Wearable Device for Motivating Hand Use After Stroke

Cerebral Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03084705
• Other study ID #: NIH HS# 2017-4119
• Status: Completed
• Phase: N/A
• Start date: March 7, 2018
• Est. completion date: January 13, 2020

Study information

• Verified date: March 2021
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: January 13, 2020
• Est. primary completion date: August 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Stroke
• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	University of California, Irvine	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Box and Blocks Test (BBT)	To measure unilateral gross manual dexterity	3 months
Secondary	Action Research Arm Test (ARAT)	To evaluate specific changes in arm function from handling objects differing in size, weight and shape	3 months
Secondary	Fugl-Meyer Motor Assessment (FM)	To assess motor functioning, balance, joint functioning thru performance based movement	3 months
Secondary	Motor Activity Log (MAL)	To evaluate self-reported functional use of the limb	3 months
Secondary	Amount of upper extremity activity	To evaluate the daily amount of upper extremity activity by using the wearable sensor	3 months