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

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

Tracking Information
First Submitted Date October 24, 2013
First Posted Date October 31, 2013
Last Update Posted Date June 9, 2020
Study Start Date October 2013
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 20, 2014)
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).
Original Primary Outcome Measures
 (submitted: October 24, 2013)
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 1.5 hours. ]
We will examine this aim by evaluating participant performance on a Box and Block Task as well as a Peg Task. Both tasks are clinically relevant to the participant population. These tasks will be evaluated with no device worn, and with the IOTA device worn in four different modes (manual mode, cycle & repeat mode, wrist mode, and moon mode).
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluating Human-Machine Interfaces in a Robotic Thumb Orthosis
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
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Children with hemiplegic cerebral palsy or hemiplegic stroke.
Condition
  • Hemiplegic Stroke
  • Hemiplegic Cerebral Palsy
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.
Study Groups/Cohorts 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.
Intervention: Device: Isolated Orthosis for Thumb Actuation (IOTA)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 20, 2014)
12
Original Estimated Enrollment
 (submitted: October 24, 2013)
20
Actual Study Completion Date November 2017
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 7 Years to 16 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01973426
Other Study ID Numbers AMD-CS-0026
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Wyss Institute at Harvard University
Study Sponsor Wyss Institute at Harvard University
Collaborators
  • 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
PRS Account Wyss Institute at Harvard University
Verification Date June 2020