Hand Assistive Rehabilitation Orthotic Device Effectiveness Study

Prostheses Clinical Trial

Official title:

Hand Assistive Rehabilitation Orthotic Device Effectiveness Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04565639
• Other study ID #: 120190037
• Status: Completed
• Phase: N/A
• Start date: August 14, 2019
• Est. completion date: November 7, 2019

Study information

• Verified date: September 2020
• Source: Liberating Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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].

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Orthoses
• Prostheses

Intervention

Device:
• Powered Hand Orthosis
A prototype powered hand orthosis system designed to improve grip strength and improve ability to perform tasks of daily living.

Locations

Country	Name	City	State
United States	Liberating Technologies, Inc	Holliston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Liberating Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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