Brachial Plexus InjuryNCT04939233
Robotic Hand Orthosis Providing Grasp Assistance for Patients With Brachial Plexus Injuries
A study testing Exoskeleton glove in people with Brachial Plexus Injury, run by Carilion Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Brachial Plexus Injury
- What is being tested?
- Exoskeleton glove
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Brachial plexus injury to the right upper extremity
- 18 - 69 y/o with pan plexus injuries
- Lower root injuries (C7, C8, T1)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Carilion Clinic Institute for Orthopaedics and Neurosciences
Roanoke, Virginia, 24014
About this study
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.
Read the 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.
- Conditions
- Brachial Plexus Injury
- Being tested
- Exoskeleton glove
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exoskeleton gloveDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Exoskeleton glove |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The total expected time for the study is about 2 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start1 Jul 2021
- Primary completion20 May 2022
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Brachial Plexus InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carilion Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Cesar J Bravo, MD, Principal investigator, Carilion Clinic Ortho Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04939233
- Sponsor's protocol ID
- 19-330
- Other IDs
- 1R21HD095027-01A1
- Status last verified
- Oct 2025
- First submitted
- 28 May 2021
- Last updated
- 20 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Hand Orthosis Providing Grasp Assistance for Patients With Brachial Plexus Injuries
- ClinicalTrials.gov ID
- NCT04939233
- Acronym / sponsor ID
- 19-330
- Conditions
- Brachial Plexus Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Carilion ClinicUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 25 Jun 2021 (actual)
- Results
- Posted 20 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exoskeleton Glove | Experimental | Device: Exoskeleton glovePerform 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. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Brachial plexus injury to the right upper extremity
- 18 - 69 y/o with pan plexus injuries
- Lower root injuries (C7, C8, T1)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exoskeleton gloveA 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 | Device | Exoskeleton Glove |
Primary outcome
Number of Successful Grasp Trials Per Participant Using Robotic Hand Orthosis
Time frame: The total expected time for the study is about 2 hours.
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cesar J Bravo, MD principal investigator
Carilion Clinic Ortho Surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exoskeleton glove in people with Brachial Plexus Injury, run by Carilion Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Successful Grasp Trials Per Participant Using Robotic Hand Orthosis (time frame: The total expected time for the study is about 2 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.