Dynamic Splinting for Excessive Pronation Following CVA (SupPro Botox)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Dynasplint Systems, Inc.
ClinicalTrials.gov Identifier:
NCT00900692
First received: May 12, 2009
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Pronation Contracture
Device: Dynasplint

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dynamic Splinting for Excessive Pronation Following CVA: A Randomized, Controlled Tial

Resource links provided by NLM:


Further study details as provided by Dynasplint Systems, Inc.:

Primary Outcome Measures:
  • ROM changes with use of treatment [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: May 2009
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00900692

Locations
United States, Indiana
Rehabilitation Associates of Indiana
Indianapolis, Indiana, United States, 46250
Sponsors and Collaborators
Dynasplint Systems, Inc.
Investigators
Principal Investigator: Marc E Duerden, MD Rehabilitation Associates of Indiana
  More Information

Publications:
Lai JM, Francisco GE, Willis FB. Dynamic Splinting on Range of Motion and Spasticity after Treatment with Botulinum Toxin-A: a Randomized, Controlled Pilot Study. Advances in Therapy. (March 2009, E-Pub February)

Responsible Party: Dynasplint Systems, Inc.
ClinicalTrials.gov Identifier: NCT00900692     History of Changes
Other Study ID Numbers: 2009.001
Study First Received: May 12, 2009
Last Updated: July 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Dynasplint Systems, Inc.:
Excessive pronation
CVA
Forearm
Excessive pronation following CVA

Additional relevant MeSH terms:
Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases

ClinicalTrials.gov processed this record on September 22, 2014