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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01973426
First Posted: October 31, 2013
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Boston Children’s Hospital
Deborah Munroe Noonan Memorial Research Fund
Information provided by (Responsible Party):
Wyss Institute at Harvard University
  Purpose
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 Intervention
Hemiplegic Stroke Hemiplegic Cerebral Palsy Device: Isolated Orthosis for Thumb Actuation (IOTA)

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Wyss Institute at Harvard University:

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. [ 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).


Enrollment: 12
Study Start Date: October 2013
Estimated Study Completion Date: July 2018
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01973426


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     History of Changes
Other Study ID Numbers: AMD-CS-0026
First Submitted: October 24, 2013
First Posted: October 31, 2013
Last Update Posted: November 6, 2017
Last Verified: October 2017

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