Reaching Training Based on Robotic Hybrid Assistance for Stroke Patients ( RETRAINER-S2 )
NCT ID: NCT03199833
Last Updated: 2017-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
68 participants
INTERVENTIONAL
2016-11-10
2018-05-31
Brief Summary
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Within the European project RETRAINER (grant agreement No 644721), the consortium developed a platform for the rehabilitation of the upper limb after stroke, which combines a passive forearm-hand orthosis for hand-wrist motion stabilization, selective fingers constraining and grasp movement facilitation, Functional Electrical Stimulation (FES) of the extrinsic hand flexor muscles and of the extrinsic hand extensor muscles, interactive objects, and voluntary effort. The system also provides a graphical user interface which helps the therapist set the training session and save the training data and parameters, and provides the subject a visual feedback about his/her active involvement in the exercise. The training consists of the execution of a series of exercises involving the affected arm during daily life activities. Typical exercises include controlled wrist flexion and extension, controlled fingers flexion and extension, anterior reaching and grasping on a plane or in the space, moving an object on a plane or in the space.
The aim of this clinical study it to evaluate the efficacy of this novel training platform on patients between two weeks and nine months after their first stroke, who preserved at least a visible muscle contraction for the arm and shoulder muscles. Participants are randomized in an experimental and a control group. The control group is trained with an advanced rehabilitative program, including physical training, occupational therapy, FES, and virtual reality, while the experimental group is trained with the RETRAINER system for about 30 minutes, in addition to the same program of the control group. The daily training time is the same for the two groups. The intervention consists of three sessions a week for nine weeks. Patients are assessed at baseline, soon after the end of the intervention, and in a 4-week follow-up visits. It is planned to recruit 68 subjects for this study. Since the RETRAINER platform was built on the up-to-date theory of motor re-learning, which supports task-oriented repetitive training, a close temporal association between motor intention and stimulated motor response, and an intensive and frequent training paradigm, the study's hypothesis is that the experimental group shows a greater treatment effect than the control group.
Detailed Description
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The stimulation frequency is set at 25 Hz, the pulse width is fixed at 300μs, while the stimulation intensity is set at the beginning of the training session on each muscle individually at a value tolerated by the subject and able to induce a functional movement.
Custom electrode arrays are placed over forearm muscle belly. A fast and automatic calibration procedure is required before the beginning of each session. This procedure aims at setting the current amplitude values for each Virtual Electrode in use.
The control interface of the system, implemented in .Net 4.6, provides a GUI including multiple software tools to organize rehabilitation exercises and monitor rehabilitation progress. The heart of the control interface is a State Machine, which drives both the parameterization and the execution of the exercises. Each exercise is divided into single tasks: the State Machine drives the exercise execution throughout the tasks, while the execution of each single task is controlled by the ECS. The ECS controls all the modules requiring real time constraints, such as the stimulator, the FES controller and the orthosis sensors. To keep the control interface and the ECS synchronized, a strict master slave concept using a custom made communication protocol was implemented, meaning that the ECS must not act independently, but only reacts to commands sent by the high level control. Transitions between states of the state machine and thus tasks of the exercise are triggered by angle sensors data, RFID data or a timer (depending on the task). Transitions have to fulfill certain conditions, so called guards. These guards are predefined for each task and have to be parameterized as described in the Section D. The GUI guides the user through the training by providing visual instructions and feedback. The workflow of a typical training session consists of four main phases: the setting, donning and parameterization of the system, and the training following a pre-defined sequence of exercises. The control interface supports the therapist and the patient throughout all the phases via the GUI. The setting starts with the therapist creating a new user, or selecting an existent one, calibrating the inertial sensors, and selecting the exercises. Afterwards, the donning phase starts with the placement of the electrode arrays for stimulation. Once the Virtual Electrodes placement and intensity is checked, the therapist should don the orthosis of appropriate size on the patient, and position the inertial sensors on the orthosis and on the fingers clasps. The following step is the calibration of the FES controller by means of the automatic procedure previously described. On the following training days, the setting and donning procedure is partly simplified since the therapist can load the settings of the previous day and eventually adjust them, and use the pre-identified orthoses that best fit the subject. A parameterization step is designed to set the guards of the State Machine. In this process the GUI guides the patient and the therapist through each task of the selected exercises with stimulation. The patient-specific parameters for each task, such as the target positions, the desired time for the execution of each task, and the time of the relax phases, are determined. At the end of the parameterization phase, all the parameters are stored and the training session can start. The training consists of the execution of a series of exercises involving the hand during daily life activities. Typical exercises are grasping an object, flexing and extending fingers, flexing and extending the wrist, anterior reaching on a plane or in the space, moving an object on a plane or in the space, with or without an object in the hand. The execution of the exercises is controlled by the control interface which leads the patient throughout the single tasks by means of both visual and audio messages via the GUI.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arms
RETRAINER-S2 \& Conventional Therapy 27 sessions, 3 sessions per week for a total of 9 weeks. Each session consists of 30-minute training with the RETRAINER-S2 system plus 60 minutes of conventional therapy. The training session is customized on the patients' need and can be adapted to their improvement during the intervention.
RETRAINER-S2
It consists of the execution of different exercises with the affected forearm-hand supported by the RETRAINER-S2 device. The subject is actively involved in the exercises and the system provides two types of support: wrist-fingers motion constraining and FES. The following exercises can be performed: controlled wrist flexion and wrist extension; controlled fingers flexion and extension; repeated grasping of an object; anterior reaching and grasping of an object; moving of objects on a plane or in space.
A subset of exercises is defined based on the patient's capability and the training time is equally shared between the selected exercises. The different training sessions can include different exercises and a different number of repetition for each exercise.
Conventional therapy
It consists of a combination of different treatment modalities among the following, based on the patient's specific needs:
* Upper limb passive motion
* Arm Cycle ergometer with or without FES
* Neuro Muscular Electrical Stimulation
* Upper limb exercises using augmented or virtual reality environment
* Occupational therapy exercises
* Constraint induced movement therapy
* Upper limb active movement (reaching, grasping, elevation, spatial orientation)
* Repetitive task training
* Mirror therapy
* Writing training
* Chemodenervation Therapy
Conventional Therapy
27 sessions, 3 sessions per week for a total of 9 weeks. Each session lasts about 90 minutes and consists of different training modalities typically used in the rehabilitation of the arm after stroke. The training session is customized on the patients' need and can be adapted to their improvement during the intervention.
Conventional therapy
It consists of a combination of different treatment modalities among the following, based on the patient's specific needs:
* Upper limb passive motion
* Arm Cycle ergometer with or without FES
* Neuro Muscular Electrical Stimulation
* Upper limb exercises using augmented or virtual reality environment
* Occupational therapy exercises
* Constraint induced movement therapy
* Upper limb active movement (reaching, grasping, elevation, spatial orientation)
* Repetitive task training
* Mirror therapy
* Writing training
* Chemodenervation Therapy
Interventions
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RETRAINER-S2
It consists of the execution of different exercises with the affected forearm-hand supported by the RETRAINER-S2 device. The subject is actively involved in the exercises and the system provides two types of support: wrist-fingers motion constraining and FES. The following exercises can be performed: controlled wrist flexion and wrist extension; controlled fingers flexion and extension; repeated grasping of an object; anterior reaching and grasping of an object; moving of objects on a plane or in space.
A subset of exercises is defined based on the patient's capability and the training time is equally shared between the selected exercises. The different training sessions can include different exercises and a different number of repetition for each exercise.
Conventional therapy
It consists of a combination of different treatment modalities among the following, based on the patient's specific needs:
* Upper limb passive motion
* Arm Cycle ergometer with or without FES
* Neuro Muscular Electrical Stimulation
* Upper limb exercises using augmented or virtual reality environment
* Occupational therapy exercises
* Constraint induced movement therapy
* Upper limb active movement (reaching, grasping, elevation, spatial orientation)
* Repetitive task training
* Mirror therapy
* Writing training
* Chemodenervation Therapy
Eligibility Criteria
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Inclusion Criteria
* Patients who have suffered a first stroke with major unilateral functional impairment
* Acute event between two weeks and nine months before study enrollment
* Motricity Index of the affected side must be under 80% of best expected performance.
* No major contralateral impairment must be present (Motricity Index of the non-affected side more than 80% of normality)
* Residual muscular activity for forearm muscles (MRC \> o = 1)
* Mini-Mental State Examination \> 20
Exclusion Criteria
* Pain due to Spasticity evaluated using Modified Ashworth Scale
* Previous history of major neurological or psychiatric disorders
* allergy to electrodes
18 Years
85 Years
ALL
No
Sponsors
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Ecole Polytechnique Fédérale de Lausanne
OTHER
Ab.Acus
OTHER
Control Systems Group, Technische Universität Berlin, Germany
OTHER
Ottobock Health Products GmbH, Wien, Austria
UNKNOWN
HASOMED GmbH
OTHER
Asklepios Neurological Clinic Falkenstein
OTHER
Technische Universität Wien, Austria
UNKNOWN
Dept. of Electronics, Informatics, Bioengineering, Politecnico di Milano, Italy
OTHER
Dr. Franco Molteni
OTHER
Responsible Party
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Dr. Franco Molteni
Clinical Director
Principal Investigators
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Franco Molteni, MD
Role: PRINCIPAL_INVESTIGATOR
Villa Beretta Rehabilitation Center
Locations
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Asklepios Neurologische Klinik Falkenstein
Königstein im Taunus, , Germany
Villa Beretta Rehabilitation Center
Costa Masnaga, Lecco, Italy
Countries
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Central Contacts
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Facility Contacts
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Karsten Krakow, MD
Role: primary
Giulio Gasperini, MD
Role: primary
Related Links
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Official web site of the project
Other Identifiers
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RETRAINER-S2
Identifier Type: -
Identifier Source: org_study_id