Clinical Trials Directory

Trials / Completed

CompletedNCT01973426

Evaluating Human-Machine Interfaces in a Robotic Thumb Orthosis

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

Status
Completed
Phase
Study type
Observational
Enrollment
12 (actual)
Sponsor
Wyss Institute at Harvard University · Academic / Other
Sex
All
Age
7 Years – 16 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DEVICEIsolated 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.

Timeline

Start date
2013-10-01
Primary completion
2014-01-01
Completion
2017-11-01
First posted
2013-10-31
Last updated
2020-06-09

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01973426. Inclusion in this directory is not an endorsement.