Wearable Device for Motivating Hand Use After Stroke

University of California Irvine (UCI)

Status: Completed

Conditions: Cerebral Stroke

Treatments: Device: Manumeter

Study type: Interventional

Funder types: Other

Identifiers

NCT03084705

NIH HS# 2017-4119

Details and patient eligibility

About

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

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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17 participants in 2 patient groups

Manumeter with interactive feedback

Experimental group

Description:

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

Treatment:

Device: Manumeter

Manumeter without interactive feedback

Experimental group

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.

Treatment:

Device: Manumeter