IOTA: Evaluating Human-Machine Interfaces in a Robotic Thumb Orthosis

Sponsor

Wyss Institute at Harvard University (Other)

Overall Status

Completed

CT.gov ID

NCT01973426

Collaborator

Boston Children's Hospital (Other), Deborah Munroe Noonan Memorial Research Fund (Other)

Enrollment

Location

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hemiplegic Stroke Hemiplegic Cerebral Palsy	Device: Isolated Orthosis for Thumb Actuation (IOTA)

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.

The hypothesis for this work is that the IOTA will significantly improve the participant's performance on clinically relevant tasks.

Study Design

Study Type:

Observational

Actual Enrollment :

12 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

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

Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Jan 1, 2014

Actual Study Completion Date :

Nov 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Children with limited control of their thumb 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.

Arm

Intervention/Treatment

Children with limited control of their thumb

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.

Outcome Measures

Primary Outcome Measures

Investigate whether the IOTA can effectively facilitate a participant's ability to perform a specific set of clinically relevant tasks in a clinical setting. [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital Boston	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

Wyss Institute at Harvard University
Boston Children's Hospital
Deborah Munroe Noonan Memorial Research Fund

Investigators

Principal Investigator: Leia Stirling, Ph.D., Wyss Institute at Harvard University
Principal Investigator: Annette Correia, OT, Boston Children's Hospital