Dynamic Splinting for Excessive Pronation Following CVA (SupPro Botox)

July 10, 2013 updated by: Dynasplint Systems, Inc.

Dynamic Splinting for Excessive Pronation Following CVA: A Randomized, Controlled Tial

The purpose of this study is to examine range of motion and lasting effects of Botox injections along with the use of the Supination Dynasplint.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Rehabilitation Associates of Indiana

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Patients enrolled will have been diagnosed with excessive pronation following a stroke and will display the following symptoms:

  • Pronation Contracture
  • Ability to provide consent and follow directions as related to the protocol

Exclusion Criteria

  • Treatment with Benzodiazepines
  • Treatment with Baclofen (pump or oral)
  • Treatment with Dantrolene sodium
  • Treatment with Tizanidine

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: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dynasplint Group
Along with the standard of care Botox and manual therapy, patients will use the Supination Dynasplint every day
Device: Dynasplint
Dynamic splinting utilizes the protocols of Low-Load Prolonged Stretch (LLPS) with calibrated adjustable tension to increase Total End Range Time (TERT)to reduce contracture. The Dynasplint or "Experimental" group will add this therapy to their standard of care regimen
No Intervention: Standard of care
Patients in the standard of care group will have the standard Botox treatments and manual therapy with no additional interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ROM changes with use of treatment
Time Frame: 20 weeks
20 weeks

Collaborators and Investigators

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

Sponsor

Dynasplint Systems, Inc.

Investigators

  • Principal Investigator: Marc E Duerden, MD, Rehabilitation Associates of Indiana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2009

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

May 12, 2009

First Submitted That Met QC Criteria

May 12, 2009

First Posted (Estimate)

May 13, 2009

Study Record Updates

Last Update Posted (Estimate)

July 11, 2013

Last Update Submitted That Met QC Criteria

July 10, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009.001

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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