Robot Aided Rehabilitation - Multi-joint Evaluations
Status: | Recruiting |
---|---|
Conditions: | Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - 85 |
Updated: | 6/17/2018 |
Start Date: | May 7, 2018 |
End Date: | September 30, 2020 |
Contact: | Chunyang Zhang, M.D. |
Email: | ChunyangZhang@som.umaryland.edu |
Phone: | (410) 706-8625 |
Robot-Aided Diagnosis, Passive-Active Arm Motor and Sensory Rehabilitation Post Stroke: Aim 1
Sensory and motor impairments following stroke can lead to substantial disability involving
the arm and hand. The investigator hypothesized that excessive local and cross-coupled
stiffness, diminished individuation and proprioceptive acuity will be present among multiple
degree of freedom in the upper limb. The stiffness and spasticity will increase with time
post-stroke. The objective of this study is to quantify the progression throughout the arm
and hand during recovery from stroke. The investigator will measure the clinical assessment
scores, and neuromechanical properties including range of motion, active and passive cross
coupling, and spasticity by the IntelliArm robot.
the arm and hand. The investigator hypothesized that excessive local and cross-coupled
stiffness, diminished individuation and proprioceptive acuity will be present among multiple
degree of freedom in the upper limb. The stiffness and spasticity will increase with time
post-stroke. The objective of this study is to quantify the progression throughout the arm
and hand during recovery from stroke. The investigator will measure the clinical assessment
scores, and neuromechanical properties including range of motion, active and passive cross
coupling, and spasticity by the IntelliArm robot.
Sensorimotor impairments following stroke can lead to substantial disability involving the
upper extremity. These impairments often involve complex pathological changes across multiple
joints and multiple degrees of freedom of the arm and hand, thereby rendering them difficult
to diagnose and treat. Many potential mechanisms, such as muscle weakness, motoneuronal
hyperexcitability, and elevated passive joint impedance, can contribute to the impairments,
thereby making it difficult to discern where best to focus treatment.
Objectives: The objectives of this study are to quantify the progression of neuromechanical
properties throughout the upper extremity during recovery from stroke.
Specific Aim 1: The specific aim is to examine neuromechanical properties throughout the
entire upper extremity and corticomotor excitability in stroke survivors over a period of 6
months and throughout the progression from the acute to the subacute to the chronic phases of
recovery.
Hypothesis: Excessive local and cross-coupled stiffness, heteronymous reflexes, corticomotor
excitability, and diminished individuation and proprioceptive acuity will be present among
multiple degree of freedom in the upper limb. The stiffness and spasticity will increase with
time post-stroke.
The aim of this study will be addressed through a longitudinal evaluation of stroke survivors
over the first 6 months following the stroke. Specifically, upper extremity control and
neuromechanical properties will be measured at 7 different time points over the six months.
36 stroke survivors from 18-85 years old will be recruited over the duration of the study. A
group of 20 healthy subjects will be recruited to obtain the normal values of the
neuromuscular and biomechanical properties.
In an initial screening session, after the subject has consented, a research personnel will
check the subject's health status and conduct clinical examinations in order to determine if
the subject meets the inclusion and exclusion criteria. During the screening session, the
subject will participate in several clinical assessments. The screening evaluations will take
about one half hour.
If the subject qualifies for the study, the subject will participate in evaluation sessions
at 7 time points spaced throughout the study. For each evaluation session, participants will
be asked to come to our laboratories. Evaluation of participants will have neuromechanical
and clinical components. The neuromechanical components of the evaluation will take
approximately 3 hours, and the clinical evaluation will need about 2.5 hours.
Neuromechanical evaluations: In diagnosing the multi-joint and multi-degree of freedom (DOF)
neuromechanical changes at the upper impaired limb, the IntelliArm will operate both passive
and active modes. During neuromechanical evaluations, the subject will sit upright on a
barber's chair and the trunk will be strapped to the backrest of the chair. The subject's
arm, forearm and hand will be strapped to the corresponding braces which are attached on the
robotic arm. The relevant servomotor-axles of the IntelliArm are aligned with the subject's
arm at the shoulder, elbow, wrist, and metacarpophalangeal (MCP) joints. The adjustments will
be made for the robotic arm to work properly with each subject.
Electromyography (EMG) system may be employed for recording the muscle activities at the
upper impaired limb. The skin over the muscle belly will be cleaned with an alcohol pad and
may be shaved by disposable razors. Self-adhesive electrodes will be placed on the cleaned
sites and connected to the instrument and computer. The surface electrodes may be put on
several different muscle bellies, including Flexor digitorum superficialis (FDS), Extensor
digitorum (ED), Flexor carpi radialis (FCR), Extensor carpi radialis longus (ECRL), Biceps
Brachii (BB), Triceps Brachii long head (TBLH), Deltoid anterior (DA), and Deltoid posterior
(DP).
After all preparations are made, the evaluation will begin with the passive movement first.
In the passive mode, the multi-joint arm robot will move the shoulder, elbow, wrist and
fingers of the impaired arm of stroke survivors throughout the ROMs both simultaneously and
individually in well-controlled spatial and temporal patterns with multi-axis torques and
positions measured at the shoulder, elbow, wrist and MCP joints. Those joints will be moved
one at a time or all of them will be moved together randomly, and the movements will be
repeated for up to 5 times in each condition. After finishing the evaluation of passive
motion, the participant will randomly be asked to move each joint of the upper limb or move
the whole upper limb from one place to another, and will need each participant to repeating
the movement for up to 5 times in each condition. Each neuromechanical evaluation will take
approximately 3 hours.
The joint torque and angular displacement of each joint will be recorded. During the
evaluation sessions, participant's reflex responses and muscle activities, such as
hyperexcitability of the flexors and voluntary contractions of agonist and antagonist muscles
at each joint, will be recorded and monitored through the skin electrodes with wireless EMG
system. The electrodes are just used for recording the signal generated by the muscles and
the participant will not feel any shocks during the evaluations. Non-invasive
electroencephalography (EEG) electrodes may be attached on the scalp to record brain activity
signals. A video or some photos may be taken as an option to evaluate the movement patterns
during the evaluations.
Measures of stiffness and of hyperexcitability of the finger/wrist flexor muscles, namely
spasticity and relaxation time, will also be made using techniques investigators have
implemented successfully in the past. Spasticity of wrist/hand muscles will be measured as
the reflex response to imposed rotation of the wrist joint. A servomotor will create either
fast wrist rotation to invoke a stretch reflex or slow constant-velocity rotation to measure
nominally passive stiffness. Wrist angle, angular velocity, and torque are recorded for
analysis of spasticity. EMG recordings will be obtained with surface electrodes from selected
superficial muscles. Relaxation time will be quantified by examining flexor muscle activity.
The subject will be instructed to grip maximally upon hearing an audible tone. The subject
should then relax the grip as quickly as possible after hearing a second tone. The relaxation
time is defined as elapsed time from the second tone to the point at which the flexor muscle
magnitude returns to the baseline level + three standard deviations.
Clinical evaluations: During clinical evaluations subjects will undergo a battery of
standardized clinical assessments. These assessments require subjects to complete functional
movements and tasks using the arms and hands. The clinical assessments to be administered
include those listed below.
Screening Mini Mental State Exam Chedoke McMaster Stroke Assessment: Impairment Inventory of
Arm and Hand
Full Evaluation Sessions Graded Wolf Motor Function Test (WMFT) Fugl-Meyer Upper Extremity
(FMUE) Chedoke McMaster Stroke Assessment: Impairment Inventory of Arm and Hand Action
Research Arm Test (ARAT) Nottingham Sensory Assessment Modified Ashworth Scale (MAS) Grip
Strength & Pinch Strength
upper extremity. These impairments often involve complex pathological changes across multiple
joints and multiple degrees of freedom of the arm and hand, thereby rendering them difficult
to diagnose and treat. Many potential mechanisms, such as muscle weakness, motoneuronal
hyperexcitability, and elevated passive joint impedance, can contribute to the impairments,
thereby making it difficult to discern where best to focus treatment.
Objectives: The objectives of this study are to quantify the progression of neuromechanical
properties throughout the upper extremity during recovery from stroke.
Specific Aim 1: The specific aim is to examine neuromechanical properties throughout the
entire upper extremity and corticomotor excitability in stroke survivors over a period of 6
months and throughout the progression from the acute to the subacute to the chronic phases of
recovery.
Hypothesis: Excessive local and cross-coupled stiffness, heteronymous reflexes, corticomotor
excitability, and diminished individuation and proprioceptive acuity will be present among
multiple degree of freedom in the upper limb. The stiffness and spasticity will increase with
time post-stroke.
The aim of this study will be addressed through a longitudinal evaluation of stroke survivors
over the first 6 months following the stroke. Specifically, upper extremity control and
neuromechanical properties will be measured at 7 different time points over the six months.
36 stroke survivors from 18-85 years old will be recruited over the duration of the study. A
group of 20 healthy subjects will be recruited to obtain the normal values of the
neuromuscular and biomechanical properties.
In an initial screening session, after the subject has consented, a research personnel will
check the subject's health status and conduct clinical examinations in order to determine if
the subject meets the inclusion and exclusion criteria. During the screening session, the
subject will participate in several clinical assessments. The screening evaluations will take
about one half hour.
If the subject qualifies for the study, the subject will participate in evaluation sessions
at 7 time points spaced throughout the study. For each evaluation session, participants will
be asked to come to our laboratories. Evaluation of participants will have neuromechanical
and clinical components. The neuromechanical components of the evaluation will take
approximately 3 hours, and the clinical evaluation will need about 2.5 hours.
Neuromechanical evaluations: In diagnosing the multi-joint and multi-degree of freedom (DOF)
neuromechanical changes at the upper impaired limb, the IntelliArm will operate both passive
and active modes. During neuromechanical evaluations, the subject will sit upright on a
barber's chair and the trunk will be strapped to the backrest of the chair. The subject's
arm, forearm and hand will be strapped to the corresponding braces which are attached on the
robotic arm. The relevant servomotor-axles of the IntelliArm are aligned with the subject's
arm at the shoulder, elbow, wrist, and metacarpophalangeal (MCP) joints. The adjustments will
be made for the robotic arm to work properly with each subject.
Electromyography (EMG) system may be employed for recording the muscle activities at the
upper impaired limb. The skin over the muscle belly will be cleaned with an alcohol pad and
may be shaved by disposable razors. Self-adhesive electrodes will be placed on the cleaned
sites and connected to the instrument and computer. The surface electrodes may be put on
several different muscle bellies, including Flexor digitorum superficialis (FDS), Extensor
digitorum (ED), Flexor carpi radialis (FCR), Extensor carpi radialis longus (ECRL), Biceps
Brachii (BB), Triceps Brachii long head (TBLH), Deltoid anterior (DA), and Deltoid posterior
(DP).
After all preparations are made, the evaluation will begin with the passive movement first.
In the passive mode, the multi-joint arm robot will move the shoulder, elbow, wrist and
fingers of the impaired arm of stroke survivors throughout the ROMs both simultaneously and
individually in well-controlled spatial and temporal patterns with multi-axis torques and
positions measured at the shoulder, elbow, wrist and MCP joints. Those joints will be moved
one at a time or all of them will be moved together randomly, and the movements will be
repeated for up to 5 times in each condition. After finishing the evaluation of passive
motion, the participant will randomly be asked to move each joint of the upper limb or move
the whole upper limb from one place to another, and will need each participant to repeating
the movement for up to 5 times in each condition. Each neuromechanical evaluation will take
approximately 3 hours.
The joint torque and angular displacement of each joint will be recorded. During the
evaluation sessions, participant's reflex responses and muscle activities, such as
hyperexcitability of the flexors and voluntary contractions of agonist and antagonist muscles
at each joint, will be recorded and monitored through the skin electrodes with wireless EMG
system. The electrodes are just used for recording the signal generated by the muscles and
the participant will not feel any shocks during the evaluations. Non-invasive
electroencephalography (EEG) electrodes may be attached on the scalp to record brain activity
signals. A video or some photos may be taken as an option to evaluate the movement patterns
during the evaluations.
Measures of stiffness and of hyperexcitability of the finger/wrist flexor muscles, namely
spasticity and relaxation time, will also be made using techniques investigators have
implemented successfully in the past. Spasticity of wrist/hand muscles will be measured as
the reflex response to imposed rotation of the wrist joint. A servomotor will create either
fast wrist rotation to invoke a stretch reflex or slow constant-velocity rotation to measure
nominally passive stiffness. Wrist angle, angular velocity, and torque are recorded for
analysis of spasticity. EMG recordings will be obtained with surface electrodes from selected
superficial muscles. Relaxation time will be quantified by examining flexor muscle activity.
The subject will be instructed to grip maximally upon hearing an audible tone. The subject
should then relax the grip as quickly as possible after hearing a second tone. The relaxation
time is defined as elapsed time from the second tone to the point at which the flexor muscle
magnitude returns to the baseline level + three standard deviations.
Clinical evaluations: During clinical evaluations subjects will undergo a battery of
standardized clinical assessments. These assessments require subjects to complete functional
movements and tasks using the arms and hands. The clinical assessments to be administered
include those listed below.
Screening Mini Mental State Exam Chedoke McMaster Stroke Assessment: Impairment Inventory of
Arm and Hand
Full Evaluation Sessions Graded Wolf Motor Function Test (WMFT) Fugl-Meyer Upper Extremity
(FMUE) Chedoke McMaster Stroke Assessment: Impairment Inventory of Arm and Hand Action
Research Arm Test (ARAT) Nottingham Sensory Assessment Modified Ashworth Scale (MAS) Grip
Strength & Pinch Strength
Inclusion Criteria:
1. First focal unilateral lesion, ischemic or hemorrhagic
2. Had a stroke less than a month prior to enrollment
3. Rated between stages 1-4 on the Chedoke McMaster Stroke Assessment Impairment
Inventory: Stage of Recovery of the Arm
4. Rated between stages 1-4 on the Chedoke McMaster Stroke Assessment Impairment
Inventory: Stage of Recovery of the Hand
Exclusion Criteria:
1. Apraxia
2. Other unrelated or musculoskeletal injuries
3. Unable to sit in a chair for 3 consecutive hours
4. Score of less than 22 on the Mini Mental Status Exam
5. Poor fit into equipment used in study which compromises proper use. This will be
determined by the judgment of study staff
We found this trial at
1
site
621 West Lombard Street
Baltimore, Maryland 21201
Baltimore, Maryland 21201
(410) 706-7101
Phone: 410-706-8625
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