Stroke
Conditions
Keywords
Stroke, Upper limb, Robotics, Electromyography, Rehabilitation
Brief summary
The aim of this study is to assess the clinical effectiveness of the RehaARM-robot and to determine the feasibility of including robotic therapy in daily rehabilitation programmes, after stroke. Additionally, we aim to investigate the acceptance of this intervention from patients and therapists. A total of 10 patients will be recruited in this study, all the patients will receive 1 hour of standard therapy together with 45 min of robot therapy every day. The robot therapy will last 45 minutes, for 15 consecutive days within a maximum period of four weeks. Additional 15 minutes are required for placing surface electrodes on the shoulder and patient preparation. The study will include passive and active shoulder training of four movements: Horizontal abduction/adduction, abduction/adduction, internal/external rotation and flexion/extension. The passive part lasts 10 minutes and the active part 35 minutes.
Interventions
DEVICEThe RehaARM-Robot
Robot therapy by using a 3-Degrees-Of-Freedom (3DOFs) robot to train the shoulder.
BEHAVIORALStandard rehabilitation therapy
Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities.
Sponsors
FerRobotics Compliant Robot GmbH, Linz, Austria
IRCCS San Camillo, Venezia, Italy
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients suffering from stroke, ischemic and / or hemorrhagic * Stroke in the left hemisphere * Score between 1 and 3 in the upper-limb sub-item of the Italian version of the National Institute of Health Stroke Scale (IT-NIHSS) (Pezzella et al. 2009) * Score of the Functional Independence Measure (FIM) scale (Keith et al., 1987) less than 100 out of a total of 126. This scale is used as a reference to indicate the degree of autonomy in carrying out activities of daily living (ADLs) * Score of the upper-limb Fugl-Meyer scale (FMA) (Fugl-Meyer et al., 1975) less than 60. This scale measures the residual motor function of a person after stroke
Exclusion criteria
* Non-stabilized fractures * Diagnosis of depression * Traumatic brain Injury * Pharmacologically uncontrolled epilepsy * Ideomotor apraxia * Neglect * Mini Mental State Examination (MMSE) score \<20/30 * Severe impairment of verbal comprehension, defined by a score in the Token Test (Tau points\<58/78) * Patients participating in other rehabilitation treatments for the upper-limb (e.g. virtual reality treatment, motor imagery, etc)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment scale - Upper Extremity (FMA-UE) | 3 weeks (15 sessions) | Motor function of the upper limb is measured by means of the Upper Extremity Motor Assessment of the Fugl-Meyer Assessment Scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Independence Measure (FIM) | 3 weeks (15 sessions) | FIM is an 18-item scale that assesses patient's disability and medical rehabilitation functional outcome (A total of 126 points). |
| Reaching Performance Scale (RPS) | 3 weeks (15 sessions) | It assesses the ability of subjects to reach an object (a cone). The cone is placed at a 4-cm distance and after at a 30-cm distance from the subject. The subject is asked to reach and grab the cone if possible. The observer evaluates the quality of reaching instead of the grip strength ( A total of 36 points). |
| Modified Ashworth Scale (MAS) of five muscles | 3 weeks (15 sessions) | Spasticity is measured using the MAS of five muscles: Pectoralis major, biceps, wrist flexors, flexor digitorum superficialis, flexor digitorum profundus (Total of 20 points). |
| Nine Hole Pegboard Test (NHPT) | 3 weeks (15 sessions) | It measures the dexterity of the hand. Patient should insert 9 pins in the board. There are 9 pins. The number of pins inserted in 50 min are registered or if the patient inserted 9 pins, then the time is registered. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Shoulder active range of movement (ROM-S) | 3 weeks (15 sessions) | Active range improvement for shoulder abduction and flexion are measured using the Tyromotion Pablo System. |
| • Average amount of active task repetitions of a sequence of motor tasks using the robot during a 1-hour therapy treatment. | 3 weeks (15 sessions) | A higher number of repetitions is a paramount for neuroplasticity. The ability of subjects to execute a larger of number of motor task repetitions with the robot after the treatment is measured. |
| • Smoothness of the torque (i.e. Number of peaks of the torque, [n]) for a sequence of motor tasks using the robot during a 1-hour therapy treatment . | 3 weeks (15 sessions) | Smoothness is a measure of human movement coordination. Improvement of smoothness after the treatment is measured. |
| • Average magnitude of the muscle activation during the active phase normalized by duration of the active phase (magnitude/time) for a sequence of motor tasks using the robot during a 1-hour therapy treatment. | 3 weeks (15 sessions) | — |
| • Average similarity between the muscle (synergy) modules of the paretic arm and the muscle modules of the right arm of healthy subjects for a standard sequence of motor tasks using the robot during a 1-hour therapy treatment | 3 weeks (15 sessions) | — |
Countries
Austria, Italy
Outcome results
None listed