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Therapy to Improve Reaching Movement in Upper Limb

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ClinicalTrials.gov Identifier: NCT03508037
Recruitment Status : Recruiting
First Posted : April 25, 2018
Last Update Posted : September 21, 2018
Sponsor:
Collaborators:
Centro de Referencia Estatal de Atención Al Daño Cerebral
Centro Universitario La Salle
Information provided by (Responsible Party):
Oscar Herrero Gimenez, Cajal Institute of the Spanish National Research Council

Tracking Information
First Submitted Date  ICMJE March 22, 2018
First Posted Date  ICMJE April 25, 2018
Last Update Posted Date September 21, 2018
Actual Study Start Date  ICMJE March 12, 2018
Estimated Primary Completion Date February 16, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2018)
  • 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). ]
    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
    1. Trace muscle activation, such as a twitch, without achieving full range of motion
    2. Muscle activation with gravity eliminated, achieving full range of motion
    3. Muscle activation against gravity, full range of motion
    4. Muscle activation against some resistance, full range of motion
    5. Muscle activation against examiner's full resistance, full range of motion
  • Changes in modified scale of Answorth [ Time Frame: One week before the intervention. One week after the intervention. One month after the intervention. ]
    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
  • Changes in FIM [ Time Frame: One week before the intervention. One week after the intervention. One month after the intervention. ]
    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:
    1. 13 motor tasks
    2. 5 cognitive tasks (considered basic activities of daily living) Tasks are rated on a 7-point ordinal scale that ranges from total assistance (or complete dependence) to complete independence.
    Scores range from 18 (lowest) to 126 (highest) indicating level of function. Dimensions assessed include:
    1. Eating
    2. Grooming
    3. Bathing
    4. Upper body dressing
    5. Lower body dressing
    6. Toileting
    7. Bladder management
    8. Bowel management
    9. Bed to chair transfer
    10. Toilet transfer
    11. Shower transfer
    12. Locomotion (ambulatory or wheelchair level)
    13. Stairs
    14. Cognitive comprehension
    15. Expression
    16. Social interaction
    17. Problem
  • Changes in Quick Dash [ Time Frame: One week before the intervention. One week after the intervention. One month after the intervention. ]
    Assessment of symptoms and functionality in upper limb's pathology.
  • Changes in Action Research Arm Test (ARAT) [ Time Frame: One week before the intervention. One week after the intervention. One month after the intervention. ]
    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:
    1. Patients who achieve a maximum score on the first (most difficult) item are credited with having scored 3 on all subsequent items on that scale.
    2. If the patient scores less than 3 on the first item, then the second item is assessed.
    3. This is the easiest item, and if patients score 0 then they are unlikely to achieve a score above 0 for the remainder of the items and are credited with a zero for the other items.
    4. The maximum score on the ARTS is 57 points (possible range 0 to 57).
  • 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. ]
    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.
  • Changes in the Self-Assessment Manikin (SAM) [ Time Frame: One week before the intervention. One week after the intervention. One month after the intervention. ]
    To assess the emotional response of user to different stimulus.
  • Changes in isometric force [ Time Frame: One week before the intervention. One week after the intervention. One month after the intervention. ]
    To evaluate the isometric strength of the patient
  • Changes in range of movement [ Time Frame: One week before the intervention. One week after the intervention. One month after the intervention. ]
    To evaluate the range of movement performed by the patient
  • Changes in Lawton & Brody [ Time Frame: One week before the intervention. One week after the intervention. One month after the intervention. ]
    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.
  • Changes in Box and Block [ Time Frame: One week before the intervention. One week after the intervention. One month after the intervention. ]
    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.
  • Changes in System Usability Scale (SUS) [ Time Frame: One week before the intervention. One week after the intervention. One month after the intervention. ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03508037 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2018)
Changes in Motor Evoked Potentials (MEPs). [ Time Frame: One week before the intervention. One week after the intervention. One month after the intervention. ]
To assess the motor evoked potential.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Therapy to Improve Reaching Movement in Upper Limb
Official Title  ICMJE Hybrid Robotic System and EEG Based on an Adaptative and Associative Assistance for Rehabilitation of Reaching Movements After Stroke
Brief Summary Strokes are caused by a bleed in the brain and can be life threatening. One common consequence is upper limb impairment. This causes stroke patients to be unable to use their arms and upper body to do simple tasks such as reaching or grasping. Currently, people with stroke undergo rehabilitation, which is usually done through a physical and occupational (daily living skills) therapies to improve their mobility (movement) with their upper limbs. However, this kind of treatment has limitations and often cannot help patients regain total mobility. There are alternative rehabilitation treatments that use new methods and technologies that may be able to help patients with stroke. Neuromodulaton therapies using brain-computer interfaces (BCI), which connects brain signals directly to a computer, have the potential to help patients. This type of therapy uses assistive devices such as electrical stimulation (electrical shocks or waves) and robots to help restore function to the areas affected by stroke. The aim of this study is to evaluate and the potential benefits that can be achieved by using assistive devices in rehabilitation sessions with stroke patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Stroke
  • Impairment Upper Limb
Intervention  ICMJE Other: Neuromodulation electroencephalographic signals and functional electrical stimulation based
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 Name: Neuromodulation
Study Arms  ICMJE
  • 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.
    Intervention: Other: Neuromodulation electroencephalographic signals and functional electrical stimulation based
  • 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.
    Intervention: Other: Neuromodulation electroencephalographic signals and functional electrical stimulation based
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 16, 2018)
16
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2019
Estimated Primary Completion Date February 16, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Oscar Herrero + 34 645 16 31 66 oscar.herrero@cajal.csic.es
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03508037
Other Study ID Numbers  ICMJE CSEULS-PI-106/2016
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Oscar Herrero Gimenez, Cajal Institute of the Spanish National Research Council
Study Sponsor  ICMJE Cajal Institute of the Spanish National Research Council
Collaborators  ICMJE
  • Centro de Referencia Estatal de Atención Al Daño Cerebral
  • Centro Universitario La Salle
Investigators  ICMJE
Principal Investigator: Jose Luis Pons Centro Superior de Investigaciones Científicas (CSIC)
PRS Account Cajal Institute of the Spanish National Research Council
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP