Stroke
Conditions
Brief summary
Neurological patients (e.g., after stroke) need long-term neurorehabilitation therapy of the arm with often limited, unsatisfactory outcome. Robots became a promising supplement or even alternative for neurorehabilitation training.
Detailed description
The exoskeleton robot ARMin was further developed and software components adapted accordingly to offer a unique intensified and patient-tailored robot-aided training of the arm. The goal is to enhance treatment efficacy to an extent that the improvement in motor function is meaningful for the individual patient. The study objective is to compare ARMin therapy and a form of conventional occupational therapy that involves both arms regarding change in motor function.
Interventions
DEVICEARMin
arm therapy robot
OTHEROccupational Therapy
bilateral arm training
Sponsors
Rehaklinik Zihlschlacht AG
Swiss Federal Institute of Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Lots will be drawn that assign to either robotic therapy or occupational therapy
Intervention model description
randomized
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \- Aged ≥18 years * Ischemic cerebral vascular accident (CVA, stroke) in the sub-acute phase (one to twelve weeks post-stroke) as verified by brain imaging (CT or MRI) * Inpatient at Rehaklinik Zihlschlacht, Switzerland * Decreased arm motor function in one arm with a FMA of 8 to 20 points (out of 66) * No excessive spasticity of the affected arm (modified Ashworth Scale mAS ≤3) as assessed by the physician * No serious medical or psychiatric disorder as assessed by the physician * No serious orthopaedic, rheumatologic or other disease restricting movements of the paretic arm as assessed by the physician * No clinically significant shoulder subluxation (palpation \<2 fingers) as assessed by the physician * No skin ulcerations at the paretic arm as assessed by the physician * Ability to communicate effectively with the examiner such that the validity of the patient's data could not be compromised as assessed by the physician * No history of cyber sickness (e.g., nausea when looking at a screen or playing computer games) as assessed by the physician * No pacemaker or other implanted electric device as verified by patient record * Bodyweight \<120 kg * No serious cognitive defects or aphasia preventing effective use of ARMin as assessed by the physician
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl Meyer Assessment, upper extremity motor function | from baseline to day 3 post-training | impairment based clinical test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ARMin assessment torques | from baseline to day 3 post-training | torques |
| ARMin assessment positions | from baseline to day 3 post-training | positions |
| ARMin assessment time | from baseline to day 3 post-training | time |
| Motor Activity Log | from baseline to day 3 post-training | questionnaire |
| handheld dynamometer | from baseline to day 3 post-training | isometric strength |
| Intrinsic Motivation Inventory | from baseline to day 3 post-training | questionnaire |
Countries
Switzerland
Outcome results
None listed