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Dynamic Splinting for Excessive Pronation Following CVA (SupPro Botox)

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ClinicalTrials.gov Identifier: NCT00900692
Recruitment Status : Withdrawn
First Posted : May 13, 2009
Last Update Posted : July 11, 2013
Sponsor:
Information provided by (Responsible Party):
Dynasplint Systems, Inc.

May 12, 2009
May 13, 2009
July 11, 2013
May 2009
September 2016   (Final data collection date for primary outcome measure)
ROM changes with use of treatment [ Time Frame: 20 weeks ]
Same as current
Complete list of historical versions of study NCT00900692 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Dynamic Splinting for Excessive Pronation Following CVA
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pronation Contracture
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
  • Experimental: Dynasplint Group
    Along with the standard of care Botox and manual therapy, patients will use the Supination Dynasplint every day
    Intervention: Device: Dynasplint
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
50
October 2016
September 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00900692
2009.001
Yes
Not Provided
Not Provided
Dynasplint Systems, Inc.
Dynasplint Systems, Inc.
Not Provided
Principal Investigator: Marc E Duerden, MD Rehabilitation Associates of Indiana
Dynasplint Systems, Inc.
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP