Burke-Hocoma Efficiency Study
- Conditions
- HemiplegiaHemiparesis
- Interventions
- Device: Hocoma ArmeoSpring
- Registration Number
- NCT03555825
- Lead Sponsor
- Burke Medical Research Institute
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 60 Minutes ArmeoSpring (1:1) Hocoma ArmeoSpring 60 minutes of therapy 3x per week for 6 weeks working one-on-one with a clinician for duration of session. 30 Minutes ArmeoSpring (1:1) Hocoma ArmeoSpring 30 minutes of therapy 3x per week for 6 weeks working one-on-one with a clinician for duration of session. 60 Minutes ArmeoSpring (2:1) Hocoma ArmeoSpring 60 minutes of therapy 3x per week for 6 weeks with one clinician supervising 2 participants. 30 Minutes ArmeoSpring (2:1) Hocoma ArmeoSpring 30 minutes of therapy 3x per week for 6 weeks with one clinician supervising 2 participants.
- Primary Outcome Measures
Name Time Method Change in Upper Extremity Fugl Meyer Assessment Baseline, immediately after intervention, 3 month follow up Impairment measure of gross and fine motor upper extremity movements
- Secondary Outcome Measures
Name Time Method Stroke Impact Scale Baseline, immediately after intervention, 3 month follow up Quality of life measure; Consists of 59 items and assesses 8 domains; Minimum score 0= no recovery, Maximum score 100= full recovery
Patient Satisfaction Survey/Enjoyment Scale Baseline, immediately after intervention, 3 month follow up Self-report of experience with device and supervision; 20 question scale with 0= no satisfaction/enjoyment, 100= extremely satisfied
Short Form Health Survey- 36 Baseline, immediately after intervention, 3 month follow up Self-report questionnaire of health status; minimum score of 0= severe disability and 100 = no disability.
Box and Blocks Test Baseline, immediately after intervention, 3 month follow up Timed measure of gross manual dexterity
Grip Strength Baseline, immediately after intervention, 3 month follow up Measure of force generated by exerting maximal grip
Trial Locations
- Locations (1)
Burke Medical Research Institute
🇺🇸White Plains, New York, United States