Clinical trial NCT02772809: Usability Testing of Affordable Haptic Robots for Stroke Therapy
Official title: Usability Testing of Affordable Haptic Robots for Stroke Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Hemiplegia
Keywords: stroke
hemiplegia
rehabilitation
robotics
neuroplasticity
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2016-05-16
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fugl Meyer
timeFrame: At 0 weeks
measure: Box and Blocks
timeFrame: At Session 0. Pre-intervention
measure: Tracking Accuracy
timeFrame: At Session 0
Secondary outcomes:
measure: Grip Strength
timeFrame: pre-intervention
measure: Montreal Cognitive Assessment (MOCA)
timeFrame: pre-intervention
measure: Becks Depression Scale
timeFrame: Pre-intervention
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Medicine Rittenhouse
state: Pennsylvania
Study officials:
affiliation: PENN MEDICINE RITTENHOUSE
name: Michelle J Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruparel R, Johnson MJ, Strachota E, McGuire J, Tchekanov G. Evaluation of the TheraDrive system for robot/computer assisted motivating rehabilitation after stroke. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:811-4. doi: 10.1109/IEMBS.2009.5332386.
citation: Johnson MJ, Ramachandran B, Paranjape RP, Kosasih JB. Feasibility study of TheraDrive: a low-cost game-based environment for the delivery of upper arm stroke therapy. Conf Proc IEEE Eng Med Biol Soc. 2006;2006:695-8. doi: 10.1109/IEMBS.2006.259971.
citation: Theriault A, Nagurka M, Johnson MJ. Design and development of an affordable haptic robot with force-feedback and compliant actuation to improve therapy for patients with severe hemiparesis. IEEE Trans Haptics. 2014 Apr-Jun;7(2):161-74. doi: 10.1109/TOH.2013.51.