Hemiparesis, Hemiplegia
Conditions
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.
Interventions
DEVICEHocoma ArmeoSpring
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.
Sponsors
Hocoma
Burke Medical Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention 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)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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. |
| 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 |
Countries
United States
Outcome results
None listed