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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic then Conventional | Experimental | robotic arm therapy first, conventional therapy second |
|
| Conventional then Robotic | Experimental | conventional therapy first, robotic therapy second |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| robotic therapy | Device | 12 sessions of robot therapy for arm and hand function |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | before Training Period 1, after Training Period 1, before Training Period 2, after training Period 2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | before Training Period 1, after Training Period 1, before Training Period 2, after training Period 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter S. Lum, PhD | VA Medical Center, DC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Medical Center, DC | Washington D.C. | District of Columbia | 20422 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24297763 | Result | Brokaw EB, Nichols D, Holley RJ, Lum PS. Robotic therapy provides a stimulus for upper limb motor recovery after stroke that is complementary to and distinct from conventional therapy. Neurorehabil Neural Repair. 2014 May;28(4):367-76. doi: 10.1177/1545968313510974. Epub 2013 Dec 2. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Training Period 1 |
| |||||||||||||
| Washout Period |
| |||||||||||||
| Training Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Conventional Then Robotic |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | before Training Period 1, after Training Period 1, before Training Period 2, after training Period 2 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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The limited therapy hours could mask potential gains that would have been made with additional therapy. Due to the small sample size, these results need to be confirmed in a larger scale study using a parallel study design.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Lum, PhD | Washington DC Veterans Affairs Medical Center | 202-319-5181 | lum@cua.edu |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| conventional functional training | Other | 12 sessions of conventional therapy for the arm and hand from a physical therapist |
|
| robotic therapy | Device | 12 sessions of robot therapy for arm and hand function |
|
| conventional functional training | Other | 12 sessions of conventional therapy for the arm and hand from a physical therapist |
|
| 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 |
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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
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | before Training Period 1, after Training Period 1, before Training Period 2, after training Period 2 |
|
|
|
| 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). | 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. | Posted | pre-treatment, post treatment |
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | 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 | 0 | 5 | 0 | 5 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Change from beginning to end of training period 2 |
|