Robot-aided Therapy in Stroke Patients for Upper Limb Rehabilitation (MITEEG)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by IRCCS San Raffaele
Sponsor:
Information provided by (Responsible Party):
Patrizio Sale , MD, IRCCS San Raffaele
ClinicalTrials.gov Identifier:
NCT01658111
First received: July 24, 2012
Last updated: August 31, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Stroke
Device: Robot Group
Procedure: Traditional physiotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Robot-aided Therapy in Acute Stroke Patients for the Upper Limb Rehabilitation With Long-term Follow-up.

Resource links provided by NLM:


Further study details as provided by IRCCS San Raffaele:

Primary Outcome Measures:
  • Change from Baseline in Fugl-Meyer Scale at 28 weeks. [ Time Frame: at inclusion, week 4 and week 28 ] [ Designated as safety issue: No ]
  • Change from Baseline in Box and Block Test at 28 weeks. [ Time Frame: at inclusion, week 4 and week 28. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in Modified Ashworth Scale at 28 weeks. [ Time Frame: at inclusion, week 4 and week 28. ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change from Baseline in Frenchay Arm Test at 28 weeks. [ Time Frame: at inclusion, week 4 and week 28. ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: July 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Traditional physiotherapy
Each subject will receive 4 weeks of traditional upper limb rehabilitation treatment (20 sessions, 5 days a week for 4 weeks).
Procedure: Traditional physiotherapy
Active or passive exercises.
Other Name: FKT
Experimental: Robot Group
Each subject will be asked to perform five sessions per week goal-directed, planar reaching tasks, which emphasizes shoulder and elbow movements, moving from the centre target to each of 8 peripheral targets equally spaced on a 0.14 m radius circumference around a centre target using the InMotion2 (IM2) system (20 sessions- 5 days a week for 4 weeks).
Device: Robot Group

The MIT-MANUS/InMotion2 (Interactive Motion Technologies, Inc., Watertown, MA, USA) system has two translational degrees of freedom (dof): shoulder abduction-adduction (ab-ad), elbow flexion-extension (flexext).

The robotic system supports the execution of reaching movements in the horizontal plane through an assist as needed control strategy. The robot can guide the movement of the upper limb of the patients and record end-effector physical quantities such as the position, velocity, and applied forces. The device is designed to have a low intrinsic end-point impedance (i.e., be back-drivable to easily carry the weight of the patient's arm, to execute movements without constraint and offer minimal resistance. A 3-dof force transducer is placed at the robots end-effector, as well.

Other Name: MIT-MANUS/InMotion2

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01658111

Contacts
Contact: Patrizio Sale, MD +390652251 patrizio.sale@gmail.com
Contact: Marco Francescini, MD +390652251 marco.franceschini@gmail.com

Locations
Italy
IRCCS San Raffaele Pisana Recruiting
Roma, Italy, 00161
Contact: Patrizio Sale, MD       patrizio.sale@gmail.com   
Contact: Marco Franceschini, MD       marco.franceschini@sanraffaele.it   
Principal Investigator: Patrizio Sale, MD         
Sub-Investigator: Marco Franceschini, MD         
Auxilium Viate Volterra Recruiting
Volterra, Italy
Contact: Federico Posteraro, MD       f.posteraro@riabilitazione-volterra.it   
Contact: Stefano Mazzoleni, Phd       s.mazzoleni@sssup.it   
Principal Investigator: Federico Posteraro, MD         
Sub-Investigator: Stefano Mazzoleni, PhD         
Sponsors and Collaborators
IRCCS San Raffaele
Investigators
Principal Investigator: Patrizio Sale, MD IRCCS San Raffaele Pisana Rome
  More Information

No publications provided

Responsible Party: Patrizio Sale , MD, Medical Doctor, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT01658111     History of Changes
Other Study ID Numbers: MIT02012EEG
Study First Received: July 24, 2012
Last Updated: August 31, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by IRCCS San Raffaele:
Stroke
Robots
EEG
EMG

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 20, 2014