Portable EMG-triggered Hand Robot for Individuals After Stroke

June 13, 2017 updated by: Rehab-Robotics Company Limited

Hand Training Utilizing an Electromyography-triggered Hand Robot for Individuals After Chronic Stroke

This is an interventional pilot study investigating the feasibility of using the hand of hope (HOH) device for individuals with decreased hand function after stroke.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The HOH will be used to provide hand training for patients with decreased hand ability after stroke. The HOH is a light-weight, non-invasive, portable hand robot that provides physical assistance when a patient activates the muscles that open and close the hand. The HOH works by detecting surface EMG muscle activity and therefore requires active participation from the patient throughout the session. Video games linked to the HOH device are specifically designed to work on opening and closing the hand facilitating mass practice and high repetition needed for improving strength and range of motion of muscles.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • NewYork Presbyterian Hospital-Weill Cornell Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Diagnosis of stroke > 6 months ago
  2. Presence of some active range of motion (AROM) in the affected hand, measured by a score of at least 1 on the Box and Block test.
  3. Intact sensation in the affected hand
  4. Full passive range of motion (PROM) in mass flexion and extension of the hand
  5. MAS score < 3 for finger flexors and intrinsics
  6. MAS score < 3 for finger extensors
  7. Visual tracking is intact in all directions
  8. Patient must be otherwise medically stable in the opinion of the principal investigator

Exclusion Criteria:

  1. Patient is receiving active occupational or physical therapy for the affected arm
  2. Patient has joint contractures that prevent proper fit into the HOH device
  3. Patient has other concurrent neurological or orthopedic diagnoses that affect motor ability of the arm such as Parkinson's or Multiple Sclerosis, or arthritis
  4. It has been less than 3 months since last botulinum toxin injection in the affected arm

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: interventional group
This is a single group, interventional pilot study. All participants will receive 6-week hand training on the HOH device.
Device: Hand of Hope (HOH)

Subjects will receive arm training 3x/week for 6 weeks, each session is anticipated to last approximately 60 minutes. Sessions will be scheduled for Monday, Wednesday, and Friday whenever possible to provide a rest period between sessions. Each session will consist of the following:

  • warm up-passive stretch of hand in flexion and extension (5 minutes);
  • setting the EMG threshold parameters for the device;
  • active practicing of opening the hand (Desperate Bee, Hungry Bird, Sun Archer games; 10 min)
  • active practice of closing then hand (UFO Catcher game; 10 min)
  • open and closing the hand (Ball and Basket game; 10 min)
  • open and closing the hand while incorporating reach ( for subjects with adequate ability to reach with shoulder/elbow; 10 min)
  • cool down-passive stretch of hand in flexion and extension (5 minutes)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment of Upper Extremity (FMA)
Time Frame: baseline to 6 weeks (discharge)
The FMA is a performance based evaluation of upper limb impairment of the affected arm after stroke. Scoring is based on an ordinal scale of 0 (no movement) to 2 (normal movement). Scoring is based on sum of 30 items, ranging from 0-60.
baseline to 6 weeks (discharge)
Arm Motor Ability Test (AMAT)
Time Frame: Baseline to 6 weeks (discharge)
The AMAT is performance based measure of functional ability of the affected arm and hand in unilateral and bilateral everyday tasks. It is comprised of 10 functional tasks such as cutting meat with a knife and fork, donning a t-shirt, and phone use with a score ranging from 0 to a maximum of 5 for each item. The total score is the mean score for all individual item scores.
Baseline to 6 weeks (discharge)
Box and Blocks
Time Frame: Baseline to 6 weeks (discharge)
The Box and Blocks is a performance-based functional assessment of hand dexterity ( gross grasp and release). The total score is the number of 2.5cc blocks successfully transferred from one box to another with the affected hand in one minute.
Baseline to 6 weeks (discharge)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke Upper Limb Capacity Scale (SULCS)
Time Frame: Baseline to 6 weeks (discharge)
The SULCs is a performance based measure of upper limb capacity after stroke. Each of the 10 items are administered in a hierarchical order and assigned a score of 0 (unable to complete) or 1 (able to complete the task) with a maximum score of 10.
Baseline to 6 weeks (discharge)
Hand Dynamometry
Time Frame: baseline to 6 weeks (discharge)
A dynamometer measures grip strength in kilograms
baseline to 6 weeks (discharge)
Stroke Impact Scale --Hand Sub Scale (SIS-H)
Time Frame: baseline to 6 weeks (discharge)

The Stroke Impact Scale is a stroke-specific questionnaire evaluating quality of life in stroke survivors over eight domains. Each domain is scored independently on an ordinal scale ranging from 0 (minimum) bto a maximum of 5. Only the Hand sub-score was used in this study. Scores for each domain are transformed and range from 0-100.

Formula for scoring domains:

Transformed Scale = [(Actual raw score - lowest possible raw score) / Possible raw score] * 100
baseline to 6 weeks (discharge)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rehab-Robotics Company Limited

Collaborators

New York Presbyterian Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

February 5, 2015

First Submitted That Met QC Criteria

February 10, 2015

First Posted (ESTIMATE)

February 18, 2015

Study Record Updates

Last Update Posted (ACTUAL)

July 12, 2017

Last Update Submitted That Met QC Criteria

June 13, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1409015458

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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