CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 18 enrolled
Drug / intervention
occupational therapy task-oriented approach +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01987414
NCT01987414N/ACompleted

Efficacy of a Forearm Rotation Orthosis for Persons With a Hemiparetic Arm

University of Minnesota·interventional·Posted Nov 19, 2013·Updated Sep 6, 2019

In Brief

A clinical study evaluating occupational therapy task-oriented approach, Forearm rotation orthosis, and 1 other intervention for Stroke. Completed, enrolled 18 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 19, 2013
Enrollment StartAug 1, 2015
Primary CompletionJun 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 12.6 years ago

Interventions

occupational therapy task-oriented approachbehavioral

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.

Forearm rotation orthosisdevice

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.

No treatmentother

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