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The robot was no longer available to the study.
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Stroke survivors with hemiplegia will be evaluated by rehabilitation professionals and asked to perform a battery of assessments to test the viability and usability of a force-feedback robot that adapts to each individual subject's performance. Subsequently, they will be asked to complete post-assessment questionnaires that provide feedback to the researchers on their observations and thoughts about the therapy devices.
TheraDrive is a low-cost robotic system for post-stroke upper extremity rehabilitation. The system uses off-the-shelf computer gaming wheels with force feedback to help reduce motor impairment and improve function in the arms of stroke survivors. Preliminary results from various studies have shown that the original TheraDrive system lacked a robust mechanical linkage which could withstand the forces exerted by patients, lacked a patient-specific adaptive controller to deliver personalized therapy, and was not capable of delivering effective therapy to severely low-functioning patients. A new low-cost, high-force haptic robot with a single degree of freedom has been developed to address these concerns. This study has two purposes: first, to test the viability and usability of the new robot system alongside the original TheraDrive system; and second, to test if low-functioning patients benefit, and if so how much, from using force-feedback therapy as opposed to devices with zero impedance. This will be done by recruiting approximately 36 human subjects. Exercises will be performed by study subjects and an adaptive controller will monitor patient performance to ensure that exercises are difficult but doable, which is important for maintaining patient motivation. It is hypothesized that not only will the new system be viable, but that it will provide better robot-assisted therapy to a large variety of patients, especially low-functioning stroke survivors with hemiplegia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stroke survivors with low and moderate motor deficits | Other | Subjects with low and moderate motor deficits will 1) complete exercises with 2 commercial (joystick and wheel) and the Theradrive haptic robot after pre assessment 2) then experience 12 therapy sessions on the Theradrive haptic robot with Adaptive Feedback. 3) Assessments pre and post therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Haptic Robot Therapy with Games | Device | Commercial Joystick and Wheels Plus the Haptic TheraDrive Robot will be used. Haptic Theradrive is a low-cost robotic system for post-stroke upper extremity rehabilitation. The system uses off-the-shelf computer gaming wheels with force feedback to help reduce motor impairment and improve function in the arms of stroke survivors. |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl Meyer | The primary outcomes are motor control for the upper limb: Subjects completed tasks on scale; Motor scale maximum is 66. minimum is 0. Lower is more impaired. Higher is less impaired. | At 0 weeks |
| Box and Blocks | Measures ADL Function. Completed reach and grasp activities. Reached for 1 inch cube and placed with impaired arm. More blocks indicate higher function. Less blocks lower function | At Session 0. Pre-intervention |
| Tracking Accuracy | Tracking accuracy is measured using the normalized root mean square, which is a measure for error in tracking performance with respect to a desired goal. Root mean squared divided by the maximum error if person does not move. The higher the decimal the higher the error made. Lower is better performance. | At Session 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Grip Strength | Grip strength as measured by a dynamometer. Subjects were asked to squeeze a dynamometer with impaired arm. Higher forces mean better function | pre-intervention |
| Montreal Cognitive Assessment (MOCA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle J Johnson, PhD | PENN MEDICINE RITTENHOUSE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn Medicine Rittenhouse | Philadelphia | Pennsylvania | 19146 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19963475 | Background | Ruparel R, Johnson MJ, Strachota E, McGuire J, Tchekanov G. Evaluation of the TheraDrive system for robot/computer assisted motivating rehabilitation after stroke. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:811-4. doi: 10.1109/IEMBS.2009.5332386. | |
| 17946851 | Background | Johnson MJ, Ramachandran B, Paranjape RP, Kosasih JB. Feasibility study of TheraDrive: a low-cost game-based environment for the delivery of upper arm stroke therapy. Conf Proc IEEE Eng Med Biol Soc. 2006;2006:695-8. doi: 10.1109/IEMBS.2006.259971. |
| Label | URL |
|---|---|
| A computer model of the human arm: Predictive biomechanics for the theradrive rehabilitation system | View source |
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Stroke survivors over the age of 18 with hemiplegia, who are three months post event, and have varying levels of impairment in the upper extremities will be recruited. All use of the TheraDrive system will take place at the Rehabilitation Robotics Lab on the first floor of Penn Rittenhouse
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| ID | Title | Description |
|---|---|---|
| FG000 | Stroke Survivors With Varying Levels of Motor Impairment | Stroke survivors with varying levels of motor deficit impairment in their upper extremity. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Severe motor deficit participants were not included in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects With Varying Levels of Motor Impairment | Subjects with varying levels of motor impairments who are ages 18 and older. |
| 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 | The primary outcomes are motor control for the upper limb: Subjects completed tasks on scale; Motor scale maximum is 66. minimum is 0. Lower is more impaired. Higher is less impaired. | 6 subjects did not complete so not included in the analysis | Posted | Mean | Standard Deviation | score on a scale | At 0 weeks |
|
|
40 months
No adverse events were reported.
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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 | Haptic Robot Therapy With Games | Subjects with low and moderate motor deficits will 1) complete exercises with 2 commercial (joystick and wheel) and the Theradrive haptic robot after pre assessment 2) then experience 12 therapy sessions on the Theradrive haptic robot with Adaptive Feedback. 3) Assessments pre and post therapy. Haptic Robot Therapy with Games: Commercial Joystick and Wheels Plus the Haptic TheraDrive Robot will be used. Haptic Theradrive is a low-cost robotic system for post-stroke upper extremity rehabilitation. The system uses off-the-shelf computer gaming wheels with force feedback to help reduce motor impairment and improve function in the arms of stroke survivors. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle J Johnson | University of Pennsylvania | 215 893-2665 | johnmic@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 14, 2020 | Jul 14, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D006429 | Hemiplegia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
A brief 30-question test that takes around 10 to 12 minutes to complete and helps assess people for impairment in cognition domains. Maximum is 30. Minimum is 0; Low is <17 is severe cognitive impairment; a score 26 and higher is normal cognition.
| pre-intervention |
| Becks Depression Scale | Measures depression. The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression (Beck, et al., 1961). Maximum is 63 Total Score_______________Levels of Depression 1-10____________________These ups and downs are considered normal 11-16___________________ Mild mood disturbance 17-20___________________Borderline clinical depression 21-30___________________Moderate depression 31-40___________________Severe depression over 40__________________Extreme depression | Pre-intervention |
| 24968380 | Background | Theriault A, Nagurka M, Johnson MJ. Design and development of an affordable haptic robot with force-feedback and compliant actuation to improve therapy for patients with severe hemiparesis. IEEE Trans Haptics. 2014 Apr-Jun;7(2):161-74. doi: 10.1109/TOH.2013.51. |
| Participants |
|
| Sex: Female, Male | 6 persons did not complete all of the tracking tasks so the data was excluded. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
| Primary | Box and Blocks | Measures ADL Function. Completed reach and grasp activities. Reached for 1 inch cube and placed with impaired arm. More blocks indicate higher function. Less blocks lower function | 6 subjects did not complete so not included in the analysis | Posted | Mean | Standard Deviation | # of blocks | At Session 0. Pre-intervention |
|
|
|
| Primary | Tracking Accuracy | Tracking accuracy is measured using the normalized root mean square, which is a measure for error in tracking performance with respect to a desired goal. Root mean squared divided by the maximum error if person does not move. The higher the decimal the higher the error made. Lower is better performance. | 6 subjects did not complete so not included in the analysis | Posted | Mean | Standard Deviation | accuracy index | At Session 0 |
|
|
|
| Secondary | Grip Strength | Grip strength as measured by a dynamometer. Subjects were asked to squeeze a dynamometer with impaired arm. Higher forces mean better function | 6 subjects did not complete so not included in the analysis | Posted | Mean | Standard Deviation | lbs | pre-intervention |
|
|
|
| Secondary | Montreal Cognitive Assessment (MOCA) | A brief 30-question test that takes around 10 to 12 minutes to complete and helps assess people for impairment in cognition domains. Maximum is 30. Minimum is 0; Low is <17 is severe cognitive impairment; a score 26 and higher is normal cognition. | 6 subjects did not complete so not included in the analysis | Posted | Mean | Standard Deviation | units on a scale | pre-intervention |
|
|
|
| Secondary | Becks Depression Scale | Measures depression. The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression (Beck, et al., 1961). Maximum is 63 Total Score_______________Levels of Depression 1-10____________________These ups and downs are considered normal 11-16___________________ Mild mood disturbance 17-20___________________Borderline clinical depression 21-30___________________Moderate depression 31-40___________________Severe depression over 40__________________Extreme depression | 6 subjects did not complete so not included in the analysis | Posted | Mean | Standard Deviation | units on a scale | Pre-intervention |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |