Clinical trial NCT02321254: Myoelectric Robot-assisted Rehabilitation for the Upper Limb After Stroke
Official title: A Pilot Study of Active, Robot-assisted Therapy for Shoulder Rehabilitation After Stroke, Using Myoelectric Signals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stroke
Keywords: Stroke
Upper limb
Robotics
Electromyography
Rehabilitation
Lead sponsor: IRCCS San Camillo, Venezia, Italy
Sponsor class: OTHER
Collaborators: name: FerRobotics Compliant Robot GmbH, Linz, Austria
First posted: 2014-12-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Fugl-Meyer Assessment scale - Upper Extremity (FMA-UE)
timeFrame: 3 weeks (15 sessions)
Secondary outcomes:
measure: Functional Independence Measure (FIM)
timeFrame: 3 weeks (15 sessions)
measure: Reaching Performance Scale (RPS)
timeFrame: 3 weeks (15 sessions)
measure: Modified Ashworth Scale (MAS) of five muscles
timeFrame: 3 weeks (15 sessions)
measure: Nine Hole Pegboard Test (NHPT)
timeFrame: 3 weeks (15 sessions)
Other outcomes:
measure: Shoulder active range of movement (ROM-S)
timeFrame: 3 weeks (15 sessions)
measure: • Average amount of active task repetitions of a sequence of motor tasks using the robot during a 1-hour therapy treatment.
timeFrame: 3 weeks (15 sessions)
measure: • 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 .
timeFrame: 3 weeks (15 sessions)
measure: • 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.
timeFrame: 3 weeks (15 sessions)
measure: • 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
timeFrame: 3 weeks (15 sessions)
Locations:
city: Linz
country: Austria
facility: FerRobotics Compliant Robot Technology GmbH
city: Venice
country: Italy
facility: IRCCS San Camillo Hospital Foundation
Study officials:
affiliation: IRCCS San Camillo Hospital Foundation, Venice (Italy)
name: Andrea Turolla, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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