SupPro Botox: Dynamic Splinting for Excessive Pronation Following CVA
Sponsor
Dynasplint Systems, Inc. (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT00900692
Collaborator
(none)
0
1
2
89
0
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
0 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Dynamic Splinting for Excessive Pronation Following CVA: A Randomized, Controlled Tial
Study Start Date
:
May 1, 2009
Anticipated Primary Completion Date
:
Sep 1, 2016
Anticipated Study Completion Date
:
Oct 1, 2016
Arms and Interventions
| 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. |
Outcome Measures
Primary Outcome Measures
- ROM changes with use of treatment [20 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
- Andreasen DS, Aviles AA, Allen SK, Guthrie KB, Jennings BR, Sprigle SH. Exoskeleton for forearm pronation and supination rehabilitation. Conf Proc IEEE Eng Med Biol Soc. 2004;2004:2714-7.
- Bloemen-Vrencken JH, de Witte LP, Post MW. Follow-up care for persons with spinal cord injury living in the community: a systematic review of interventions and their evaluation. Spinal Cord. 2005 Aug;43(8):462-75. Review.
- Bryden AM, Kilgore KL, Lind BB, Yu DT. Triceps denervation as a predictor of elbow flexion contractures in C5 and C6 tetraplegia. Arch Phys Med Rehabil. 2004 Nov;85(11):1880-5.
- Cooper. Et al. Proceedings of the Stroke Disparities Advisory Panel Meeting, Nov 08, 2002, Bethesda MD, National Institute of Neurological Disorders and Stroke
- Harvey L, de Jong I, Goehl G, Mardwedel S. Twelve weeks of nightly stretch does not reduce thumb web-space contractures in people with a neurological condition: a randomised controlled trial. Aust J Physiother. 2006;52(4):251-8.
- 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. Erratum in: Aust J Physiother. 2008;54(1):38.
- 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.
- Lannin NA, Herbert RD. Is hand splinting effective for adults following stroke? A systematic review and methodologic critique of published research. Clin Rehabil. 2003 Dec;17(8):807-16. Review.
- Mahmood NS, Kadavigere R, Avinash KR, Rao VR. Magnetic resonance imaging in acute cervical spinal cord injury: a correlative study on spinal cord changes and 1 month motor recovery. Spinal Cord. 2008 Dec;46(12):791-7. doi: 10.1038/sc.2008.55. Epub 2008 Jun 10. Erratum in: Spinal Cord. 2009 Jun;47(6):504. Ramesh, A K [corrected to Avinash, K R].
- 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. Review.
- Naik AK, Pathirathna S, Jevtovic-Todorovic V. GABAA receptor modulation in dorsal root ganglia in vivo affects chronic pain after nerve injury. Neuroscience. 2008 Jul 17;154(4):1539-53. doi: 10.1016/j.neuroscience.2008.04.061. Epub 2008 May 3.
- 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.
- Patrick JH, Farmer SE, Bromwich W. Muscle stretching for treatment and prevention of contracture in people with spinal cord injury. Spinal Cord. 2002 Aug;40(8):421-2; author reply 423.
- Tsao CC, Mirbagheri MM. Upper limb impairments associated with spasticity in neurological disorders. J Neuroeng Rehabil. 2007 Nov 29;4:45.
- 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.
Responsible Party:
Dynasplint Systems, Inc.
ClinicalTrials.gov Identifier:
NCT00900692
Other Study ID Numbers:
- 2009.001
First Posted:
May 13, 2009
Last Update Posted:
Jul 11, 2013
Last Verified:
Jul 1, 2013
Keywords provided by Dynasplint Systems, Inc.
Additional relevant MeSH terms: