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

NCT04939233 | Completed Results FDA Device

• 2 other identifiers: 19-3301R21HD095027-01A1
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brachial Plexus Injury

Outcome Measures

Primary Outcomes (1)

• Number of Successful Grasp Trials Per Participant Using Robotic Hand Orthosis

  Southampton Hand Assessment Procedure (SHAP) Construct Measured: Functional hand performance based on prehensile and Activities of Daily Living (ADL) tasks. Structure: 6 Abstract Object Tasks (grip patterns). The five most used grasp types in ADLs were selected for the experiments, which include cylinder grasp, sphere grasp, tip grasp, tripod grasp, and lateral grasp. We selected ten objects that belong to different grasp types for the experiments. Each object was grasped for five times by each participant. Scoring: Successful vs unsuccessful grasps with 10 different objects Interpretation: Successful grasps with 10 different objects

  The total expected time for the study is about 2 hours.

Study Arms (1)

Exoskeleton Glove

EXPERIMENTAL

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

Interventions

Exoskeleton glove DEVICE

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

Exoskeleton Glove

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Carilion Clinic: lead
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Carilion Clinic Institute for Orthopaedics and Neurosciences

Roanoke, Virginia, 24014, United States

Location

Results Point of Contact

• Title: Dr. Pinhas Ben-Tzvi
• Organization: Departments of Mechanical Engineering and Electrical and Computer Engineering, Virginia Tech

bentzvi@vt.edu

NA

Study Officials

• Cesar J Bravo, MD

  Carilion Clinic Ortho Surgeon

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 25, 2021
• Study Start: July 1, 2021
• Primary Completion: May 20, 2022
• Study Completion: February 28, 2023
• Last Updated: October 20, 2025
• Results First Posted: October 20, 2025

Record last verified: 2025-10

Locations

US (1)