Wearable Device for Motivating Hand Use After Stroke

Not Applicable

Completed

• Conditions: Cerebral Stroke
• Interventions: Device: Manumeter

• Registration Number: NCT03084705
• Lead Sponsor: University of California, Irvine

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.

Study Timeline

• Study First Submitted: 2017-03-14
• Study First Submitted QC: 2017-03-14
• Study First Posted: 2017-03-21
• Study Start: 2018-03-07
• Primary Completion: 2019-08-19
• Study Completion: 2020-01-13
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-24
• Last Update Posted: 2021-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manumeter without interactive feedback	Manumeter	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.
Manumeter with interactive feedback	Manumeter	Study participants will receive an experimental manumeter and interactive feedback from the manumeter to monitor and motivate their upper extremity functional activities.

Primary Outcome Measures

Name	Time	Method
Box and Blocks Test (BBT)	3 months	To measure unilateral gross manual dexterity

Secondary Outcome Measures

Name	Time	Method
Fugl-Meyer Motor Assessment (FM)	3 months	To assess motor functioning, balance, joint functioning thru performance based movement
Amount of upper extremity activity	3 months	To evaluate the daily amount of upper extremity activity by using the wearable sensor
Motor Activity Log (MAL)	3 months	To evaluate self-reported functional use of the limb
Action Research Arm Test (ARAT)	3 months	To evaluate specific changes in arm function from handling objects differing in size, weight and shape

Trial Locations

Locations (1)

University of California, Irvine; 🇺🇸 Irvine, California, United States