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| ID | Type | Description | Link |
|---|---|---|---|
| 1RC3NS070646-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| The Cleveland Clinic | OTHER |
| Emory University | OTHER |
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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The purpose of this research is to evaluate a therapy delivery system for stroke patients that provide accessible, affordable stroke care. User-friendly home therapy robots and a telerehabilitation system are combined to monitor and provide therapy that is accessible for patients in rural and underserved locations. The robotic-based home therapy intervention will produce significantly greater improvement in upper extremity motor function than Usual and Customary Care enhanced with a (non-robotic) home therapy upper extremity rehabilitation program at the end of 8 weeks of home therapy.
The primary purpose of this proposal is to evaluate a combined clinic/home robotic-based stroke therapy delivery and monitoring system in rural and underserved locations that provides accessible, effective and affordable care for stroke survivors with residual limb impairment. The study is a prospective, single-blind, multi-site Randomized Controlled Trial. A total of 96 patients within 6 months post-stroke will be enrolled and randomly assigned to one of two groups: robotic based home therapy or a self administered (non-robotic) home therapy program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hand Mentor Therapy | Experimental | Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks |
|
| Control | Active Comparator | Self administered home therapy program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hand Mentor (TM) robotic stroke therapy device | Device | The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance. |
| Measure | Description | Time Frame |
|---|---|---|
| Action Research Arm Test (ARAT) | The amount of recovery of arm-hand function is measured with the Action Research Arm Test (ARAT). The ARAT assesses activity limitations of the upper extremity. It includes 19 items divided into four subscales: grasp, grip, pinch, and gross movement. Scores range from 0-to-57 with a higher score indicating a better outcome. | End of treatment at 8 weeks post enrolment |
| Measure | Description | Time Frame |
|---|---|---|
| Wolf Motor Function Test | The Wolf Motor Function Test (WMFT) is used to measure the degree of function using timed tasks. The WMFT is a 17-item measure used to assess activity limitations of the upper extremity. It is comprised of 2 strength items and 15 timed task performance items. The task performance items begin with the measurement of simple proximal movements and progress to more complex distal and whole limb movements. The WMFT yields two scores: 1) a functional ability score quantifying quality of performance, and 2) a timed score quantifying speed of performance in seconds. A shorter time is better outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jay Alberts, PhD | The Cleveland Clinic | Principal Investigator |
| Steve L Wolf, PhD | Emory University Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University School of Medicine | Atlanta | Georgia | 30322 | United States | ||
| Cleveland Clinic Foujndation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26122686 | Derived | Linder SM, Rosenfeldt AB, Bay RC, Sahu K, Wolf SL, Alberts JL. Improving Quality of Life and Depression After Stroke Through Telerehabilitation. Am J Occup Ther. 2015 Mar-Apr;69(2):6902290020p1-10. doi: 10.5014/ajot.2015.014498. | |
| 25782693 | Derived | Wolf SL, Sahu K, Bay RC, Buchanan S, Reiss A, Linder S, Rosenfeldt A, Alberts J. The HAAPI (Home Arm Assistance Progression Initiative) Trial: A Novel Robotics Delivery Approach in Stroke Rehabilitation. Neurorehabil Neural Repair. 2015 Nov-Dec;29(10):958-68. doi: 10.1177/1545968315575612. Epub 2015 Mar 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hand Mentor Therapy | Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance. |
| FG001 | Control | Self administered home therapy program Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Power analysis to achieve .80 power, alpha=0.05, two-tailed, in differential change across groups in Fugl-Meyer during the trial.
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| ID | Title | Description |
|---|---|---|
| BG000 | Hand Mentor Therapy | Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Action Research Arm Test (ARAT) | The amount of recovery of arm-hand function is measured with the Action Research Arm Test (ARAT). The ARAT assesses activity limitations of the upper extremity. It includes 19 items divided into four subscales: grasp, grip, pinch, and gross movement. Scores range from 0-to-57 with a higher score indicating a better outcome. | Posted | Mean | Standard Deviation | units on a scale | End of treatment at 8 weeks post enrolment |
|
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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 | Hand Mentor Therapy | Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lost balance and fell | General disorders | Non-systematic Assessment | Lost balance and fell |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Koeneman, PhD | Kinetic Muscles | 602-677-5256 | jimkoeneman509@gmail.com |
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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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|
| Home Therapy Program | Device | Subjects in the control group will be instructed in a self administered home therapy program |
|
| End of treatment at 8 weeks post enrolment |
| Fugl-Meyer Upper Extremity Test | Upper Extremity neurological impairment will be measured using the Fugl-Meyer Upper Extremity Test (FMA). The FMA is an impairment-based measure consisting of 33 movements with higher scores indicating increased ability of the patient to move out of synergistic patterns toward more isolated movements. Movement quality of the affected UE is compared to the non-affected UE on 0-2 ordinal scale with 0 indicating no movement at all, 1 indicating partial movement of the affected extremity, and 2 indicating movement equivalent to the non-affected UEs. The score ranges from 0-to-66. | End of Treatment at 8 weeks post enrolment |
| Stroke Impact Scale (SIS) | Quality of Life changes are measured with the Stroke Impact Scale questionnaire. The SIS is a self-rated QOL questionnaire that addresses several domains following stroke: physical strength, memory, feelings and emotions, communication, activities of daily living (ADL), mobility, hand use, meaningful activities, and overall percentage recovery from the stroke. We report the Hand Function subscale, which ranges from 0-to-100. A higher score reflects better hand function. | End of treatment at 8 weeks post enrolment |
| Cleveland |
| Ohio |
| 44195 |
| United States |
| 23280269 | Derived | Linder SM, Rosenfeldt AB, Reiss A, Buchanan S, Sahu K, Bay CR, Wolf SL, Alberts JL. The home stroke rehabilitation and monitoring system trial: a randomized controlled trial. Int J Stroke. 2013 Jan;8(1):46-53. doi: 10.1111/j.1747-4949.2012.00971.x. |
| Adverse Event |
|
| BG001 | Control | Self administered home therapy program Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control | Self administered home therapy program Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program |
|
|
| Secondary | Wolf Motor Function Test | The Wolf Motor Function Test (WMFT) is used to measure the degree of function using timed tasks. The WMFT is a 17-item measure used to assess activity limitations of the upper extremity. It is comprised of 2 strength items and 15 timed task performance items. The task performance items begin with the measurement of simple proximal movements and progress to more complex distal and whole limb movements. The WMFT yields two scores: 1) a functional ability score quantifying quality of performance, and 2) a timed score quantifying speed of performance in seconds. A shorter time is better outcome. | Posted | Geometric Mean | Standard Deviation | Seconds | End of treatment at 8 weeks post enrolment |
|
|
|
| Secondary | Fugl-Meyer Upper Extremity Test | Upper Extremity neurological impairment will be measured using the Fugl-Meyer Upper Extremity Test (FMA). The FMA is an impairment-based measure consisting of 33 movements with higher scores indicating increased ability of the patient to move out of synergistic patterns toward more isolated movements. Movement quality of the affected UE is compared to the non-affected UE on 0-2 ordinal scale with 0 indicating no movement at all, 1 indicating partial movement of the affected extremity, and 2 indicating movement equivalent to the non-affected UEs. The score ranges from 0-to-66. | Posted | Mean | Standard Deviation | units on a scale | End of Treatment at 8 weeks post enrolment |
|
|
|
| Secondary | Stroke Impact Scale (SIS) | Quality of Life changes are measured with the Stroke Impact Scale questionnaire. The SIS is a self-rated QOL questionnaire that addresses several domains following stroke: physical strength, memory, feelings and emotions, communication, activities of daily living (ADL), mobility, hand use, meaningful activities, and overall percentage recovery from the stroke. We report the Hand Function subscale, which ranges from 0-to-100. A higher score reflects better hand function. | Posted | Mean | Standard Deviation | units on a scale | End of treatment at 8 weeks post enrolment |
|
|
|
| 0 |
| 51 |
| 6 |
| 51 |
| EG001 | Control | Self administered home therapy program Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program | 0 | 48 | 5 | 48 |
| Ulcer | Gastrointestinal disorders | Ulcer | Non-systematic Assessment | Subject experienced an ulcer |
|
| Recurrent stroke | Vascular disorders | stroke | Non-systematic Assessment | One patient suffered a transient ischemic stroke and was withdrawn from the study. |
|
| Depression | Psychiatric disorders | Depression | Non-systematic Assessment | A patient reported that she felt she was regressing, and she was frustrated and depressed. |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |