An observational study in Hemiplegic Stroke and Hemiplegic Cerebral Palsy, sponsored by Wyss Institute at Harvard University. Completed at 1 site in United States. Open to participants aged 7 Years to 16 Years. Per ClinicalTrials.gov, last updated 2020-06-09.
Sponsored by Wyss Institute at Harvard University · Observational
We plan to investigate whether the Isolated Orthosis for Thumb Actuation (IOTA) can effectively facilitate the ability of participants to perform a specific set of clinically relevant tasks conducted in a clinic setting.
Many Activities of Daily Living involve precision grasp and fine motor manipulation, such as putting toothpaste on a toothbrush or feeding oneself. However, children afflicted by stroke, cerebral palsy, or traumatic brain injury may lose the ability to actively (and accurately) control the thumb, and specifically abduct/adduct the carpometacarpal (CMC) joint and flex/extend the metacarpophalangeal (MCP) joint. We are testing the Isolated Orthosis for Thumb Actuation (IOTA), a device developed at the Wyss Institute at Harvard University in collaboration with Children's Hospital Boston, for assisting opposable thumb grasping tasks. The IOTA contains an adjustable brace fitted to the thumb and dorsum of the hand that is easy to put on and facilitates grasping motions through flexible cable-driven actuators that assist with CMC joint abduction and MCP joint extension.
In this pilot study, we plan to investigate whether the IOTA can effectively facilitate the ability of participants to perform a specific set of clinically relevant tasks conducted in a clinic setting.
The hypothesis for this work is that the IOTA will significantly improve the participant's performance on clinically relevant tasks.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 12 is below the median of 160 across 1,692 observational studies indexed under Stroke.
Browse Stroke studies →Wyss Institute at Harvard University is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Children with hemiplegic cerebral palsy or hemiplegic stroke.
Inclusion Criteria:
Children afflicted by hemiplegic stroke or hemiplegic cerebral palsy who have lost the ability to actively (and accurately) control the thumb.
Device: Isolated Orthosis for Thumb Actuation (IOTA)
In this pilot study, we plan to investigate whether the IOTA can effectively facilitate the ability of participants to perform a specific set of clinically relevant tasks conducted in a clinic setting. The IOTA is a device developed at the Wyss Institute at Harvard University, in collaboration with Children's Hospital Boston, for assisting opposable thumb grasping tasks. The IOTA contains an adjustable brace fitted to the thumb and dorsum of the hand that is easy to put on and facilitates grasping motions through flexible cable-driven actuators that assist with joint abduction and extension.
Investigate whether the IOTA can effectively facilitate a participant's ability to perform a specific set of clinically relevant tasks in a clinical setting.
We will examine this aim by evaluating participant performance on a Box and Block Task. This task is clinically relevant to the participant population. This task will be evaluated with no device worn at first, and then with the IOTA device worn in four different modes (manual mode, cycle \& repeat mode, wrist mode, and moon mode).
Time frame: 1 study session per participant, lasting up to 2 hours.
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Wyss Institute at Harvard University