Evaluating Human-Machine Interfaces in a Robotic Thumb Orthosis

NCT01973426 | Completed

• 1 other identifier: AMD-CS-0026
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiplegic Stroke; Hemiplegic Cerebral Palsy

Keywords

Robot; Thumb; Orthosis; Hemiplegia; Hemiplegic Stroke; Hemiplegic Cerebral Palsy; Stroke; Cerebral Palsy; Grasp assistance

Outcome Measures

Primary Outcomes (1)

• Investigate whether the IOTA can effectively facilitate a participant's ability to perform a specific set of clinically relevant tasks in a clinical setting.

  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).

  1 study session per participant, lasting up to 2 hours.

Study Arms (1)

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)

Interventions

Isolated Orthosis for Thumb Actuation (IOTA) DEVICE

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.

Children with limited control of their thumb

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with hemiplegic cerebral palsy or hemiplegic stroke.

You may qualify if:

• 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

Sponsors & Collaborators

• Wyss Institute at Harvard University: lead
• Boston Children's Hospital: collaborator
• Deborah Munroe Noonan Memorial Research Fund: collaborator

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Hemiplegia; Stroke; Cerebral Palsy

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Damage, Chronic

Study Officials

• Leia Stirling, Ph.D.

  Wyss Institute at Harvard University

  PRINCIPAL INVESTIGATOR

• Annette Correia, OT

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2013
• First Posted: October 31, 2013
• Study Start: October 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: November 1, 2017
• Last Updated: June 9, 2020

Record last verified: 2020-06

Locations

US (1)