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Wearable Device for Motivating Hand Use After Stroke

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ClinicalTrials.gov Identifier: NCT03084705
Recruitment Status : Recruiting
First Posted : March 21, 2017
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
David Reinkensmeyer, University of California, Irvine

Brief Summary:
The goal of this study is to determine the effectiveness of interactive feedback from a wearable device that senses hand function, the Manumeter, in improving upper extremity function in a pilot, randomized controlled trial with chronic stroke patients

Condition or disease Intervention/treatment Phase
Cerebral Stroke Device: Manumeter Not Applicable

Detailed Description:
In this randomized controlled trial, the investigators will compare two groups of chronic stroke participants Group 1 of study participants will use the Manumeter with interactive functions to monitor and motivate upper extremity functional activity. Group 2 of study participants will use the Manumeter but receive no feedback and will be given the current standard-of-care, a booklet describing a home exercise program for increasing upper extremity exercise. The investigators hypothesize that study participants who interactively monitor functional activity with the Manumeter will improve their upper extremity function significantly more.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Interactive, Wearable Device for Measuring and Motivating Hand Use After Stroke
Actual Study Start Date : March 7, 2018
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Arm Intervention/treatment
Experimental: Manumeter with interactive feedback
Study participants will receive an experimental manumeter and interactive feedback from the manumeter to monitor and motivate their upper extremity functional activities.
Device: Manumeter
A manumeter is a first-of-its-kind magnetic sensor to wirelessly detect hand and arm movement in a socially acceptable and easy to don package. The study participants will wear a small magnet as a ring, and a sensing/logging wristband detects changes in the magnetic field as the ring moves; the wristband can detect arm accelerations.

Experimental: Manumeter without interactive feedback
Study participants will receive an experimental manumeter but receive no feedback from the manumeter, and will be given the current standard-of-care for increasing upper extremity exercise booklet to perform at home.
Device: Manumeter
A manumeter is a first-of-its-kind magnetic sensor to wirelessly detect hand and arm movement in a socially acceptable and easy to don package. The study participants will wear a small magnet as a ring, and a sensing/logging wristband detects changes in the magnetic field as the ring moves; the wristband can detect arm accelerations.




Primary Outcome Measures :
  1. Box and Block Test (BBT) [ Time Frame: 3 months ]
    To measure unilateral gross manual dexterity


Secondary Outcome Measures :
  1. Action Research Arm Test (ARAT) [ Time Frame: 3 months ]
    To evaluate specific changes in arm function from handling objects differing in size, weight and shape

  2. Fugl-Meyer Motor Assessment (FM) [ Time Frame: 3 months ]
    To assess motor functioning, balance, joint functioning thru performance based movement

  3. Motor Activity Log (MAL) [ Time Frame: 3 months ]
    To evaluate self-reported functional use of the limb

  4. Amount of upper extremity activity [ Time Frame: 3 months ]
    To evaluate the daily amount of upper extremity activity by using the wearable sensor



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 to 80 years of age
  • Experienced one or multiple strokes at least six months previously
  • Upper Extremity Fugl-Meyer Score < 60 out of 66
  • Absence of moderate to severe upper limb pain (< 3 on the a 10 point visual-analog pain scale)
  • Ability to understand the instructions to operate the device

Exclusion Criteria:

  • 80 years of age and above
  • Implanted pacemaker
  • moderate to severe pain in affected arm
  • severe tone in affected arm as measured on a standard clinical scale
  • language problem that would prevent from properly understanding instructions
  • currently pregnant
  • difficulty in understanding or complying with the instructions given by the experimenter
  • inability to perform the experimental task that will be studied

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): NCT03084705


Contacts
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Contact: Vicky Chan, MSPT 9498248423 vchan2@uci.edu

Locations
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United States, California
University of California, Irvine Recruiting
Irvine, California, United States, 92697
Contact: Vicky Chan, MSPT    949-824-8423    vchan2@uci.edu   
Contact: Diogo Schwerz de Lucena, MS    9498248423    diogo.lucena90@gmail.com   
Sponsors and Collaborators
University of California, Irvine
Investigators
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Principal Investigator: David Reinkensmeyer, PhD University of California, Irvine

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Responsible Party: David Reinkensmeyer, Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT03084705     History of Changes
Other Study ID Numbers: NIH
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases