Wearable Device for Motivating Hand Use After Stroke

NCT ID: NCT03084705

Last Updated: 2021-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-07
• Study Completion Date: 2020-01-13

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.

Conditions

Cerebral Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Manumeter

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Manumeter

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

David Reinkensmeyer

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Reinkensmeyer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

University of California, Irvine

Irvine, California, United States

Countries

United States

Other Identifiers

NIH HS# 2017-4119

Identifier Type: -

Identifier Source: org_study_id