Myoelectric Robot-assisted Rehabilitation for the Upper Limb After Stroke (MyoReArm)

IRCCS San Camillo, Venezia, Italy

Status and phase

Completed

Phase 1

Conditions

Stroke

Treatments

Behavioral: Standard rehabilitation therapy

Device: The RehaARM-Robot

Study type

Interventional

Funder types

Other

Identifiers

NCT02321254

Prot.2013.16

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

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)