The primary objective of the current study is to assess the feasibility of ROBERT® -SAS training in clinical setting, in acute stroke patients, including patient and therapist perspectives
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 is the SUS score from both the patients and the
therapists.
Secondary outcome
In addition to the primary outcome, the surface EMG and resulting force will be
noted with the ROBERT® -SAS system. Furthermore, the selected mode of ROBERT®
-support, SAS parameter settings (including amplitude, frequency and pulse
width of ES) and the treatment settings on the screen will be stored. The
trajectory completion rate will be determined between the different AAN stages.
Exercises specific settings such as repetitions and resistances settings, are
collected. Clinical measurements like the Fugl-Meyer assessment, Motricity
index and forces measured with the MRC test will be recorded over time.
Furthermore, information about the clinical applicability will be gathered.
This information contains information like, the settings that will be used, the
movement that are trained, the time the training and set-up takes (separately
timed) and lastly the training duration (in case of continuing training beyond
3 weeks) and its reasons as reported by therapists (e.g. which aspects were
considered in deciding to prolong the training beyond three weeks).
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 (ES) is being developed to
provide a training tool for early rehabilitation. In the current study a
combination of robot and ES will be evaluated in clinical setting.
Study objective
The primary objective of the current study is to assess the feasibility of
ROBERT® -SAS training in clinical setting, in acute stroke patients, including
patient and therapist perspectives
Study design
The current study is an observational study.
Study burden and risks
The current study consists of several measurement sessions in Roessingh
rehabilitation centre, during the normal rehabilitation time. The robot,
ROBERT® is CE-certified. However, the combination ROBERT® -SAS, combining both
ES and robot support, is not, although previous tests have shown this approach
is possible and tolerable by healthy persons and stroke patients. The risks are
regarded as minimal because it is 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 (< 6 months post-stroke)
• Above 18 years
• Able to provide informed consent
• An ischemic or haemorrhagic stroke
• Hemiparetic lower extremity
Exclusion criteria
• Premorbid disability of lower extremity
• Severe cognitive impairment, unable to follow simple instructions and unable
to understand Dutch.
• Skin lesions at the hemiparetic leg
• Progressive neurological diseases (i.e. Parkinson, dementia, etc.)
• Contraindication for mobilization like lower limb fracture
• Use of pacemaker
• Pregnancy
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 | NL80574.000.22 |