Evaluating Human-Machine Interfaces in a Robotic Thumb Orthosis

Hemiplegic Cerebral Palsy Clinical Trial

— IOTA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01973426
• Other study ID #: AMD-CS-0026
• Status: Completed
• Start date: October 2013
• Est. completion date: November 2017

Study information

• Verified date: June 2020
• Source: Wyss Institute at Harvard University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2017
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Hemiplegic Cerebral Palsy
• Hemiplegic Stroke
• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Wyss Institute at Harvard University	Boston Children’s Hospital, Deborah Munroe Noonan Memorial Research Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	1 study session per participant, lasting up to 2 hours.