Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R21HD095027-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Cesar J Bravo, MD | Carilion Clinic Ortho Surgeon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carilion Clinic Institute for Orthopaedics and Neurosciences | Roanoke | Virginia | 24014 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Full Range | Number of successful grabs of an object | The total expected time for the study is about 2 hours. |
|
1 day
The only potential risk is slight discomfort while wearing the device. The device itself will be designed such that it cannot violate normal human ranges of motion in the hand and is free of potential pinch points. Furthermore, the devices motion can be immediately stopped if necessary.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Pinhas Ben-Tzvi | Departments of Mechanical Engineering and Electrical and Computer Engineering, Virginia Tech | NA | bentzvi@vt.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 29, 2019 | Aug 25, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 17, 2022 | Jan 3, 2024 | ICF_001.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
Not provided
Not provided