Wearable Device for Motivating Hand Use After Stroke

NCT03084705 | Completed

• 1 other identifier: NIH HS# 2017-4119
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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

Conditions

Cerebral Stroke

Outcome Measures

Primary Outcomes (1)

• Box and Blocks Test (BBT)

  To measure unilateral gross manual dexterity

  3 months

Secondary Outcomes (4)

• Action Research Arm Test (ARAT)

  3 months

• Fugl-Meyer Motor Assessment (FM)

  3 months

• Motor Activity Log (MAL)

  3 months

• Amount of upper extremity activity

  3 months

Study Arms (2)

Manumeter with interactive feedback

EXPERIMENTAL

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

Device: Manumeter

Manumeter without interactive feedback

EXPERIMENTAL

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.

Device: Manumeter

Interventions

Manumeter 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 with interactive feedback; Manumeter without interactive feedback

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine

Irvine, California, 92697, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• David Reinkensmeyer, PhD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: March 21, 2017
• Study Start: March 7, 2018
• Primary Completion: August 19, 2019
• Study Completion: January 13, 2020
• Last Updated: March 29, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)