Usability Testing of a Bilateral Activities of Daily Exercise Robot for Stroke Therapy

Withdrawn before enrolling · Not applicable

Conditions studied: Stroke, Cerebral Palsy

In brief

In stroke rehabilitation, unilateral training of the impaired limb after stroke is often the frequent strategy used over bilateral ones. However, the clinical need for bilateral training is supported by evidence that shows that unilateral training of the impaired limb does not automatically restore bimanual coordination and function. Increased focused is needed on developing more robot-assisted therapy that can train the impaired arm bilaterally and unilaterally. Controlling these robots is often difficult and requires a better understanding of the coupling effects of the left and right hand before and after a stroke. There is a need to develop robot-assisted therapy devices that can address coupled and uncoupled bimanual movements as well as symmetry as well as asymmetry in context of human bimanual actions along with the intermanual division of labor in various ADL tasks. This study focuses on bilateral training and the use of bio-inspired control algorithms to understand impairment and recovery on Bimanual Activities of Daily Living (ADLs) by stroke subjects in terms of the arm kinematics. Healthy subjects and those with hemiplegia due to a stroke or cerebral palsy will be evaluated by a member of the research team and asked to perform a battery of tasks to test the viability and usability of a bilateral robot system called BiADLER, which allows patients to complete daily tasks with varying levels of assistance to adapt task performance to each individual subject's performance. Subjects will to provide feedback to the researchers on their observations and thoughts about the therapy devices.

Key facts

Study ID

NCT02882646

Run by

University of Pennsylvania

People needed

0

Starts

2016-04-01

Expected to finish

2021-06-01

Last updated by the study team

2024-10-08

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Part A:
• Stroke and CP survivors greater than 18 years of age with hemiplegia and varying levels of impairment.
• The subject's stroke must have occurred at least 3 months prior to enrollment in the study.
• Healthy persons over the age of 18 with no upper limb impairment.
• Part B:
• Low to mid functioning CP and stroke survivors greater than 18 years of age with hemiplegia.
• The subject's stroke must have occurred at least 3 months prior to enrollment in the study.

You may not qualify if…

• The Montreal Cognitive Assessment (MoCA) to each study participant. After the administration of the MoCA, the PI and research team member will use their to expertise and discretion to determine whether the participant scored well enough on particular components of the MOCA that are of particular concern to this study, e.g. visuospatial acuity and concentration.
• Participants must be able to sit upright for 2 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.
• Participants enrolled in Part B cannot currently be receiving rehabilitation.
• Participants cannot have received Botox injections within the past 3 months.
• Participants cannot be suffering from contractures (chronic loss of joint motion) or debilitating spasticity in the upper extremity or any other neuromuscular disease.
• If a participant is 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.

Where it is running

• Penn Medicine Rittenhouse — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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