Therapy to Improve Reaching Movement in Upper Limb
Primary Purpose
Stroke, Impairment Upper Limb
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Neuromodulation electroencephalographic signals and functional electrical stimulation based
Sponsored by

About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
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
Sites / Locations
- Centro de Referencia Estatal de Atención al Daño Cerebral (CEADAC)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental group
Control group
Arm Description
The subject receives the Functional Electrical Stimulation (FES) when he or she has the intention to move. It is obtained through electroencephalography.
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.
Outcomes
Primary Outcome Measures
Changes in muscular balance's of upper limb
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
Trace muscle activation, such as a twitch, without achieving full range of motion
Muscle activation with gravity eliminated, achieving full range of motion
Muscle activation against gravity, full range of motion
Muscle activation against some resistance, full range of motion
Muscle activation against examiner's full resistance, full range of motion
Changes in modified scale of Answorth
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
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:
13 motor tasks
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:
Eating
Grooming
Bathing
Upper body dressing
Lower body dressing
Toileting
Bladder management
Bowel management
Bed to chair transfer
Toilet transfer
Shower transfer
Locomotion (ambulatory or wheelchair level)
Stairs
Cognitive comprehension
Expression
Social interaction
Problem
Changes in Quick Dash
Assessment of symptoms and functionality in upper limb's pathology.
Changes in Action Research Arm Test (ARAT)
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:
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.
If the patient scores less than 3 on the first item, then the second item is assessed.
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.
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)
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)
To assess the emotional response of user to different stimulus.
Changes in isometric force
To evaluate the isometric strength of the patient
Changes in range of movement
To evaluate the range of movement performed by the patient
Changes in Lawton & Brody
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
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)
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.
Secondary Outcome Measures
Changes in Motor Evoked Potentials (MEPs).
To assess the motor evoked potential.
Full Information
NCT ID
NCT03508037
First Posted
March 22, 2018
Last Updated
September 20, 2018
Sponsor
Cajal Institute of the Spanish National Research Council
Collaborators
Centro de Referencia Estatal de Atención Al Daño Cerebral, Centro Universitario La Salle
1. Study Identification
Unique Protocol Identification Number
NCT03508037
Brief Title
Therapy to Improve Reaching Movement in Upper Limb
Official Title
Hybrid Robotic System and EEG Based on an Adaptative and Associative Assistance for Rehabilitation of Reaching Movements After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 12, 2018 (Actual)
Primary Completion Date
February 16, 2019 (Anticipated)
Study Completion Date
May 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cajal Institute of the Spanish National Research Council
Collaborators
Centro de Referencia Estatal de Atención Al Daño Cerebral, Centro Universitario La Salle
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Impairment Upper Limb
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Non-Randomized
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
The subject receives the Functional Electrical Stimulation (FES) when he or she has the intention to move. It is obtained through electroencephalography.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Neuromodulation electroencephalographic signals and functional electrical stimulation based
Other Intervention Name(s)
Neuromodulation
Intervention Description
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).
Primary Outcome Measure Information:
Title
Changes in muscular balance's of upper limb
Description
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
Trace muscle activation, such as a twitch, without achieving full range of motion
Muscle activation with gravity eliminated, achieving full range of motion
Muscle activation against gravity, full range of motion
Muscle activation against some resistance, full range of motion
Muscle activation against examiner's full resistance, full range of motion
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).
Title
Changes in modified scale of Answorth
Description
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
Time Frame
One week before the intervention. One week after the intervention. One month after the intervention.
Title
Changes in FIM
Description
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:
13 motor tasks
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:
Eating
Grooming
Bathing
Upper body dressing
Lower body dressing
Toileting
Bladder management
Bowel management
Bed to chair transfer
Toilet transfer
Shower transfer
Locomotion (ambulatory or wheelchair level)
Stairs
Cognitive comprehension
Expression
Social interaction
Problem
Time Frame
One week before the intervention. One week after the intervention. One month after the intervention.
Title
Changes in Quick Dash
Description
Assessment of symptoms and functionality in upper limb's pathology.
Time Frame
One week before the intervention. One week after the intervention. One month after the intervention.
Title
Changes in Action Research Arm Test (ARAT)
Description
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:
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.
If the patient scores less than 3 on the first item, then the second item is assessed.
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.
The maximum score on the ARTS is 57 points (possible range 0 to 57).
Time Frame
One week before the intervention. One week after the intervention. One month after the intervention.
Title
Changes in Quebec User Evaluation of Satisfaction with Assistive Technology (QTEST)
Description
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.
Time Frame
One week before the intervention. One week after the intervention. One month after the intervention.
Title
Changes in the Self-Assessment Manikin (SAM)
Description
To assess the emotional response of user to different stimulus.
Time Frame
One week before the intervention. One week after the intervention. One month after the intervention.
Title
Changes in isometric force
Description
To evaluate the isometric strength of the patient
Time Frame
One week before the intervention. One week after the intervention. One month after the intervention.
Title
Changes in range of movement
Description
To evaluate the range of movement performed by the patient
Time Frame
One week before the intervention. One week after the intervention. One month after the intervention.
Title
Changes in Lawton & Brody
Description
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.
Time Frame
One week before the intervention. One week after the intervention. One month after the intervention.
Title
Changes in Box and Block
Description
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.
Time Frame
One week before the intervention. One week after the intervention. One month after the intervention.
Title
Changes in System Usability Scale (SUS)
Description
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.
Time Frame
One week before the intervention. One week after the intervention. One month after the intervention.
Secondary Outcome Measure Information:
Title
Changes in Motor Evoked Potentials (MEPs).
Description
To assess the motor evoked potential.
Time Frame
One week before the intervention. One week after the intervention. One month after the intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oscar Herrero
Phone
+ 34 645 16 31 66
Email
oscar.herrero@cajal.csic.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Luis Pons
Organizational Affiliation
Centro Superior de Investigaciones Científicas (CSIC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Referencia Estatal de Atención al Daño Cerebral (CEADAC)
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Gonzalez
Phone
+34 696993123
Email
cgonzaalted@imserso.es
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Therapy to Improve Reaching Movement in Upper Limb
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