Usability Testing of Affordable Haptic Robots for Stroke Therapy



Status:Active, not recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:12/9/2017
Start Date:March 2014
End Date:October 2018

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Stroke survivors with hemiplegia will be evaluated by rehabilitation professionals and asked
to perform a battery of assessments to test the viability and usability of a force-feedback
robot that adapts to each individual subject's performance. Subsequently, they will be asked
to complete post-assessment questionnaires that provide feedback to the researchers on their
observations and thoughts about the therapy devices.

TheraDrive is a low-cost robotic system for post-stroke upper extremity rehabilitation. The
system uses off-the-shelf computer gaming wheels with force feedback to help reduce motor
impairment and improve function in the arms of stroke survivors. Preliminary results from
various studies have shown that the original TheraDrive system lacked a robust mechanical
linkage which could withstand the forces exerted by patients, lacked a patient-specific
adaptive controller to deliver personalized therapy, and was not capable of delivering
effective therapy to severely low-functioning patients. A new low-cost, high-force haptic
robot with a single degree of freedom has been developed to address these concerns. This
study has two purposes: first, to test the viability and usability of the new robot system
alongside the original TheraDrive system; and second, to test if low-functioning patients
benefit, and if so how much, from using force-feedback therapy as opposed to devices with
zero impedance. This will be done by recruiting approximately 36 human subjects. Exercises
will be performed by study subjects and an adaptive controller will monitor patient
performance to ensure that exercises are difficult but doable, which is important for
maintaining patient motivation. It is hypothesized that not only will the new system be
viable, but that it will provide better robot-assisted therapy to a large variety of
patients, especially low-functioning stroke survivors with hemiplegia.

Inclusion Criteria:

- Stroke survivors at least 18 years of age with hemiplegia.

- The subject's stroke must have occurred at least 3 months prior to enrollment in the
study.

- Low and Moderate functioning stroke survivors as measured by Fugl- Meyer

- Not depressed

- No more than Mild Cognitive Deficit

- Participants must be able to sit upright for 4 hours at a time in Part A of the study;
and 2 hours at a time, 3 days a week, for Part B of the study.

- The subject's stroke must have occurred at least 3 months prior to enrollment in the
study.

Exclusion Criteria:

- Greater than mild cognitive deficits

- Greater than mild depression. A member of the research team will administer Beck's
Depression Inventory (BDI) to each study participant over the phone. If the
participant is found to have greater than mild depression, as measured by the BDI,
they will not qualify for the study.

- Receiving rehabilitation on the upper limb.

- Received Botox injections within the past 3 months.

- Suffering from contractures (chronic loss of joint motion) or debilitating spasticity
in the upper extremity.

- Experiencing greater than mild pain, and/or the PI determines that the participant
should no longer continue working with the novel therapy devices, the study will be
stopped.
We found this trial at
1
site
Philadelphia, Pennsylvania 19146
?
mi
from
Philadelphia, PA
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