Children's Hospital Boston
Boston, Massachusetts, 02115, United States
NCT Number: NCT01973426
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.
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Notify Me7 year–16 year
All sexes
Observational
Boston, Massachusetts, 02115, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Time frame: 1 study session per participant, lasting up to 2 hours.
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).
Wyss Institute at Harvard University
Other
Development and Evaluation of a Human-Machine Interface for Grasp Assistance Using a Robotic Thumb Orthosis in Children With Hemiplegic Cerebral Palsy and Hemiplegic Stroke
Acronym: IOTA
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