Trials / Completed
CompletedNCT04565639
Hand Assistive Rehabilitation Orthotic Device Effectiveness Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- Liberating Technologies, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 89 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
This study tests the powered hand orthosis device on a small number of participants (up to 6). Research participants with neuromusculoskeletal impairments were recruited for the study and consented with an approved protocol. The study was conducted during 1 visit to LTI in Holliston, MA . The study consists of several assessments. Participants are surveyed for cognitive limitations and self-assessment of difficulties in completing tasks of daily living by completing surveys such as the Quickdash Questionnaire \[1\], the Mini-Mental State test \[2\], and the McGann Feedback form \[3\]. Pinch strength without and with the powered orthosis is evaluated. A selection of functional outcome measures are performed such as the Southampton Hand Assessment Procedure (SHAP) \[4\], the Nine-Hole Peg Test (NHP) \[5\], and the Box and Blocks Test (BBT) \[6\].
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Powered Hand Orthosis | A prototype powered hand orthosis system designed to improve grip strength and improve ability to perform tasks of daily living. |
Timeline
- Start date
- 2019-08-14
- Primary completion
- 2019-11-07
- Completion
- 2019-11-07
- First posted
- 2020-09-25
- Last updated
- 2020-09-25
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04565639. Inclusion in this directory is not an endorsement.