Hand Assistive Rehabilitation Orthotic Device Effectiveness Study

Liberating Technologies

Status

Completed

Conditions

Prostheses

Orthoses

Treatments

Device: Powered Hand Orthosis

Study type

Interventional

Funder types

Industry

Identifiers

NCT04565639

120190037

Details and patient eligibility

About

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.

Full 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].

Enrollment

3 patients

Sex

All

Ages

18 to 89 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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