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Hand Assistive Rehabilitation Orthotic Device Effectiveness Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04565639
Recruitment Status : Completed
First Posted : September 25, 2020
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
Liberating Technologies, Inc.

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.

Condition or disease Intervention/treatment Phase
Orthoses Prostheses Device: Powered Hand Orthosis Not Applicable

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].

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Hand Assistive Rehabilitation Orthotic Device Effectiveness Study
Actual Study Start Date : August 14, 2019
Actual Primary Completion Date : November 7, 2019
Actual Study Completion Date : November 7, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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.




Primary Outcome Measures :
  1. Sustained grip strength [ Time Frame: 1 minute ]
    The sustained grip available for achieving activities of daily living that require a sustained grip


Secondary Outcome Measures :
  1. Maximum Grip Strength [ Time Frame: 10 seconds ]
    The maximum strength available for achieving activities of daily living

  2. Accomplishing activities of daily living [ Time Frame: 10 minutes ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04565639


Locations
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United States, Massachusetts
Liberating Technologies, Inc
Holliston, Massachusetts, United States, 01746
Sponsors and Collaborators
Liberating Technologies, Inc.
Investigators
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Principal Investigator: Kevin Keough Liberating Technologies, Inc.
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Responsible Party: Liberating Technologies, Inc.
ClinicalTrials.gov Identifier: NCT04565639    
Other Study ID Numbers: 120190037
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020

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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