Overview

This trial is active, not recruiting.

Conditions hemiplegic stroke, hemiplegic cerebral palsy
Treatment isolated orthosis for thumb actuation (iota)
Sponsor Wyss Institute at Harvard University
Collaborator Children's Hospital Boston
Start date October 2013
End date January 2014
Trial size 12 participants
Trial identifier NCT01973426, AMD-CS-0026

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Children afflicted by hemiplegic stroke or hemiplegic cerebral palsy who have lost the ability to actively (and accurately) control the thumb.
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.

Primary Outcomes

Measure
Investigate whether the IOTA can effectively facilitate a participant's ability to perform a specific set of clinically relevant tasks in a clinical setting.
time frame: 1 study session per participant, lasting up to 2 hours.

Eligibility Criteria

Male or female participants from 7 years up to 16 years old.

Inclusion Criteria: - Be between 7 - 16 years old - Have a clinical diagnosis of hemiplegic cerebral palsy or hemiplegic stroke causing a thumb contracture affecting one hand - Not have a diagnosis of dystonia - Have completed at least a 6-week post-operative period following hand surgery (if applicable; self-reported) - Be able to follow instructions (as determined by their attending Occupational Therapist) - Not be allergic to nylon or lycra

Additional Information

Official title 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
Principal investigator Leia Stirling, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Wyss Institute at Harvard University.