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Completed

NCT Number: NCT04565639

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.

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Key information

Conditions

Orthoses Prostheses

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Liberating Technologies, Inc

Holliston, Massachusetts, 01746, United States

About this study

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].

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Powered Hand Orthosis

Device

A prototype powered hand orthosis system designed to improve grip strength and improve ability to perform tasks of daily living.

Primary outcomes

  1. Sustained grip strength

    Time frame: 1 minute

    The sustained grip available for achieving activities of daily living that require a sustained grip

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Liberating Technologies, Inc.

Industry

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 25, 2020
Registry last updated
Sep 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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