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Clinical Trials/NCT03084705
NCT03084705
Completed
Not Applicable

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

University of California, Irvine1 site in 1 country17 target enrollmentMarch 7, 2018
ConditionsCerebral Stroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Stroke
Sponsor
University of California, Irvine
Enrollment
17
Locations
1
Primary Endpoint
Box and Blocks Test (BBT)
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 7, 2018
End Date
January 13, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David Reinkensmeyer

Professor

University of California, Irvine

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

Outcomes

Primary Outcomes

Box and Blocks Test (BBT)

Time Frame: 3 months

To measure unilateral gross manual dexterity

Secondary Outcomes

  • Fugl-Meyer Motor Assessment (FM)(3 months)
  • Amount of upper extremity activity(3 months)
  • Motor Activity Log (MAL)(3 months)
  • Action Research Arm Test (ARAT)(3 months)

Study Sites (1)

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