Clinical trial NCT00900692: Dynamic Splinting for Excessive Pronation Following CVA
Official title: Dynamic Splinting for Excessive Pronation Following CVA: A Randomized, Controlled Tial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pronation Contracture
Keywords: Excessive pronation
CVA
Forearm
Excessive pronation following CVA
Lead sponsor: Dynasplint Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2009-05-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: ROM changes with use of treatment
timeFrame: 20 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Rehabilitation Associates of Indiana
state: Indiana
Study officials:
affiliation: Rehabilitation Associates of Indiana
name: Marc E Duerden, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Lai JM, Francisco GE, Willis FB. Dynamic splinting after treatment with botulinum toxin type-A: a randomized controlled pilot study. Adv Ther. 2009 Feb;26(2):241-8. doi: 10.1007/s12325-008-0139-2. Epub 2009 Feb 4.