Hand Assistive Rehabilitation Orthotic Device Effectiveness Study

Not Applicable

Completed

• Conditions: Orthoses; Prostheses
• Interventions: Device: Powered Hand Orthosis

• Registration Number: NCT04565639
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2019-08-14
• Primary Completion: 2019-11-07
• Study Completion: 2019-11-07
• Study First Submitted: 2020-08-31
• Status Verified: 2020-09
• Study First Submitted QC: 2020-09-22
• Last Update Submitted: 2020-09-22
• Study First Posted: 2020-09-25
• Last Update Posted: 2020-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental Power Hand Orthosis	Powered Hand Orthosis	Participants will test the improved grip strength using the powered hand orthosis system.
Experimental Power Hand Orthosis - Tasks of Daily Living	Powered Hand Orthosis	Participants will test the improved ability to perform tasks of daily living using the powered hand orthosis system.

Primary Outcome Measures

Name	Time	Method
Sustained grip strength	1 minute	The sustained grip available for achieving activities of daily living that require a sustained grip

Secondary Outcome Measures

Name	Time	Method
Maximum Grip Strength	10 seconds	The maximum strength available for achieving activities of daily living
Accomplishing activities of daily living	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.

Trial Locations

Locations (1)

Liberating Technologies, Inc; 🇺🇸 Holliston, Massachusetts, United States