In the current study a prototype will be evaluated in a lab-based setting. This in order to provide information for the development of the ROBERT-SAS combination.
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome parameter the success rate of intention detection, expressed
as the % of times the electrostimulation is reached across all repetitions.
Secondary outcome
Secondary outcome values are: position, force, FES amplitude, trajectory
completion rate (per stage 1-3), timing and velocity parameters and muscle
activity. From the position data the joint angles will be derived, the force is
measured with a build in force sensor and the muscle activity with sEMG
electrodes.
Background summary
Stroke is one of the leading causes of disability of adults in the European
Union. Around 80% of stroke survivors experience deficits in motor control,
resulting in problems with keeping balance and walking, for instance. The
extent and amount of deficits differ per individual. Interventions to train the
lower extremity almost always consist of walking exercises. However, patients
in the acute phase or with severely affected lower extremity function are often
unable to walk or to walk independently. Therefore the combination of a robot
(ROBERT) and functional electrical stimulation (FES) is developed to provide a
rehabilitation at bedside.
Study objective
In the current study a prototype will be evaluated in a lab-based setting. This
in order to provide information for the development of the ROBERT-SAS
combination.
Study design
The current study is a cross-sectional observational study.
Study burden and risks
The current study consists of at least one visit and maximal five visits to the
lab of Roessingh Research and Development. The robot, ROBERT is CE-certified.
However, the combination ROBERT-SAS, combining both FES and robot support, is
not, although previous tests have shown this approach is possible and tolerable
by healthy persons. There is no direct advantage for the participants, but the
risks are regarded as minimal because he study load is relatively low, without
invasive procedures, with room for rest in between trial sets as required by
the participant, and application of individual stimulation profiles to not
exceed tolerance levels or inflict pain during electrostimulation.
Roessinghbleekweg 33b
Enschede 7522AH
NL
Roessinghbleekweg 33b
Enschede 7522AH
NL
Listed location countries
Age
Inclusion criteria
• Sub(acute) stroke
• Above 18 years
• Able to provide informed consent
• Unilateral ischemic or haemorrhagic stroke
• Hemiparetic lower extremity
Exclusion criteria
• Premorbid disability of lower extremity
• Progressive neurological diseases like, dementia or Parkinson
• Severe cognitive impairment, unable to follow simple instructions and unable
to understand Dutch.
• Skin lesions at the hemiparetic leg
• Contraindication for mobilization like lower limb fracture
• Pacemaker
• Pregnancy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL76919.091.21 |
| OMON | NL-OMON22211 |