Burke-Hocoma Efficiency Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Burke-Hocoma Efficiency Study

Conditions
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Hemiparesis, Hemiplegia

Intervention / Treatment
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* Device: Hocoma ArmeoSpring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral or bilateral upper extremity hemiparesis/hemiplegia Upper extremity Fugl-Meyer Assessment Score between 7-60 (Neither hemiplegic nor fully recovered motor function of the shoulder, elbow, wrist) Exclusion Criteria: Inability to follow 1-2 step commands Fixed joint contracture Unable to tolerate repetitious movement exhibited by pain greater than 5 on Likert Scale Any device dependent restrictions

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 60 Minutes ArmeoSpring (1:1)<br>60 minutes of therapy 3x per week for 6 weeks working one-on-one with a clinician for duration of session. | Device: Hocoma ArmeoSpring<br>* 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.<br>|
| Experimental: 60 Minutes ArmeoSpring (2:1)<br>60 minutes of therapy 3x per week for 6 weeks with one clinician supervising 2 participants. | Device: Hocoma ArmeoSpring<br>* 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.<br>|
| Active Comparator: 30 Minutes ArmeoSpring (1:1)<br>30 minutes of therapy 3x per week for 6 weeks working one-on-one with a clinician for duration of session. | Device: Hocoma ArmeoSpring<br>* 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.<br>|
| Experimental: 30 Minutes ArmeoSpring (2:1)<br>30 minutes of therapy 3x per week for 6 weeks with one clinician supervising 2 participants. | Device: Hocoma ArmeoSpring<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |