search
Back to results

Wearable Device for Motivating Hand Use After Stroke

Primary Purpose

Cerebral Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Manumeter
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, Irvine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Manumeter with interactive feedback

Manumeter without interactive feedback

Arm Description

Study participants will receive an experimental manumeter and interactive feedback from the manumeter to monitor and motivate their upper extremity functional activities.

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.

Outcomes

Primary Outcome Measures

Box and Blocks Test (BBT)
To measure unilateral gross manual dexterity

Secondary Outcome Measures

Action Research Arm Test (ARAT)
To evaluate specific changes in arm function from handling objects differing in size, weight and shape
Fugl-Meyer Motor Assessment (FM)
To assess motor functioning, balance, joint functioning thru performance based movement
Motor Activity Log (MAL)
To evaluate self-reported functional use of the limb
Amount of upper extremity activity
To evaluate the daily amount of upper extremity activity by using the wearable sensor

Full Information

First Posted
March 14, 2017
Last Updated
March 24, 2021
Sponsor
University of California, Irvine
search

1. Study Identification

Unique Protocol Identification Number
NCT03084705
Brief Title
Wearable Device for Motivating Hand Use After Stroke
Official Title
An Interactive, Wearable Device for Measuring and Motivating Hand Use After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 7, 2018 (Actual)
Primary Completion Date
August 19, 2019 (Actual)
Study Completion Date
January 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manumeter with interactive feedback
Arm Type
Experimental
Arm Description
Study participants will receive an experimental manumeter and interactive feedback from the manumeter to monitor and motivate their upper extremity functional activities.
Arm Title
Manumeter without interactive feedback
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Manumeter
Intervention Description
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 Measure Information:
Title
Box and Blocks Test (BBT)
Description
To measure unilateral gross manual dexterity
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Action Research Arm Test (ARAT)
Description
To evaluate specific changes in arm function from handling objects differing in size, weight and shape
Time Frame
3 months
Title
Fugl-Meyer Motor Assessment (FM)
Description
To assess motor functioning, balance, joint functioning thru performance based movement
Time Frame
3 months
Title
Motor Activity Log (MAL)
Description
To evaluate self-reported functional use of the limb
Time Frame
3 months
Title
Amount of upper extremity activity
Description
To evaluate the daily amount of upper extremity activity by using the wearable sensor
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Reinkensmeyer, PhD
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Wearable Device for Motivating Hand Use After Stroke

We'll reach out to this number within 24 hrs