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| Name | Class |
|---|---|
| Hocoma | UNKNOWN |
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The ArmeoSpring device is an exoskeleton (3 joints and 6 degrees of freedom) with integrated springs. The investigators hypothesize that 3 days of training for 6 weeks with the Hocoma Armeo Spring device will be efficient and more effective than one on one ArmeoSpring therapy.
In the proposed study, 20 stable subacute and chronic stroke patients will be placed in two groups: 2:1 treatment for 3 weeks (2 patients on 2 robots with one therapist; 60 minutes on robot) then 1 on 1 intervention with the therapist (60 minutes of Hocoma Armeo Spring robotic training) or visa versa. Patients will be assessed using robotic kinematics and standardized occupational therapy motor assessments. The extreme precision afforded by robotic physical rehabilitation therapies makes them an appealing and growing field in rehabilitation.
Determining efficiency of new technologies, while maintaining the highest quality of care, is of priority in the medical field at this time. Devices such as the ArmeoSpring could lead to reduced disability, thereby increasing function and improving quality of life in patients experiencing neurological illness or injury. The ArmeoSpring has potential to decrease cost for both the provider and patient over time while providing more engaging, evidence-based therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 60 Minutes ArmeoSpring (1:1) | Active Comparator | 60 minutes of therapy 3x per week for 6 weeks working one-on-one with a clinician for duration of session. |
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| 60 Minutes ArmeoSpring (2:1) | Experimental | 60 minutes of therapy 3x per week for 6 weeks with one clinician supervising 2 participants. |
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| 30 Minutes ArmeoSpring (1:1) | Active Comparator | 30 minutes of therapy 3x per week for 6 weeks working one-on-one with a clinician for duration of session. |
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| 30 Minutes ArmeoSpring (2:1) | Experimental | 30 minutes of therapy 3x per week for 6 weeks with one clinician supervising 2 participants. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hocoma ArmeoSpring | Device | A spring-loaded upper extremity exoskeleton with 3 joints and 6 degrees of freedom. Participants use the more affected upper extremity to control and engage in therapeutic games. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Upper Extremity Fugl Meyer Assessment | Impairment measure of gross and fine motor upper extremity movements | Baseline, immediately after intervention, 3 month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction Survey/Enjoyment Scale | Self-report of experience with device and supervision; 20 question scale with 0= no satisfaction/enjoyment, 100= extremely satisfied | Baseline, immediately after intervention, 3 month follow up |
| Box and Blocks Test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tomoko Kitago, MD | Burke Medical Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Burke Medical Research Institute | White Plains | New York | 10605 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32250331 | Result | Wuennemann MJ, Mackenzie SW, Lane HP, Peltz AR, Ma X, Gerber LM, Edwards DJ, Kitago T. Dose and staffing comparison study of upper limb device-assisted therapy. NeuroRehabilitation. 2020;46(3):287-297. doi: 10.3233/NRE-192993. |
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There is no plan to make individual participant data available to other researchers at this time.
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| ID | Term |
|---|---|
| D010291 | Paresis |
| D006429 | Hemiplegia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Group 1: 60 minutes of Armeo treatment, 3 times per week for 6 weeks. (Half the patients will be assigned to 1:1 therapy and the other half to 2:1 therapy) Group 2: 30 minutes of Armeo treatment, 3 times per week for 6 weeks. (Half the patients will be assigned to 1:1 therapy and the other half to 2:1 therapy)
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Timed measure of gross manual dexterity |
| Baseline, immediately after intervention, 3 month follow up |
| Grip Strength | Measure of force generated by exerting maximal grip | Baseline, immediately after intervention, 3 month follow up |
| Short Form Health Survey- 36 | Self-report questionnaire of health status; minimum score of 0= severe disability and 100 = no disability. | Baseline, immediately after intervention, 3 month follow up |
| Stroke Impact Scale | Quality of life measure; Consists of 59 items and assesses 8 domains; Minimum score 0= no recovery, Maximum score 100= full recovery | Baseline, immediately after intervention, 3 month follow up |
| D010243 | Paralysis |