standing up at own preferable speed without active support.
* All the exercises following the SPPB protocol.
* 5x standing up following the SPPB protocol with active support
* 5x standing up following the SPPB protocol without active support
Study burden and risks
The measurements will take maximally a half-day per subjects. Subjects do not
benefit from participating in this study. The subject can decide when he/she
needs a break and can decide to drop out of the experiment at any time he/she
wishes. The burden and risks of those measurements seem to be negligible.
Mekelweg 2
Delft 2628 CD
NL
Mekelweg 2
Delft 2628 CD
NL
Listed location countries
Age
Inclusion criteria
Patients who:
- Are age 18 or above
- Have an unilateral transfemoral amputation
- Uses knee prosthesis for at least one year
- Weight less than 100 kg
- Are capable of performing an amount of exercise sessions including 16 stand-up transitions as judges by their primary care physician
Exclusion criteria
Patient who suffer from any balance disorder.
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 | NL62211.078.17 |