Brachial Plexus Injury Clinical Trial
Official title:
Robotic Hand Orthosis Providing Grasp Assistance for Patients With Brachial Plexus Injuries
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.
Status | Recruiting |
Enrollment | 6 |
Est. completion date | July 15, 2022 |
Est. primary completion date | July 15, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 69 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Carilion Clinic Institute for Orthopaedics and Neurosciences | Roanoke | Virginia |
Lead Sponsor | Collaborator |
---|---|
Carilion Clinic | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | First hour. The total expected time for the study is about 2 hours. | |
Primary | 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. | First hour. The total expected time for the study is about 2 hours. | |
Primary | 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: | Second hour. The total expected time for the study is about 2 hours. | |
Primary | 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. | Second hour. The total expected time for the study is about 2 hours. |
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