Trial Outcomes & Findings for Robotic Hand Orthosis Providing Grasp Assistance for Patients With Brachial Plexus Injuries (NCT NCT04939233)
NCT ID: NCT04939233
Last Updated: 2025-10-17
Results Overview
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
COMPLETED
NA
3 participants
The total expected time for the study is about 2 hours.
2025-10-17
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
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Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Exoskeleton Glove
n=3 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=3 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=3 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=3 Participants
|
|
Age, Continuous
|
30 years
STANDARD_DEVIATION 0.82 • n=3 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=3 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Exoskeleton Glove
n=3 Participants
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
|
|---|---|
|
Number of Successful Grasp Trials Per Participant Using Robotic Hand Orthosis
|
13.2 Number of successful grabs of an object
Interval 0.0 to 15.0
|
Adverse Events
Exoskeleton Glove
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Pinhas Ben-Tzvi
Departments of Mechanical Engineering and Electrical and Computer Engineering, Virginia Tech
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place