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Completed

NCT Number: NCT03084705

Wearable Device for Motivating Hand Use After Stroke

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

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Irvine

Irvine, California, 92697, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Manumeter

Device

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 outcomes

  1. Box and Blocks Test (BBT)

    Time frame: 3 months

    To measure unilateral gross manual dexterity

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Official study title

An Interactive, Wearable Device for Measuring and Motivating Hand Use After Stroke

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Mar 21, 2017
Registry last updated
Mar 29, 2021

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.

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