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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Children's Hospital Boston
Deborah Munroe Noonan Memorial Research Fund
Information provided by (Responsible Party):
Wyss Institute at Harvard University
ClinicalTrials.gov Identifier:
NCT01973426
First received: October 24, 2013
Last updated: April 15, 2014
Last verified: April 2014
  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. ] [ Designated as safety issue: No ]
    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: June 2014
Estimated Primary Completion Date: June 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

Ages Eligible for Study:   7 Years to 16 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01973426

Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Wyss Institute at Harvard University
Children's Hospital Boston
Deborah Munroe Noonan Memorial Research Fund
Investigators
Principal Investigator: Leia Stirling, Ph.D. Wyss Institute at Harvard University
Principal Investigator: Annette Correia, OT Children's Hospital Boston
  More Information

No publications provided

Responsible Party: Wyss Institute at Harvard University
ClinicalTrials.gov Identifier: NCT01973426     History of Changes
Other Study ID Numbers: AMD-CS-0026
Study First Received: October 24, 2013
Last Updated: April 15, 2014
Health Authority: United States: Institutional Review Board

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 Infarction
Cerebral Palsy
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Brain Damage, Chronic

ClinicalTrials.gov processed this record on September 18, 2014