Hand Assistive Rehabilitation Orthotic Device Effectiveness Study

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.

Study Overview

• Status: Completed
• Conditions: Orthoses; Prostheses
• Intervention / Treatment: Device: Powered Hand Orthosis

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].

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Holliston, Massachusetts, United States, 01746
      • Liberating Technologies, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Power Hand Orthosis; Participants will test the improved grip strength using the powered hand orthosis system.	Device: Powered Hand Orthosis; A prototype powered hand orthosis system designed to improve grip strength and improve ability to perform tasks of daily living.
Experimental: Experimental Power Hand Orthosis - Tasks of Daily Living; Participants will test the improved ability to perform tasks of daily living using the powered hand orthosis system.	Device: Powered Hand Orthosis; A prototype powered hand orthosis system designed to improve grip strength and improve ability to perform tasks of daily living.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sustained grip strength	The sustained grip available for achieving activities of daily living that require a sustained grip	1 minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Grip Strength	The maximum strength available for achieving activities of daily living	10 seconds
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

Collaborators and Investigators

• Sponsor: Liberating Technologies, Inc.
• Investigators: Principal Investigator: Kevin Keough, Liberating Technologies, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2019
• Primary Completion (Actual): November 7, 2019
• Study Completion (Actual): November 7, 2019

Study Registration Dates

• First Submitted: August 31, 2020
• First Submitted That Met QC Criteria: September 22, 2020
• First Posted (Actual): September 25, 2020

Study Record Updates

• Last Update Posted (Actual): September 25, 2020
• Last Update Submitted That Met QC Criteria: September 22, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 120190037

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No