Clinical trial NCT01973426: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemiplegic Stroke
Hemiplegic Cerebral Palsy
Keywords: Robot
Thumb
Orthosis
Hemiplegia
Hemiplegic Stroke
Hemiplegic Cerebral Palsy
Stroke
Cerebral Palsy
Grasp assistance
Lead sponsor: Wyss Institute at Harvard University
Sponsor class: OTHER
Collaborators: name: Boston Children's Hospital
name: Deborah Munroe Noonan Memorial Research Fund
First posted: 2013-10-31
Enrollment: 12
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with hemiplegic cerebral palsy or 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.

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

Primary outcomes:
measure: Investigate whether the IOTA can effectively facilitate a participant's ability to perform a specific set of clinically relevant tasks in a clinical setting.
timeFrame: 1 study session per participant, lasting up to 2 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Wyss Institute at Harvard University
name: Leia Stirling, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Children's Hospital
name: Annette Correia, OT
role: PRINCIPAL_INVESTIGATOR
References: