Robotic Hand Orthosis Providing Grasp Assistance for Patients With Brachial Plexus Injuries
Primary Purpose
Brachial Plexus Injury
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exoskeleton glove
Sponsored by
About this trial
This is an interventional device feasibility trial for Brachial Plexus Injury
Eligibility Criteria
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
Sites / Locations
- Carilion Clinic Institute for Orthopaedics and NeurosciencesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Exoskeleton Glove
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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:
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04939233
First Posted
May 28, 2021
Last Updated
April 7, 2022
Sponsor
Carilion Clinic
Collaborators
National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT04939233
Brief Title
Robotic Hand Orthosis Providing Grasp Assistance for Patients With Brachial Plexus Injuries
Official Title
Robotic Hand Orthosis Providing Grasp Assistance for Patients With Brachial Plexus Injuries
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
July 15, 2022 (Anticipated)
Study Completion Date
July 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carilion Clinic
Collaborators
National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brachial Plexus Injury
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exoskeleton Glove
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Exoskeleton glove
Intervention Description
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
Primary Outcome Measure Information:
Title
SHAP (without device)
Description
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.
Time Frame
First hour. The total expected time for the study is about 2 hours.
Title
QuickDASH (without device)
Description
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.
Time Frame
First hour. The total expected time for the study is about 2 hours.
Title
SHAP (with device)
Description
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:
Time Frame
Second hour. The total expected time for the study is about 2 hours.
Title
QuickDASH (with device)
Description
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.
Time Frame
Second hour. The total expected time for the study is about 2 hours.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cesar J. Bravo, MD
Phone
5405211887
Email
cjbravo@carilionclinic.org
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea A. Yu-Shan, BS
Phone
5405884188
Email
aayushanchevez@carilionclinic.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cesar J Bravo, MD
Organizational Affiliation
Carilion Clinic Ortho Surgeon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carilion Clinic Institute for Orthopaedics and Neurosciences
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cesar J Bravo, MD
Phone
540-521-1887
Email
cjbravo@carilionclinic.org
12. IPD Sharing Statement
Learn more about this trial
Robotic Hand Orthosis Providing Grasp Assistance for Patients With Brachial Plexus Injuries
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