Evaluating Human-Machine Interfaces in a Robotic Thumb Orthosis (IOTA)

• ClinicalTrials.gov Identifier: NCT01973426
• Recruitment Status: Completed
• First Posted: October 31, 2013
• Last Update Posted: June 9, 2020
• Sponsor: Wyss Institute at Harvard University
• Collaborators: Boston Children's Hospital; Deborah Munroe Noonan Memorial Research Fund
• Information provided by (Responsible Party): Wyss Institute at Harvard University

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
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.

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.

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: October 2013
• Actual Primary Completion Date: January 2014
• Actual Study Completion Date: November 2017

Groups and Cohorts

Group/Cohort

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 :

1. 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. ]
   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

• Ages Eligible for Study: 7 Years to 16 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Children with hemiplegic cerebral palsy or hemiplegic stroke.

Criteria

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

United States, Massachusetts

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

More Information

• Responsible Party: Wyss Institute at Harvard University
• ClinicalTrials.gov Identifier: NCT01973426
• Other Study ID Numbers: AMD-CS-0026
• First Posted: October 31, 2013
• Last Update Posted: June 9, 2020
• Last Verified: June 2020

Keywords provided by Wyss Institute at Harvard University:

Robot; Thumb; Orthosis; Hemiplegia; Hemiplegic Stroke; Hemiplegic Cerebral Palsy; Stroke; Cerebral Palsy; Grasp assistance

Additional relevant MeSH terms:

Stroke; Cerebral Palsy; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Damage, Chronic