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

W

Wyss Institute at Harvard University

Status

Completed

Conditions

Hemiplegic Stroke
Hemiplegic Cerebral Palsy

Treatments

Device: Isolated Orthosis for Thumb Actuation (IOTA)

Study type

Observational

Funder types

Other

Identifiers

NCT01973426
AMD-CS-0026

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

7 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

12 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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