The purpose of this study is to compare the effect of arm support therapy with conventional therapy, directed at arm function in stroke patients in the sub-acute phase, with regard to both motor aspects and user experiences.
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Before and after training changes in overall arm function (Fugl-Meyer
assessment, Stroke Upper Limb Capacity Scale) and work area are quantified.
Secondary outcome
Also, user experience of therapist and patient (semi-structured interviews) are
identified after training. Both before and after training a Visual Analog Scale
for pain is filled in by patients.
Background summary
After a stroke, many patients suffer from an impaired motor task performance of
the upper extremity. Optimal restoration of arm and hand function is important
for stroke patients to independently perform activities of daily living. To
stimulate restoration of arm function after stroke, intensive and task-specific
training is essential. To implement this, the application of robotic devices in
rehabilitation is promising. Especially, active movements may be facilitated by
the application of arm support. One of the biggest advantages of arm support
using a robotic device is currently the possibility to 'automate' treatment (a
therapist can treat multiple patients simultaneously) so that the productivity
of health care can be increased and the costs can be reduced. Contemporary
research on this has focused on patients in the chronic phase after stroke.
However, it is likely that especially patients in the sub-acute phase after
stroke benefit from this application, since recovery processes can be
stimulated directly.
Study objective
The purpose of this study is to compare the effect of arm support therapy with
conventional therapy, directed at arm function in stroke patients in the
sub-acute phase, with regard to both motor aspects and user experiences.
Study design
Multicenter, randomized intervention study with evaluation measurements before
and after 6 weeks of reach training.
Intervention
The participants receive reach training for the affected arm during 6 weeks, 3
times 30 minutes per week. The intervention group (35 persons) will train using
the ArmeoBoom system for arm support and the control group (35 persons) will
perform standardized reaching exercises, with similar training intensity.
Study burden and risks
The risks for the participants are limited to a minimum, since the movement
tasks consist of functional and familiar arm movements, all executed within the
ability of the person. Furthermore, the measurements in this study are
relatively simple (no special equipment required) and non-invasive and pose no
risk or inconvenience for the participants.
Participation in this study may present an immediate benefit for the
participant, in the sense that additional training of reaching of the affected
arm is received.
Roessingsbleekweg 33b
7522 AH Enschede
NL
Roessingsbleekweg 33b
7522 AH Enschede
NL
Listed location countries
Age
Inclusion criteria
- Start of participation between 1 and 12 weeks post first-ever stroke
- Hemiparetic arm, with ability of some elbow extension (MRC score 2 or 3 out of 5)
- Ability to understand and follow instructions
- Ability to endure training and evaluation sessions
Exclusion criteria
- Co-morbidity of other diseases (incl. pain) that limit use of the arm
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 | NL33365.044.10 |
| Other | TC 2539 |
| OMON | NL-OMON26063 |