Hand Assistive Rehabilitation Orthotic Device Effectiveness Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-14

Study Completion Date

2019-11-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Assessing Force Feedback With the SoftHand Pro

NCT03412656

Amputation, Traumatic Limb Defect

COMPLETED NA

Investigation of Factors Affecting Upper Extremity Function in Healthy Young Adults

NCT06937879

Function

COMPLETED

The Effect of Activity-based Training in Patients With Hand-related Injuries Grouped Using Sense of Coherence Scores

NCT02098564

Hand Related Injuries

COMPLETED NA

Evaluation of a Non-invasive Sensory Feedback System in Hand Prostheses

NCT03876405

Amputation, Traumatic Prosthesis User

COMPLETED NA

Synchronous Tele-Resistance Training to Improve Upper Extremity Function in Patients With Spinal Cord Injury

NCT07115693

Spinal Cord Injury

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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) \[6\].

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Orthoses Prostheses

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental Power Hand Orthosis

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

Group Type EXPERIMENTAL

Powered Hand Orthosis

Intervention Type 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 - Tasks of Daily Living

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

Group Type EXPERIMENTAL

Powered Hand Orthosis

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Powered Hand Orthosis

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes