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MyHand: An Active Hand Orthosis for Stroke Patients

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ClinicalTrials.gov Identifier: NCT03767894
Recruitment Status : Completed
First Posted : December 7, 2018
Last Update Posted : August 22, 2019
Sponsor:
Collaborators:
Wallace H. Coulter Foundation
U.S. National Science Foundation
Information provided by (Responsible Party):
Joel Stein, MD, Columbia University

Brief Summary:
This study seeks to explore the efficacy of several control mechanisms for the device and the impact of a device training program on its utility as a neuroprosthetic and training tool for upper limb recovery.

Condition or disease Intervention/treatment Phase
Stroke Device: EMG Band Device: Shoulder harness Not Applicable

Detailed Description:
Hand rehabilitation through occupational therapy is critical for many stroke survivors, but it is also greatly limited by insurance coverage, shortage of therapists, and logistic constraints. To address this, stroke patients need a rehabilitation method they can use on their own, without direct clinical supervision, and for activities of daily living. MyHand is a wearable and active hand orthosis consisting of a glove and forearm splint, equipped with actuators and tendons which connect to the fingers.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Subjects are assessed by an independent therapist. The therapist is not blinded to the control mechanism used during treatment.
Primary Purpose: Treatment
Official Title: MyHand: An Active Hand Orthosis for Stroke Patients
Actual Study Start Date : November 13, 2017
Actual Primary Completion Date : June 27, 2019
Actual Study Completion Date : June 27, 2019

Arm Intervention/treatment
Experimental: MyHand orthosis
Subjects are trained to control and use the MyHand orthosis either with a shoulder harness or an EMG band. The MyHand orthosis aims to aid in fine motor skills such as picking up and holding items of varying shape, size and weight.
Device: EMG Band
The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear an EMG band to control and activate the MyHand orthosis.

Device: Shoulder harness
The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear a shoulder strap to control and activate the MyHand orthosis, either with shoulder elevation or shoulder depression.




Primary Outcome Measures :
  1. Score on Action Research Arm Test (ARAT) [ Time Frame: 4 Weeks ]
    The ARAT is a 19-item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from 0 indicating cannot perform to 3, indicating performs test normally. Scores on the ARAT may range from 0-57 points, with a maximum score of 57 points indicating better performance.

  2. Score on the Upper Extremity Component of the Fugl-Meyer Scale (UEFM) [ Time Frame: 4 Weeks ]
    The UEFM evaluates and measures recovery in post-stroke hemiplegic patients. There are a total of 5 domains, and each item is scored on a 3-point ordinal scale, with 0 indicating cannot perform to 3, indicating performs fully. The maximum score for all 5 domains is 226, with a higher score indicating better performance.


Secondary Outcome Measures :
  1. Score on Modified Ashworth Scale (MAS) [ Time Frame: 4 Weeks ]
    The Ashworth or Modified Ashworth Scale (MAS) is a measure of spasticity developed as a simple clinical classification to assess the anti-spastic effects of carisoprodol in multiple sclerosis. It is rated on a 5-point nominal scale using subjective clinical assessments of tone ranging from 0 - 'no increases in tone' to 4 - 'limb rigid in flexion or extension [abduction/adduction]'.

  2. Score on Box and Blocks Test (BBT) [ Time Frame: 4 Weeks ]
    The BBT measures unilateral gross manual dexterity. Individuals are scored based on the number of blocks transferred from one compartment to the other compartment in 60 seconds and each hand is scored separately. Higher scores are indicative of better manual dexterity.

  3. Treatment Adherence Rate [ Time Frame: 4 Weeks ]
    This rate will be measured by patient attendance/ability to complete full treatment protocol

  4. Total Number of Adverse Events During Intervention [ Time Frame: 4 Weeks ]
    All adverse events will be tracking during the course of the intervention.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects over 18 years of age
  • History of stroke resulting in significant upper limb impairment
  • Full passive range of motion
  • Gross control of the proximal upper extremity
  • Lacks timely grasp/release
  • No more than moderate flexor tone
  • Intact cognition

Exclusion criteria include:

  • Other Neurological/orthopedic disorders
  • Excessive spasticity/contracture

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03767894


Locations
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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Wallace H. Coulter Foundation
U.S. National Science Foundation
Investigators
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Principal Investigator: Joel Stein, MD Columbia University

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Responsible Party: Joel Stein, MD, Simon Baruch Professor of Physical Medicine and Rehabilitation, Columbia University
ClinicalTrials.gov Identifier: NCT03767894     History of Changes
Other Study ID Numbers: AAAP8752
IIS-1526960 ( Other Grant/Funding Number: National Science Foundation )
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Joel Stein, MD, Columbia University:
Hand orthosis
Stroke
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases