Robot-aided Therapy in Stroke Patients for Upper Limb Rehabilitation (MITEEG)
Primary Purpose
Stroke
Status
Terminated
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Robot Group
Traditional physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Stroke, Robots, EEG, EMG
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.
Sites / Locations
- IRCCS San Raffaele Roma
- Auxilium Viate Volterra
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Traditional physiotherapy
Robot Group
Arm Description
Each subject will receive 4 weeks of traditional upper limb rehabilitation treatment (20 sessions, 5 days a week for 4 weeks).
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).
Outcomes
Primary Outcome Measures
Change from Baseline in Fugl-Meyer Scale at 28 weeks.
Change from Baseline in Box and Block Test at 28 weeks.
Secondary Outcome Measures
Change from Baseline in Modified Ashworth Scale at 28 weeks.
Full Information
NCT ID
NCT01658111
First Posted
July 24, 2012
Last Updated
September 30, 2022
Sponsor
IRCCS San Raffaele Roma
1. Study Identification
Unique Protocol Identification Number
NCT01658111
Brief Title
Robot-aided Therapy in Stroke Patients for Upper Limb Rehabilitation
Acronym
MITEEG
Official Title
Robot-aided Therapy in Acute Stroke Patients for the Upper Limb Rehabilitation With Long-term Follow-up.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Terminated
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS San Raffaele Roma
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
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;
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Robots, EEG, EMG
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Traditional physiotherapy
Arm Type
Active Comparator
Arm Description
Each subject will receive 4 weeks of traditional upper limb rehabilitation treatment (20 sessions, 5 days a week for 4 weeks).
Arm Title
Robot Group
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Robot Group
Other Intervention Name(s)
MIT-MANUS/InMotion2
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Traditional physiotherapy
Other Intervention Name(s)
FKT
Intervention Description
Active or passive exercises.
Primary Outcome Measure Information:
Title
Change from Baseline in Fugl-Meyer Scale at 28 weeks.
Time Frame
at inclusion, week 4 and week 28
Title
Change from Baseline in Box and Block Test at 28 weeks.
Time Frame
at inclusion, week 4 and week 28.
Secondary Outcome Measure Information:
Title
Change from Baseline in Modified Ashworth Scale at 28 weeks.
Time Frame
at inclusion, week 4 and week 28.
Other Pre-specified Outcome Measures:
Title
Change from Baseline in Frenchay Arm Test at 28 weeks.
Time Frame
at inclusion, week 4 and week 28.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michela Goffredo, BME
Organizational Affiliation
IRCCS San Raffaele Rome
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS San Raffaele Roma
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Auxilium Viate Volterra
City
Volterra
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Robot-aided Therapy in Stroke Patients for Upper Limb Rehabilitation
We'll reach out to this number within 24 hrs