Survivors and Caregivers FAQ
Questions for Stroke Survivors and Caregivers
Availability, Cost & Insurance
How much does the IpsiHand cost?
We have several purchase plans based on your needs. Make sure you are on our mailing list to receive further information.
Does insurance cover the IpsiHand?
Will my HSA or FSA cover the IpsiHand?
About Clinical Trials & Using the IpsiHand
Are there any clinical trials I can participate in?
I had a brain injury, can I use the IpsiHand?
I have a child who had a stroke. Can they use the IpsiHand?
Do I have to be seeing an occupational therapist or physical therapist to qualify to use the IpsiHand?
No, we can work with your clinician if you are currently enrolled in a rehabilitation therapy program. In addition, our Clinical Team consists of experienced Occupational Therapists with advanced certifications to provide you with assistance and information for screening and set-up of the IpsiHand System.
How long would I need to use the IpsiHand to see potential results?
One hundred percent of clinical trial participants saw an improvement in their arm and/or hand function following participation in the study. Our clinical trials demonstrated clinically significant arm and hand improvement for 66.7% of trial participants. The IpsiHand study protocols required the use of the device approximately 1 hour per day, 5 to 7 days a week for a total of at least 12 weeks in patients 6 or more months post-stroke. Participants in our clinical trials used the IpsiHand system at home for the duration of the study.
Qualifications and using the IpsiHand
I had a brain injury, can I use the IpsiHand?
I have a child who had a stroke. Can they use the IpsiHand?
When will the IpsiHand be available?
The IpsiHand will be available for potential candidates at select locations throughout the US this year. Make sure you are on our mailing list to receive updates about our location for trialing the device.
Are there any clinical trials I can participate in?
Do I have to be seeing an occupational therapist or physical therapist to qualify to use the IpsiHand?
No, we can work with your clinician if you are currently enrolled in a rehabilitation therapy program. In addition, our Clinical Team consists of experienced Occupational Therapists with advanced certifications to provide you with assistance and information for screening and set-up of the IpsiHand System.
How long would I need to use the IpsiHand to see potential results?
One hundred percent of clinical trial participants saw an improvement in their arm and/or hand function following participation in the study. Our clinical trials demonstrated clinically significant arm and hand improvement for 66.7% of trial participants. The IpsiHand study protocols required the use of the device approximately 1 hour per day, 5 to 7 days a week for a total of at least 12 weeks in patients 6 or more months post-stroke. Participants in our clinical trials used the IpsiHand system at home for the duration of the study.
Other questions
What does the "Ipsi" mean in IpsiHand?
The reason we call it the IpsiHand is because the prefix “ipsi” means the same. After a stroke occurs on one side of your brain, affecting the opposite side of your body causing weakness.
For example, if the stroke occurred on the left side of your brain, you may have weakness or spastic muscles on the right side of your body. The IpsiHand may train your brain to control the hand on the same side that the brain wave is coming from.
What is De Novo approval?
FDA De Novo approval establishes a new medical device type and approves that the device is safe to be used. De Novo classified devices did not fit into an established category and there were no equivalent devices on the market at the time of approval.