Evaluating Human-Machine Interfaces in a Robotic Thumb Orthosis

Completed

• Conditions: Hemiplegic Stroke; Hemiplegic Cerebral Palsy
• Interventions: Device: Isolated Orthosis for Thumb Actuation (IOTA)

• Registration Number: NCT01973426
• Lead Sponsor: Wyss Institute at Harvard University

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.

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 Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-24
• Study First Submitted QC: 2013-10-24
• Study First Posted: 2013-10-31
• Primary Completion: 2014-01
• Study Completion: 2017-11
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-05
• Last Update Posted: 2020-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children with limited control of their thumb	Isolated Orthosis for Thumb Actuation (IOTA)	Children afflicted by hemiplegic stroke or hemiplegic cerebral palsy who have lost the ability to actively (and accurately) control the thumb.

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Children's Hospital Boston; 🇺🇸 Boston, Massachusetts, United States