- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03508037
Therapy to Improve Reaching Movement in Upper Limb
Hybrid Robotic System and EEG Based on an Adaptative and Associative Assistance for Rehabilitation of Reaching Movements After Stroke
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Oscar Herrero
- Phone Number: + 34 645 16 31 66
- Email: oscar.herrero@cajal.csic.es
Study Locations
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Madrid, Spain, 28034
- Recruiting
- Centro de Referencia Estatal de Atención al Daño Cerebral (CEADAC)
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Contact:
- Carlos Gonzalez
- Phone Number: +34 696993123
- Email: cgonzaalted@imserso.es
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- With response to Transcranial Magnetic Stimulation (TMS)
- Cortical or sub-cortical stroke patients
- With a score in the range of 22-44 on Fugl-Meyer scale or 2-4 on the Motor Assessment Scale
- With visible cortical patterns registered by BCI
- Subjects that tolerate electrical stimulation and that present a motor response
- Subjects with cognitive ability to follow instructions and perform the indicated tasks
Exclusion Criteria:
- Subjects with neurological injury prior to stroke or more than two events
- Patients with implanted devices
- Patients with severe motor paralysis
- Patients with epilepsy
- Patient with vision or hearing impairment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental group
The subject receives the Functional Electrical Stimulation (FES) when he or she has the intention to move.
It is obtained through electroencephalography.
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First, the subject performs twenty reaching movements without assistance with the damaged arm resting on a robot (ArmeoSpring), with the aim of finding the Contingent Negative Variation (CNV).
Then, he or she executes five courses of twenty movements receiving functional electrical stimulation (FES), either at the moment in which he or she wishes to move (experimental group), or half a second before or after (control group).
Other Names:
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Active Comparator: Control group
The subject receives the Functional Electrical Stimulation (FES) after o before (0.5 seconds) when he or she has the intention to move.
It is obtained through electroencephalography.
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First, the subject performs twenty reaching movements without assistance with the damaged arm resting on a robot (ArmeoSpring), with the aim of finding the Contingent Negative Variation (CNV).
Then, he or she executes five courses of twenty movements receiving functional electrical stimulation (FES), either at the moment in which he or she wishes to move (experimental group), or half a second before or after (control group).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in muscular balance's of upper limb
Time Frame: One week before the intervention. One week after the intervention. One month after the intervention. (The duration of the intervention is three weeks).
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The function of muscle strength testing is to evaluate the complaint of weakness, often when there is a suspected neurologic disease. It is an integral part of the neurologic exam, especially for patients with stroke, brain injury, and others neurologic problems. The most commonly accepted method of evaluating muscle strength is the Medical Research Council Manual Muscle Testing scale. This method involves testing key muscles from the upper and lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale accordingly: 0 No muscle activation
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One week before the intervention. One week after the intervention. One month after the intervention. (The duration of the intervention is three weeks).
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Changes in modified scale of Answorth
Time Frame: One week before the intervention. One week after the intervention. One month after the intervention.
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Modified Ashworth Scale tests resistance to passive movement about a joint with varying degrees of velocity. Scores range from 0-4, with 6 choices. A score of 1 indicates no resistance, and 6 indicates rigidity. Modified Ashworth Scale Scores: 0 (0) - No increase in muscle tone 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension. 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement). 2 (3) - More marked increase in musce tone through most of the ROM, but affect part(s) easily moved. 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension |
One week before the intervention. One week after the intervention. One month after the intervention.
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Changes in FIM
Time Frame: One week before the intervention. One week after the intervention. One month after the intervention.
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Provides a uniform system of measurement for disability based on the International Classification of Impairment, Disabilities and Handicaps; measures the level of a patient's disability and indicates how much assistance is required for the individual to carry out activities of daily living. Contains 18 items composed of:
Scores range from 18 (lowest) to 126 (highest) indicating level of function. Dimensions assessed include:
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One week before the intervention. One week after the intervention. One month after the intervention.
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Changes in Quick Dash
Time Frame: One week before the intervention. One week after the intervention. One month after the intervention.
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Assessment of symptoms and functionality in upper limb's pathology.
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One week before the intervention. One week after the intervention. One month after the intervention.
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Changes in Action Research Arm Test (ARAT)
Time Frame: One week before the intervention. One week after the intervention. One month after the intervention.
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Assessment of coordination and manipulative skills in tasks of grasping and reaching objects. The ARAT's is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3) Performs test normally 2) Completes test, but takes abnormally long or has great difficulty 1) Performs test partially 0) Can perform no part of test Lyle's decision rules:
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One week before the intervention. One week after the intervention. One month after the intervention.
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Changes in Quebec User Evaluation of Satisfaction with Assistive Technology (QTEST)
Time Frame: One week before the intervention. One week after the intervention. One month after the intervention.
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The Quebec User Evaluation of Satisfaction with assistive Technology (QUEST) was designed to measure the level of satisfaction attribute to assistive technologies. It does so using 27 variables which are scored in terms of perceived importance and satisfaction. For each of the 12 items, rate your satisfaction with your assistive device and the related services you experienced by using the following scale of 1 to 5. For each of the 12 items, the user has to rate their satisfaction with the assistive device and the related services their experienced by using the following scale of 1 to 5. 1 - Not satisfied at all. 2- Not very satisfied. 3 - More or less satisfied. 4 - Quite satisfied. 5 -Very satisfied. |
One week before the intervention. One week after the intervention. One month after the intervention.
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Changes in the Self-Assessment Manikin (SAM)
Time Frame: One week before the intervention. One week after the intervention. One month after the intervention.
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To assess the emotional response of user to different stimulus.
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One week before the intervention. One week after the intervention. One month after the intervention.
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Changes in isometric force
Time Frame: One week before the intervention. One week after the intervention. One month after the intervention.
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To evaluate the isometric strength of the patient
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One week before the intervention. One week after the intervention. One month after the intervention.
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Changes in range of movement
Time Frame: One week before the intervention. One week after the intervention. One month after the intervention.
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To evaluate the range of movement performed by the patient
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One week before the intervention. One week after the intervention. One month after the intervention.
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Changes in Lawton & Brody
Time Frame: One week before the intervention. One week after the intervention. One month after the intervention.
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Assessment basic and instrumental activities of daily life.
It evaluates the following categories and subcategories.
For each of the latest, the subject has to circle the item description that most closely resembles their highest functional level (either 0 or 1): A. Ability to Use Telephone; B. Shopping; C.Food Preparation; D.Housekeeping; E. Laundry; F. Mode of Transportation; G. Responsibility for Own Medications; H. Ability to Handle Finances.
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One week before the intervention. One week after the intervention. One month after the intervention.
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Changes in Box and Block
Time Frame: One week before the intervention. One week after the intervention. One month after the intervention.
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The Box and Block Test assesses unilateral gross manual dexterity.
Individuals are seated at a table, facing a rectangular box that is divided into two square compartments of equal dimension by means of a partition.
One hundred and fifty, 2.5 cm, colored, wooden cubes or blocks are placed in one compartment or the other.
The individual is instructed to move as many blocks as possible, one at a time, from one compartment to the other for a period of 60 seconds.
The BBT is scored by counting the number of blocks carried over the partition from one compartment to the other during the one-minute trial period.
Patient's hand must cross over the partition in order for a point to be given, and blocks that drop or bounce out of the second.
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One week before the intervention. One week after the intervention. One month after the intervention.
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Changes in System Usability Scale (SUS)
Time Frame: One week before the intervention. One week after the intervention. One month after the intervention.
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The System Usability Scale (SUS) provides a "quick and dirty", reliable tool for measuring the usability. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. When a SUS is used, participants are asked to score the following 10 items with one of five responses that range from Strongly Agree to Strongly disagree: I think that I would like to use this system frequently. I found the system unnecessarily complex. I thought the system was easy to use. I think that I would need the support of a technical person to be able to use this system. I found the various functions in this system were well integrated. I thought there was too much inconsistency in this system. I would imagine that most people would learn to use this system very quickly. I found the system very cumbersome to use. I felt very confident using the system. I needed to learn a lot of things before I could get going with this system. |
One week before the intervention. One week after the intervention. One month after the intervention.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Motor Evoked Potentials (MEPs).
Time Frame: One week before the intervention. One week after the intervention. One month after the intervention.
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To assess the motor evoked potential.
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One week before the intervention. One week after the intervention. One month after the intervention.
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jose Luis Pons, Centro Superior de Investigaciones Científicas (CSIC)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSEULS-PI-106/2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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