Stroke, Impaired Upper Extremity Function
Conditions
Keywords
stroke, function, arm, hand, robotic, therapy, motor, movement, treatment
Brief summary
The goal of this project is to develop and test a new robotic system to accommodate practice of tasks requiring reach, grasp and release of objects. Our previous work has shown that the MIME robot is safe and effective for improving reach in stroke subjects. But adequate control of hand movements is critical to a functional upper limb, and is often resistant to conventional therapeutic interventions. Many stroke survivors have residual ability to flex the fingers, but extension is often limited and impeded by increased passive stiffness in flexors, abnormal levels of increased tone in flexors and weakness in extensors. In a recent study, 38% of stroke survivors reported that impaired hand function was the most disabling motor impairment they faced.
Detailed description
Research Design: We hypothesize that: 1) Gains in proximal arm function (shoulder, elbow) immediately after robotic training will be greater than after dose-matched conventional therapy; 2) Unlike in previous studies, gains in hand function immediately after robotic training will be greater than after dose-matched conventional therapy. Methodology: In the first year of the study, we will develop a robotic system with the ability to assist hand movement. Since many stroke survivors in the subacute and chronic recovery stages have residual ability to flex the fingers but severely limited finger extension, we will build a hand exoskeleton that can apply precise extension forces to the digits of the hand. This exoskeleton will be integrated with the ARMin III arm exoskeleton so that tasks such as arm reach, grasp of an object and release of the object can be trained. In the last 2 years of the project, we will perform a pilot clinical trial comparing this new training paradigm to dose-matched conventional therapy in chronic stroke survivors. Outcome measures will be taken before training and immediately after training.
Interventions
DEVICErobotic therapy
12 sessions of robot therapy for arm and hand function
OTHERconventional functional training
12 sessions of conventional therapy for the arm and hand from a physical therapist
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* An ischemic or hemorrhagic stroke more than 6 months prior to entry into the study; * trace ability to move the wrist and fingers in extension; * voluntary shoulder elevation to approximately 45 deg; * be between the ages of 21 and 90.
Exclusion criteria
* Have cognitive deficits that could negatively affect their ability to complete protocols as evidenced by a score of 24 or less on the Folstein Mini - Mental State Examination (Bleeker, 1988); * have excessive pain in any joint of the affected extremity that could limit ability to cooperate with the protocols; * have an upper extremity injury or conditions prior to stroke that could limit participation; * have severe hemispatial neglect. * have a full score of 24 on the distal section of the Fugl-Myer test (FM) (Fugl-Meyer 1975); and * have severe sensory loss.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Test of Motor Function | before Training Period 1, after Training Period 1, before Training Period 2, after training Period 2 | This scale assesses motor impairments at the shoulder, elbow, wrist and fingers (Fugl-Meyer 1975). Individual subscores are added to create a total score that ranges from 0 to 66 points. A score of 66 indicates no impairment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Action Research Arm Test | before Training Period 1, after Training Period 1, before Training Period 2, after training Period 2 | This scale is a standardized assessment of functional limitations in the upper extremity. Individual subscores are summed to create a total score that ranges from 0 to 57 points. A score of 57 indicates no functional limitations. |
| A Motion Analysis Evaluation Will be Performed on Reach and Grasp Tasks. The Kinematics Will be Measured Using an Electromagnetic Tracker (Flock of Birds, Ascension Technology Corp., Burlington VT). | pre-treatment, post treatment | — |
Countries
United States
Participant flow
Recruitment details
Recruitment was through word of mouth with therapists at the outpatient clinics of the DC Veterans Affair Medical Center and the MedStar National Rehabilitation Hospital. Recruitment took place approximately between 9/2010 and 3/2012.
Pre-assignment details
Fourteen individuals were recruited. One subject was excluded due to a prior orthopedic injury and another subject did not meet the Folstein Mini-Mental State Examination criterion. Two subjects completed the protocol up through the initial training period and the washout period, but did not return for the second therapy block.
Participants by arm
| Arm | Count |
|---|---|
| Robotic Then Conventional 12 hours of robotic arm therapy, followed by a 1 month washout period, followed by 12 hours of conventional arm therapy with a physical therapist | 7 |
| Conventional Then Robotic 12 hours of conventional arm therapy with a physical therapist, followed by a 1 month washout period, followed by 12 hours of robotic arm therapy | 5 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Training Period 2 | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Conventional Then Robotic | Robotic Then Conventional | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 3 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 4 Participants | 8 Participants |
| Age, Continuous | 57.8 years STANDARD_DEVIATION 16.3 | 57.7 years STANDARD_DEVIATION 10.8 | 57.7 years STANDARD_DEVIATION 12.2 |
| Region of Enrollment United States | 5 Participants | 7 Participants | 12 Participants |
| Sex: Female, Male Female | 0 Participants | 3 Participants | 3 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 7 | 0 / 5 |
| serious Total, serious adverse events | 0 / 7 | 0 / 5 |
Outcome results
Primary
Fugl-Meyer Test of Motor Function
This scale assesses motor impairments at the shoulder, elbow, wrist and fingers (Fugl-Meyer 1975). Individual subscores are added to create a total score that ranges from 0 to 66 points. A score of 66 indicates no impairment.
Time frame: before Training Period 1, after Training Period 1, before Training Period 2, after training Period 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Robotic Then Conventional | Fugl-Meyer Test of Motor Function | Change from beginning to end of training period 1 | 1.9 units on a scale | Standard Deviation 4.6 |
| Robotic Then Conventional | Fugl-Meyer Test of Motor Function | Change from beginning to end of washout period | 1.3 units on a scale | Standard Deviation 4.4 |
| Robotic Then Conventional | Fugl-Meyer Test of Motor Function | Change from beginning to end of training period 2 | 1.6 units on a scale | Standard Deviation 3.6 |
| Conventional Then Robotic | Fugl-Meyer Test of Motor Function | Change from beginning to end of training period 1 | .8 units on a scale | Standard Deviation 2.9 |
| Conventional Then Robotic | Fugl-Meyer Test of Motor Function | Change from beginning to end of washout period | .8 units on a scale | Standard Deviation 3.9 |
| Conventional Then Robotic | Fugl-Meyer Test of Motor Function | Change from beginning to end of training period 2 | 1.6 units on a scale | Standard Deviation 2.3 |
Secondary
Action Research Arm Test
This scale is a standardized assessment of functional limitations in the upper extremity. Individual subscores are summed to create a total score that ranges from 0 to 57 points. A score of 57 indicates no functional limitations.
Time frame: before Training Period 1, after Training Period 1, before Training Period 2, after training Period 2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Robotic Then Conventional | Action Research Arm Test | Change from beginning to end of training period 1 | 4.6 units on a scale | Standard Deviation 3.5 |
| Robotic Then Conventional | Action Research Arm Test | Change from beginning to end of washout period | .4 units on a scale | Standard Deviation 2.9 |
| Robotic Then Conventional | Action Research Arm Test | Change from beginning to end of training period 2 | -2 units on a scale | Standard Deviation 5.9 |
| Conventional Then Robotic | Action Research Arm Test | Change from beginning to end of training period 1 | -.2 units on a scale | Standard Deviation 1.1 |
| Conventional Then Robotic | Action Research Arm Test | Change from beginning to end of washout period | 0 units on a scale | Standard Deviation 1.6 |
| Conventional Then Robotic | Action Research Arm Test | Change from beginning to end of training period 2 | 1.4 units on a scale | Standard Deviation 3 |
Secondary
A Motion Analysis Evaluation Will be Performed on Reach and Grasp Tasks. The Kinematics Will be Measured Using an Electromagnetic Tracker (Flock of Birds, Ascension Technology Corp., Burlington VT).
Time frame: pre-treatment, post treatment
Population: Data initially collected but could not interpret results due to a lack of resources and incomplete data analysis. No further staff, tools, or information is available to report conclusions.