This study will investigate whether robotic enhanced error training as adjunct to usual care is beneficial for improving arm function in people after stroke.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
cerebrovascair accident
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
This study will assess functional use of the arm by three tests: ARAT, FM and
MAS. Moreover, experience with and appreciation of DeXtreme robotic training
will be evaluated by a custom-made questionnaire.
Secondary outcome
As secondary outcomes, test performance and movement execution will be
evaluated as well as the duration of participants* inpatient rehabilitation.
Background summary
People after stroke often show reduced functional use of their paretic arm.
Despite the development of several treatment methods, full recovery of arm
function is often not achieved in many patients. Therefore, rehabilitation is
in need for new effective methods that can improve functional use of the arm in
people after stroke. Robotic training as adjunct to usual care has shown
promise for improving functional skills in patient groups. This study will
evaluate the effect of a specific robotic device (DeXtreme) on functional use
of the arm in people after stroke. The DeXtreme is a robotic device that helps
to improve arm function by the enhancement of errors, which may stimulate motor
learning processes. It is expected that DeXtreme robotic training with enhanced
errors is beneficial to improve functional use of the arm in people after
stroke. Results of this study will help to decide whether this specific type of
robotic training should be implemented in usual care of the rehabilitation
centre to support both caretakers and people after stroke during
rehabilitation.
Study objective
This study will investigate whether robotic enhanced error training as adjunct
to usual care is beneficial for improving arm function in people after stroke.
Study design
This is a double-blind randomized placebo-controlled study in which treatment
effects will be compared between two experimental groups to assess the effect
of robotic enhanced error training on functional use of the arm and hand in
people after stroke.
Intervention
Participants will perform training sessions on the DeXtreme for two weeks.
Every week, participants will perform three sessions of 20 minutes. This
training is an additive to regular occupational therapy.
Study burden and risks
Participants will perform robotic training three times a week for two weeks,
each training lasting 20 minutes. Robotic training will be performed as adjunct
to their usual care. Functional outcomes will be assessed three times during
the study, twice during their inpatient rehabilitation and once during a
follow-up three months after finishing the study. Participants will fill in a
questionnaire once they have finished their training period. Task performance
and movement execution will be evaluated over the training period. The risk of
participation is negligible, despite of the small risk of developing shoulder
pain. Participants will be monitored closely during the study and the
experimenter will always be present during the training. Participants will need
to invest a maximum of 3 hours in participation, but participation will not
come at cost of regular therapy, as experimental training sessions are
additional to usual care.
Relweg 51
Wijk aan Zee 1949 EC
NL
Relweg 51
Wijk aan Zee 1949 EC
NL
Listed location countries
Age
Inclusion criteria
* Clinical diagnosis of a first stroke, as diagnosed by a neurologist
* Aged 18 years or older
* Unilateral paresis
* Having survived a stroke since at least four weeks ago
* Able to understand simple instructions
* Able to perform partial active movement in the shoulder and elbow and to open
and close the palm of the hand, scoring over 9 points out of 57 in the ARAT
Exclusion criteria
* Multiple strokes
* Severe spasticity or contractures
* Additional orthopaedic problems in the upper limb that affect arm movement
* Significant shoulder pain
* Additional central nervous system illnesses, suffering from apraxia, or
sensory aphasia due to medical amnesia and a neglected side
* Depth perception impairments
* Cognitive or communication disorders leading to inability to follow
instructions
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 | NL76859.029.21 |