Prostheses Clinical Trial
Official title:
Hand Assistive Rehabilitation Orthotic Device Effectiveness Study
Verified date | September 2020 |
Source | Liberating Technologies, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objective of this study is to evaluate pinch strength improvements and improvements in coordination and functional ability. Pinch strength measurements are made on subjects both with and without the device to evaluate the potential improvements. Also, coordination and functional testing is performed both with and without the device to compare performance under both conditions and evaluate potential improvement.
Status | Completed |
Enrollment | 3 |
Est. completion date | November 7, 2019 |
Est. primary completion date | November 7, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 89 Years |
Eligibility |
Participants in this study must meet the following inclusion/exclusion criteria. - Subjects diagnosed with one of these conditions- ALS, brachial plexus injuries, CVA hemiplegia, multiple sclerosis, muscular dystrophy, spinal cord injury, and traumatic brain injury - Range of motion (ROM) and strength characterized by one of the following limitations: - Range of motion within functional limits (as determined by our OT consultant Deb Latour), but with limited pinch strength measured by a pinch meter of less than 2 pounds or manual muscle test grade of 3. - Limited range of motion of the wrist, thumb, index, and middle fingers as determined by a clinical occupational therapist - Passive ROM within functional limits as determined by our OT consultant Deb Latour - No tremors in the hand or arm - Must be able to understand and follow up to 3 step directions for testing - No other comorbidities that may affect their ability to use the device - Modified Ashworth Scale assessment for spasticity of less than 2 - Greater than 18 years old - Must be able to wear a powered hand orthosis device. - Be able to make the required visit(s) to LTI for testing - Mini-mental test [2] score greater than 18 |
Country | Name | City | State |
---|---|---|---|
United States | Liberating Technologies, Inc | Holliston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Liberating Technologies, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sustained grip strength | The sustained grip available for achieving activities of daily living that require a sustained grip | 1 minute | |
Secondary | Maximum Grip Strength | The maximum strength available for achieving activities of daily living | 10 seconds | |
Secondary | Accomplishing activities of daily living | Subjects were tested to accomplish a number of activities of daily living both with and without the device. Initial activities included the SHAP protocol and other activities that were identified by our occupational therapist consultant as relevant to the device. | 10 minutes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
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N/A |