The goal of this study is to test the effectiveness of using the ArmAssist and Antari Homecare platform at home on upper extremity function in chronic stroke patients.Secundairy objectives are:- To evaluate the user-friendliness of the ArmAssist and…
ID
Source
Brief title
Condition
- Muscle disorders
- Central nervous system vascular disorders
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study outcome is the Wolf Motor Function Test (WMFT). This wil be
tested six weeks before the intervention (T0), just before the start of the
intervention (T1) and after the six weeks of intervention (T2). To examine the
retention, these tests will be performed again six weeks after the end of the
intervention (T3) and after 6 months (T4).
Secondary outcome
Secondary outcomes are the Action Research Arm Test (ARAT), Fugl-Meyer
Assessment-Upper Extermity (FMA-UE), Intrinsic Motivation Inventory (IMI),
System Usability Scale (SUS), Dutch Quebec User Evaluation of Satisfaction with
Assistive Technology (D-QUEST) and EuroQol-5D (EQ-5D) and biomechanical data
using the ArmAssist Assessment (AAA). Subjective opinion will be assessed
during in-depth interviews.
Background summary
Some stroke survivors are able to (partially) recover if proper rehabilitation
therapy is followed regularly. The key principle in rehabilitation training is
repeating task-specific movements to stimulate motor learning. More training
has shown to be associated with better motor recovery. Since the number of
patients with chronic stroke is increasing and the resources to treat all these
patients are limited, the focus of rehabilitation shifts from rehabilitation
centers to training at home using robotic tools. The effectiveness of robotic
therapy has been proven. The upper extremity (UE) is rarely tackled. In this
project we will evaluate hoMEcare aRm rehabiLItatioN (MERLIN). MERLIN will
provide an easy to use and affordable device to assist and stimulate arm
function (ArmAssist) which is coupled to the Antari Homecare platform (*GMV*).
The home training with ArmAssist provides the possibility for patients to train
daily with the (remote) supervision of the therapist via the Antari Homecare
platform, which is often not possible in rehabilitation centers. We hypothesize
that patients will recover more from training with the ArmAssist than from
conventional treatment and therefore the arm/hand function will improve.
Study objective
The goal of this study is to test the effectiveness of using the ArmAssist and
Antari Homecare platform at home on upper extremity function in chronic stroke
patients.
Secundairy objectives are:
- To evaluate the user-friendliness of the ArmAssist and Antari Homecare
platform.
- To evaluate the change in biomechanical variables such as position and its
derivatives, grasp force and range of pro-supination before and after the
training period using the ArmAssistAssessment.
- To evaluate the subjective opinion of the patient about the system*s
usability and effectiveness
Study design
Repeated measures within subject design.
A schematic overview of the measurement:
T0 = week 1: More additional information about the study can be provided and
questions can be asked about the study procedures. The function of the arm/hand
are tested, during one of the measurements a video is made of the participant
to be able to assess the movement afterward. Furthermore a questionnaire about
the quality of life and more personal information about the patient is
gathered.
T1 = week 7: The function of the arm/hand are tested, during one of the tests,
motion capture is used and video is made to assess the movement afterward. A
questionnaire about the quality of life is assessed. Information about the
ArmAssist is provided and explained. The device will be customed to fit the
patient. The ArmAssistAssessment will be done.
Trainingsperiod of 6 weeks: once every 2 weeks the investigator will visit the
patient to calibrate the system, this will keep the games challenging (±30
min). The patient will train minimal 3 hours per week. He/she can divide this
over 4 to 7 trainings sessions. At least 24 hours should be between two
consecutive training sessions.
T2 = week 13: The function of the arm/hand are tested, during one of the tests,
motion capture is used and video is made to assess the movement afterward.
Questionnaires about the quality of life and the opinion of the patient about
training with the ArmAssist are assessed. A depth-interview will be held with
the patient about the subjective experience and opinion of the patient with
regard to training at home with the ArmAssist.
T3 = week 19: The function of the arm/hand are tested, during one of the tests
a video is made of the participant to be able to assess the movement afterward.
Furthermore a questionnaire about the quality of life is assessed.
T4 = week 45: The function of the arm/hand are tested, during one of the tests
a video is made of the participant to be able to assess the movement afterward.
Furthermore a questionnaire about the quality of life is assessed.
Intervention
The intervention consists of training for six weeks with Merlin for minimal 3
hours per week divided over minimally 4 to maximal 7 sessions. The time between
training session should be at least 24 hours. The content of the training is:
playing serious games which are controlled by the arm in the ArmAssist.
Study burden and risks
The patient will have to perform multiple performance tests and questionnaires,
these will take approximately 2 hours to complete and have to be executed 5
times over a period of 9 months. Patients have the option to perform these
tests at home or in the hospital/rehabilitation center. The patient is asked to
train with the device for six weeks, this will have impact on his/her week
schedule. The risk on pain due to overtraining is low since the minimal amount
of training hours for training effects is used and only one training per 24
hours can be done. The collection of data from the ArmAssist will also be an
objective assessment of the progress of the patient which may help during
decision making. In previous studies it was demonstrated that the ArmAssist was
safe to be used for training, no (serious) adverse effects were reported.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
unilateral paresis, first incidence of stroke, minimal 6 months, maximum 3
years post stroke, Fugl-Meyer Assessment-Upper extremity score below 50, able
to perform 3 times finger extension and have some proximal voluntary movement
capability, ability to give informed consent, visual and cognitive ability to
participate in the protocol, understand dutch or english language, know how to
operate a computer (of someone to help)
Exclusion criteria
(Self-reported) depression, other rheumatologic, orthopaedic or neurological
disorders,
following occupational or physiotherapy specifically focussed on the arm/hand
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 | NL69064.042.19 |
| Other | NL7535 |