Evaluate the patients experience and progression with robot assisted arm training exercises, and monitor changes over time on arm capacity tests and quality of movements that closely match daily tasks.
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
outcome measures and kinematic measurements as well as experience with the
system and motivational aspects for patients.
Secondary outcome
geen
Background summary
Upper limb robot assisted arm training has been proven an effective addition to
intensive therapy in chronic and subacute stroke patients. So far, effects are
situated at the function, but not activity level of the ICF. In this project, a
robotic system consisting of the haptic master (hardware) and a virtual
learning environment (software) is being tested. This robotic system allows to
individually adjust the level and type of training provided to the level of
impairment and needs of the patient, while features were designed to increase
motivation and participation. It is thought that this may improve training
efficiency.
The progresses made by the patients undergoing robot assisted arm training are
generally monitored via clinical outcome measures, which normally consist of
questionnaires and/or functional tests. However a main disadvantage of these
measurements is that the kinematics of the action is not monitored and thus
scarce information exists on the active range of motion or compensatory
strategies used (function level in ICF). We hypothesize that a series of
robotic exercises that closely match specific activities of daily living can
ultimately provide benefits to stroke subjects. Furthermore we postulate that
using a portable motion capture system we can assess motor progresses more
accurately while at the same time complementing the traditional clinical
assessment.
Study objective
Evaluate the patients experience and progression with robot assisted arm
training exercises, and monitor changes over time on arm capacity tests and
quality of movements that closely match daily tasks.
Study design
8 week intervention study
Intervention
A pilot trial is planned over an 8-week period to evaluate the usability and
training experiences of a robot assisted arm training program in stroke
patients, as well as to obtain a qualitative and quantitative assessment of the
effectiveness of the intervention program.
Study burden and risks
The total duration of the pilot study for a patient is 8 weeks. Robot assisted
arm training will occur over a period of 8 weeks, including 3 (45 minute, 30
minutes of actual therapy) sessions per week leading to a total of 24 sessions.
Clinical evaluation measurements will be taken before the start of the training
(screening at week -1, and baseline at week 0), at 4 weeks at 8 weeks (end of
the intervention) and after 16 weeks follow-up. Subjects will be assessed
using established clinical outcome measures (Fugl-Meyer, ARAT, Motricity index,
Jamar, MAL) and using two questionnaires to assess motivation. At the beginning
(week 0) AND end (week 8) of the intervention, upper limb kinematics during a
prescribed movement protocol will be assessed using a wearable motion capture
system (MMAAS). An evaluation measurement with the training device
(HapticMaster) is planned every week in order to obtain additional objective
data on active arm movements in different directions. The risks associated
with this study do not surpass the risks associated with regular exercise
training methods. The control group will receive the assements, but not the
robotic intervention.
universiteitssingel 50
6200 MD Maastricht
NL
universiteitssingel 50
6200 MD Maastricht
NL
Listed location countries
Age
Inclusion criteria
Volunteers willing to participate
Fully competent in Dutch
Patients who have completed their active clinical rehabilitation program
A clinical definite diagnosis of Stroke (postacute/chronic stroke, Supratentorial)
Upper limb dysfunction due to distinct paresis (Motricity Index (MI) lower than 85/100)
Exclusion criteria
Will-unable
Poor arm function due to muscle weakness (MI <30), not permitting active movements with robotic system
Severe spasticity; MAS score for the elbow and wrist flexors: each >= 3
Severe cognitive or visual deficits interfering with the comprehension or completion of presented virtual tasks.
Severe neglect in the near extra personal space (Menon 2004), established by the letter cancellation test Uttl 2001 and Bell*s test (quantitative evaluation, Gauthier 1989) with a minimum omission score of 15% Ferber(2001)
Broca aphasia, Wernicke aphasia, global aphasia: as determined by Akense Afasie Test (AAT, Graetz, 1987))
Severe apraxia as measured by apraxietest van Heugten (1998)
Design
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| CCMO | NL34284.068.10 |