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Dynamic Splinting for Excessive Pronation Following CVA (SupPro Botox)

Primary Purpose

Pronation Contracture

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dynasplint
Sponsored by
Dynasplint Systems, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pronation Contracture focused on measuring Excessive pronation, CVA, Forearm, Excessive pronation following CVA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rehabilitation Associates of Indiana

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Dynasplint Group

Standard of care

Arm Description

Along with the standard of care Botox and manual therapy, patients will use the Supination Dynasplint every day

Patients in the standard of care group will have the standard Botox treatments and manual therapy with no additional interventions.

Outcomes

Primary Outcome Measures

ROM changes with use of treatment

Secondary Outcome Measures

Full Information

First Posted
May 12, 2009
Last Updated
July 10, 2013
Sponsor
Dynasplint Systems, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00900692
Brief Title
Dynamic Splinting for Excessive Pronation Following CVA
Acronym
SupPro Botox
Official Title
Dynamic Splinting for Excessive Pronation Following CVA: A Randomized, Controlled Tial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Withdrawn
Study Start Date
May 2009 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dynasplint Systems, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pronation Contracture
Keywords
Excessive pronation, CVA, Forearm, Excessive pronation following CVA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dynasplint Group
Arm Type
Experimental
Arm Description
Along with the standard of care Botox and manual therapy, patients will use the Supination Dynasplint every day
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Patients in the standard of care group will have the standard Botox treatments and manual therapy with no additional interventions.
Intervention Type
Device
Intervention Name(s)
Dynasplint
Intervention Description
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
Primary Outcome Measure Information:
Title
ROM changes with use of treatment
Time Frame
20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc E Duerden, MD
Organizational Affiliation
Rehabilitation Associates of Indiana
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehabilitation Associates of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17270837
Citation
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PubMed Identifier
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Winchester P, McColl R, Querry R, Foreman N, Mosby J, Tansey K, Williamson J. Changes in supraspinal activation patterns following robotic locomotor therapy in motor-incomplete spinal cord injury. Neurorehabil Neural Repair. 2005 Dec;19(4):313-24. doi: 10.1177/1545968305281515.
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Citation
Cooper. Et al. Proceedings of the Stroke Disparities Advisory Panel Meeting, Nov 08, 2002, Bethesda MD, National Institute of Neurological Disorders and Stroke
Results Reference
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PubMed Identifier
15201473
Citation
McKinley W, Tewksbury MA, Sitter P, Reed J, Floyd S. Assistive technology and computer adaptations for individuals with spinal cord injury. NeuroRehabilitation. 2004;19(2):141-6.
Results Reference
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PubMed Identifier
18047458
Citation
Horsley SA, Herbert RD, Ada L. Four weeks of daily stretch has little or no effect on wrist contracture after stroke: a randomised controlled trial. Aust J Physiother. 2007;53(4):239-45. doi: 10.1016/s0004-9514(07)70004-1. Erratum In: Aust J Physiother. 2008;54(1):38.
Results Reference
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PubMed Identifier
9242860
Citation
Nuismer BA, Ekes AM, Holm MB. The use of low-load prolonged stretch devices in rehabilitation programs in the Pacific northwest. Am J Occup Ther. 1997 Jul-Aug;51(7):538-43. doi: 10.5014/ajot.51.7.538.
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PubMed Identifier
15838530
Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Citation
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PubMed Identifier
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Citation
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Citation
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PubMed Identifier
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Citation
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Results Reference
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Dynamic Splinting for Excessive Pronation Following CVA

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