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Forearm Rotation Orthosis for Stroke

NCT01987414 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2019-09-06

Study results available
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Summary

The purpose of this study is to examine the efficacy of a forearm rotation orthosis combined with the occupational therapy task-oriented approach on functional performance for persons with a hemiparetic arm.

Hypotheses of this study are:

1. participants who wear the forearm rotation orthosis will demonstrate significantly greater improvement in functional performance and active range of motion of forearm rotators compared to those who do not;
2. all participants who receive the occupational therapy task-oriented approach intervention will demonstrate significant improvement in functional performance; and
3. all participants who receive the occupational therapy task-oriented approach intervention will demonstrate improvement in motor function of the upper extremity.

Conditions

Interventions

BEHAVIORAL

occupational therapy task-oriented approach

It is a standard treatment in occupational therapy for persons post-stroke or other neurological conditions. It is an approach that emphasizes client-centered, goal-directed, and functional training for restoration of life roles.

DEVICE

Forearm rotation orthosis

The forearm rotation orthosis is made of Latex-free material and is a custom-molded orthosis designed to assist forearm rotation without limiting functional elbow flexion and extension.

OTHER

No treatment

Participants will maintain their daily routines during the no treatment period.

Sponsors & Collaborators

Principal Investigators

  • Chih-Huang Yu, MS · Rehabilitation Science Program at the University of Minnesota

  • Virgil Mathiowetz, PhD · Program in Occupational Therapy, University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01987414 on ClinicalTrials.gov