Clinical trial NCT01658111: Robot-aided Therapy in Stroke Patients for Upper Limb Rehabilitation
Official title: Robot-aided Therapy in Acute Stroke Patients for the Upper Limb Rehabilitation With Long-term Follow-up.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Robots
EEG
EMG
Lead sponsor: IRCCS San Raffaele Roma
Sponsor class: OTHER
First posted: 2012-08-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Numerous studies showed that ascertaining the effectiveness of rehabilitative interventions on conditions leading to long-term disability, such as stroke, is a complex task because the outcome depends on many interacting factors. Several studies underline the importance of brain plasticity and its therapeutic potential in neurological disorders. Accredited theories of cortical reorganization after brain lesion endorse the use of early, intensive, repetitive, and context-related exercise as optimal strategies to promote motor relearning and minimize motor deficit. The use of robotic systems in upper limb motor rehabilitation programs has been already demonstrated to provide safe and intensive treatment to subjects with motor impairments due to a neurological injury: several studies showed the advantages of robotic therapy on chronic post-stroke patients, even if no consistent influence on functional abilities was found and evidence of better results providing intensive treatments, both robotic and conventional rehabilitative techniques, was found. Recent development and recent trial in robot-assisted rehabilitation has shown the great potential of robotic devices for delivering repetitive training, thus facilitating a high intensity and a large dose of training during sub-acute and chronic phases of stroke rehabilitation. The proposed project, through a randomized controlled observer-blind multicenter trial is aimed at evaluating the effectiveness of robot-assisted therapy as additional treatment to the standard physical therapy in the early phase after stroke onset and evaluating in conjunction with EEG and EMG recordings the effects of the rehabilitative treatments in a quantitative, measurable way, by providing reliable and objective methods for measuring functional recovery after stroke.

Detailed description: The main original contribution of this project is to provide an experimental framework, based on proximal robotic treatment approach, to test whether starting with the distal robot-assisted sensorimotor therapy the effective in improving motor functions of sub-acute stroke patients.

The use of robotic platforms to administer the rehabilitation therapy is crucial for two main reasons:

1. the physical therapies based on robotic platforms assure that each patient in the same testing group is treated in the same repeatable way, eliminating the intrinsic subject-dependent variability that affects traditional therapies;
2. the robotic platforms, in conjunction with EEG and EMG recordings, can be used to assess the effects of the rehabilitative treatments in a quantitative, measurable way, by providing reliable and objective methods for measuring functional recovery after stroke.

Eligibility criteria: Inclusion Criteria:

* first acute event of cerebrovascular stroke
* unilateral paresis,
* ability to understand and follow simple instructions,
* ability to remain in a sitting posture, even through seat belts for trunk fixation.

Exclusion Criteria:

* bilateral impairment,
* severe sensory deficits in the paretic upper limb,
* cognitive impairment or behavioral dysfunction that would influence the ability to comprehend or perform the experiment,
* refusal or inability to provide informed consent
* other current severe medical problems.

Primary outcomes:
measure: Change from Baseline in Fugl-Meyer Scale at 28 weeks.
timeFrame: at inclusion, week 4 and week 28
measure: Change from Baseline in Box and Block Test at 28 weeks.
timeFrame: at inclusion, week 4 and week 28.
Secondary outcomes:
measure: Change from Baseline in Modified Ashworth Scale at 28 weeks.
timeFrame: at inclusion, week 4 and week 28.
Other outcomes:
measure: Change from Baseline in Frenchay Arm Test at 28 weeks.
timeFrame: at inclusion, week 4 and week 28.
Locations:
city: Roma
country: Italy
facility: IRCCS San Raffaele Roma
city: Volterra
country: Italy
facility: Auxilium Viate Volterra
Study officials:
affiliation: IRCCS San Raffaele Rome
name: Michela Goffredo, BME
role: PRINCIPAL_INVESTIGATOR
References: