Robot-aided Therapy in Stroke Patients for Upper Limb Rehabilitation (MITEEG)
Recruitment status was: Recruiting
|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.|
- 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 ]
- Change from Baseline in Modified Ashworth Scale at 28 weeks. [ Time Frame: at inclusion, week 4 and week 28. ] [ Designated as safety issue: No ]
- Change from Baseline in Frenchay Arm Test at 28 weeks. [ Time Frame: at inclusion, week 4 and week 28. ] [ Designated as safety issue: No ]
|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)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01658111
|IRCCS San Raffaele Pisana|
|Roma, Italy, 00161|
|Auxilium Viate Volterra|
|Principal Investigator:||Patrizio Sale, MD||IRCCS San Raffaele Pisana Rome|