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StrokeNCT02364700

Portable EMG-triggered Hand Robot for Individuals After Stroke

A study testing Hand of Hope (HOH) in people with Stroke, run by Rehab-Robotics Company Limited at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
Hand of Hope (HOH)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
Mar 2015to Jun 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • NewYork Presbyterian Hospital-Weill Cornell Medical Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Stroke
Being tested
Hand of Hope (HOH)
Keywords
stroke, robotics, hand rehabilitation
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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)
Study groups in NCT02364700
Study groupRoleWhat they receive
interventional groupExperimentalThis is a single group, interventional pilot study. All participants will receive 6-week hand training on the HOH device.
Receives: Device: Hand of Hope (HOH)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fugl-Meyer Assessment of Upper Extremity (FMA)

    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.

    Measured: baseline to 6 weeks (discharge)

  2. Arm Motor Ability Test (AMAT)

    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.

    Measured: Baseline to 6 weeks (discharge)

  3. Box and Blocks

    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.

    Measured: Baseline to 6 weeks (discharge)

Secondary outcomes (3)

  1. Stroke Upper Limb Capacity Scale (SULCS)

    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.

    Measured: Baseline to 6 weeks (discharge)

  2. Hand Dynamometry

    A dynamometer measures grip strength in kilograms

    Measured: baseline to 6 weeks (discharge)

  3. Stroke Impact Scale --Hand Sub Scale (SIS-H)

    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

    Measured: baseline to 6 weeks (discharge)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02364700
Sponsor's protocol ID
1409015458
Status last verified
Jun 2017
First submitted
5 Feb 2015
Last updated
12 Jul 2017
Data monitoring committee
No

Publications

  • O'Dell MW, Lin CC, Harrison V. Stroke rehabilitation: strategies to enhance motor recovery. Annu Rev Med. 2009;60:55-68. doi: 10.1146/annurev.med.60.042707.104248.

    PubMed 18928333

  • Tong KY, Ho SK, Pang PK, Hu XL, Tam WK, Fung KL, Wei XJ, Chen PN, Chen M. An intention driven hand functions task training robotic system. Annu Int Conf IEEE Eng Med Biol Soc. 2010;2010:3406-9. doi: 10.1109/IEMBS.2010.5627930.

    PubMed 21097247

  • Ho NS, Tong KY, Hu XL, Fung KL, Wei XJ, Rong W, Susanto EA. An EMG-driven exoskeleton hand robotic training device on chronic stroke subjects: task training system for stroke rehabilitation. IEEE Int Conf Rehabil Robot. 2011;2011:5975340. doi: 10.1109/ICORR.2011.5975340.

    PubMed 22275545

  • Hu XL, Tong KY, Wei XJ, Rong W, Susanto EA, Ho SK. The effects of post-stroke upper-limb training with an electromyography (EMG)-driven hand robot. J Electromyogr Kinesiol. 2013 Oct;23(5):1065-74. doi: 10.1016/j.jelekin.2013.07.007. Epub 2013 Aug 7.

    PubMed 23932795

  • Kwakkel G, Kollen BJ, van der Grond J, Prevo AJ. Probability of regaining dexterity in the flaccid upper limb: impact of severity of paresis and time since onset in acute stroke. Stroke. 2003 Sep;34(9):2181-6. doi: 10.1161/01.STR.0000087172.16305.CD. Epub 2003 Aug 7.

    PubMed 12907818

Questions about this trial

What is this clinical trial studying?

A study testing Hand of Hope (HOH) in people with Stroke, run by Rehab-Robotics Company Limited at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fugl-Meyer Assessment of Upper Extremity (FMA) (time frame: baseline to 6 weeks (discharge)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02364700, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2017.

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