Clinical trial NCT04565639: Hand Assistive Rehabilitation Orthotic Device Effectiveness Study
Official title: Hand Assistive Rehabilitation Orthotic Device Effectiveness Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthoses
Prostheses
Lead sponsor: Liberating Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2020-09-25
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief 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) \[6\].

Eligibility 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

Primary outcomes:
measure: Sustained grip strength
timeFrame: 1 minute
Secondary outcomes:
measure: Maximum Grip Strength
timeFrame: 10 seconds
measure: Accomplishing activities of daily living
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Holliston
country: United States
facility: Liberating Technologies, Inc
state: Massachusetts
Study officials:
affiliation: Liberating Technologies, Inc.
name: Kevin Keough
role: PRINCIPAL_INVESTIGATOR
References: