Robotic Hand Orthosis Providing Grasp Assistance for Patients With Brachial Plexus Injuries

The proposed research, the development of an innovative robotic hand orthosis with intelligent grasping control, is relevant to public health as it will restore a large measure of functionality to the paralyzed hand of a person who has suffered a brachial plexus injury. The proposed orthosis will utilize novel technology that will result in a device that is compact, portable, dexterous, and intuitively controllable while overcoming the disadvantages of previously developed orthoses that rendered them difficult to use. The restoration of functionality to ones hands will significantly improve their quality of life as well as their ability to again participate in the workforce and complete dexterous activities in their daily lives.

Study Overview

• Status: Recruiting
• Conditions: Brachial Plexus Injury
• Intervention / Treatment: Device: Exoskeleton glove

Detailed Description

The overall objective of this research is to design, fabricate, integrate, and test a lightweight and portable robotic hand orthosis intended to restore hand functionality through fully controllable individual finger actuation. This objective is based on the hypothesis that use of such a robotic hand orthosis will result in significant improvement of hand ability for adults with brachial plexus injury, as evaluated through the Southampton Hand Assessment Procedure (SHAP).

To achieve this, several novel design aspects are incorporated. The use of miniature linear actuators and lightweight materials allows for the motors and sensors to all mount atop the dorsum of the hand, and eliminate the need for bulky external actuation units. In addition, the actuators have inbuilt force sensing capabilities to provide feedback on the force being applied to each individual finger, even before contact is made with a grasped object. Furthermore, wrist flexion/extension is powered, resulting in a more realistic grasping paradigm than is commonly found in robotic orthoses. Moreover, an intuitive control system will be designed in order to fully capitalize on the controllability of each finger, allowing for varied grasp geometries and motions.

A summary of the specific aims of this study are:

Design and prototype the robotic hand orthosis with the goal of creating a uniquely dexterous, lightweight and portable device. In addition, the control methodologies required to exploit the full capabilities of the orthosis will be designed. This will result in the development of an experimental research platform to determine the viability of the design and hypothesis.

Perform a feasibility trial of the robotic orthosis device by providing it to a small cohort of adult patients suffering from paralysis due to a brachial plexus injury. The patients will be assessed via the SHAP, and their respective scores both with and without the orthosis will be evaluated to determine their level of improvement in dexterity and function.

• Study Type: Interventional
• Enrollment (Anticipated): 6
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cesar J. Bravo, MD; Phone Number: 5405211887; Email: cjbravo@carilionclinic.org
• Study Contact Backup: Name: Andrea A. Yu-Shan, BS; Phone Number: 5405884188; Email: aayushanchevez@carilionclinic.org

Study Locations

• United States
  • Virginia
    • Roanoke, Virginia, United States, 24014
      • Recruiting
      • Carilion Clinic Institute for Orthopaedics and Neurosciences
      • Contact: Cesar J Bravo, MD; Phone Number: 540-521-1887; Email: cjbravo@carilionclinic.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Brachial plexus injury to the right upper extremity
• 18 - 69 y/o with pan plexus injuries
• Lower root injuries (C7, C8, T1)

Exclusion Criteria:

• No significant hand/wrist contractures or associated deformities which would affect participation
• No open wounds in affected hand or wrist
• Able to provide consent for treatment and follow general directions
• Only right-hand involved individuals will be considered, as the orthosis prototypes will be designed for right hand use only at this stage of the research

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exoskeleton Glove; Perform a feasibility trial of the robotic orthosis device by providing it to a small cohort of adult patients suffering from paralysis due to a brachial plexus injury.	Device: Exoskeleton glove; A robotic hand orthosis (exoskeleton glove) will have been developed that is able to naturalistically bend the finger joints of the individuals based on intuitive voice commands

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SHAP (without device)	The Southampton Hand Assessment Procedure (SHAP) has been formed based on the analysis of grip patterns, and their frequency of use in Activities of Daily Living (ADL) tasks.	First hour. The total expected time for the study is about 2 hours.
QuickDASH (without device)	The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30- item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale. The QuickDASH is an abbreviated version of the original DASH outcome measure in comparison to the original 30 item DASH outcome measure, the QuickDASH only contains 11 items. It is a questionnaire that measures an individual's ability to complete tasks, absorb forces, and severity of symptoms.	First hour. The total expected time for the study is about 2 hours.
SHAP (with device)	The Southampton Hand Assessment Procedure (SHAP) has been formed based on the analysis of grip patterns, and their frequency of use in Activities of Daily Living (ADL) tasks. Details of the SHAP are as follows:	Second hour. The total expected time for the study is about 2 hours.
QuickDASH (with device)	The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30- item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale. The QuickDASH is an abbreviated version of the original DASH outcome measure in comparison to the original 30 item DASH outcome measure, the QuickDASH only contains 11 items. It is a questionnaire that measures an individual's ability to complete tasks, absorb forces, and severity of symptoms.	Second hour. The total expected time for the study is about 2 hours.

Collaborators and Investigators

• Sponsor: Carilion Clinic
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Cesar J Bravo, MD, Carilion Clinic Ortho Surgeon

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Anticipated): July 15, 2022
• Study Completion (Anticipated): July 15, 2022

Study Registration Dates

• First Submitted: May 28, 2021
• First Submitted That Met QC Criteria: June 17, 2021
• First Posted (Actual): June 25, 2021

Study Record Updates

• Last Update Posted (Actual): April 11, 2022
• Last Update Submitted That Met QC Criteria: April 7, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 19-330; 1R21HD095027-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes