Hand Assistive Rehabilitation Orthotic Device Effectiveness Study

NCT04565639 | Completed FDA Device

• 1 other identifier: 120190037
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthoses; Prostheses

Outcome Measures

Primary Outcomes (1)

• Sustained grip strength

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

  1 minute

Secondary Outcomes (2)

• Maximum Grip Strength

  10 seconds

• Accomplishing activities of daily living

  10 minutes

Study Arms (2)

Experimental Power Hand Orthosis

EXPERIMENTAL

Participants will test the improved grip strength using the powered hand orthosis system.

Device: Powered Hand Orthosis

Experimental Power Hand Orthosis - Tasks of Daily Living

EXPERIMENTAL

Participants will test the improved ability to perform tasks of daily living using the powered hand orthosis system.

Device: Powered Hand Orthosis

Interventions

Powered Hand Orthosis DEVICE

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

Experimental Power Hand Orthosis; Experimental Power Hand Orthosis - Tasks of Daily Living

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Liberating Technologies, Inc.: lead

Study Sites (1)

Liberating Technologies, Inc

Holliston, Massachusetts, 01746, United States

Location

Study Officials

• Kevin Keough

  Liberating Technologies, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 25, 2020
• Study Start: August 14, 2019
• Primary Completion: November 7, 2019
• Study Completion: November 7, 2019
• Last Updated: September 25, 2020

Record last verified: 2020-09

Locations

US (1)