Skip to main content
OpenTrials
Completed

NCT Number: NCT02364700

Portable EMG-triggered Hand Robot for Individuals After 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NewYork Presbyterian Hospital-Weill Cornell Medical Center

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of stroke > 6 months ago
  • 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.
  • Intact sensation in the affected hand
  • Full passive range of motion (PROM) in mass flexion and extension of the hand
  • MAS score < 3 for finger flexors and intrinsics
  • MAS score < 3 for finger extensors
  • Visual tracking is intact in all directions
  • Patient must be otherwise medically stable in the opinion of the principal investigator

Exclusion criteria

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

Treatment and study plan

Hand of Hope (HOH)

Device

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)

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. Hand Dynamometry

    Time frame: baseline to 6 weeks (discharge)

    A dynamometer measures grip strength in kilograms

  3. 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

Sponsors and collaborators

Lead sponsor

Rehab-Robotics Company Limited

Industry

Collaborators

  • New York Presbyterian Hospital

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 18, 2015
Registry last updated
Jul 12, 2017

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.