Quantification of UE Use and Effects of Feedback in the Home Setting (OPTASpr2016)

September 25, 2017 updated by: Maureen Whitford, Cleveland State University

The investigators are proposing a pilot study, the purpose of which is to use accelerometers to quantify UE use (1 and two hand use) in people post-stroke from which the investigators will develop use-based feedback to improve recovery in the home setting. The objectives of this pilot study are to:

i.) determine the feasibility of using accelerometers to quantify amount of UE use in the home setting in individuals chronic post-stroke,

ii.) quantify and compare the unilateral activity of the weaker (paretic) versus stronger (non-paretic) UEs, and

iii.) assess the effect of a 7 sessions of in-home accelerometer used-based feedback on unilateral and bilateral UE use.

iv.) assess kinematic, kinetic, and EMG data during UE movements unilaterally and bilaterally in subjects post-chronic stroke pre and post feedback.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects post-stroke
  • chronic post ischemic or hemorrhagic cortical or subcortical stroke
  • 25 - 100 years old
  • upper extremity impairment
  • Subjects will need to be able to flex their paretic shoulder and their elbow > 40° without assist
  • able to follow 2-step commands
  • community dwelling with or without assistance
  • intact superficial light touch sensation in both upper extremities
  • must also have some movement in both arms

Exclusion Criteria:

  • can't currently have another neuromuscular disorders such as spinal cord injury, traumatic brain injury, Parkinson disease or multiple sclerosis
  • no upper extremity injury within the last 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Feedback Intervention
Behavioral: Accelerometer based feedback about paretic arm use

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Accelerometer based paretic arm amount of use
Time Frame: 3 week period
3 week period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cleveland State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

December 14, 2016

First Submitted That Met QC Criteria

December 15, 2016

First Posted (Estimate)

December 16, 2016

Study Record Updates

Last Update Posted (Actual)

September 26, 2017

Last Update Submitted That Met QC Criteria

September 25, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • IRB-FY2016-84

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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