Dynamic Splinting for Excessive Pronation Following CVA NCT00900692

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number	NCT00900692
Other study ID #	2009.001
Secondary ID
Status	Withdrawn
Phase	N/A
First received	May 12, 2009
Last updated	July 10, 2013
Start date	May 2009
Est. completion date	October 2016

Study information
Verified date	July 2013
Source	Dynasplint Systems, Inc.
Contact	n/a
Is FDA regulated	No
Health authority	United States: Institutional Review Board
Study type	Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status	Withdrawn
Enrollment	0
Est. completion date	October 2016
Est. primary completion date	September 2016
Accepts healthy volunteers	No
Gender	Both
Age group	18 Years and older
Eligibility	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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country	Name	City	State
United States	Rehabilitation Associates of Indiana	Indianapolis	Indiana

Sponsors *(1)*
Lead Sponsor	Collaborator
Dynasplint Systems, Inc.

Country where clinical trial is conducted

United States,

References & Publications (15)

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;4:2714-7. — View Citation

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. — View Citation

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. — View Citation

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. — View 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. Erratum in: Aust J Physiother. 2008;54(1):38. — View Citation

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)

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. — View Citation

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]. — View 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. Review. — View Citation

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. — View 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. — View Citation

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. — View Citation

Tsao CC, Mirbagheri MM. Upper limb impairments associated with spasticity in neurological disorders. J Neuroeng Rehabil. 2007 Nov 29;4:45. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	ROM changes with use of treatment		20 weeks	No

Dynamic Splinting for Excessive Pronation Following CVA

Clinical Trial Details — Status: Withdrawn

Administrative data

Study information

Clinical Trial Summary

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Intervention

Locations

Sponsors (1)

Country where clinical trial is conducted

References & Publications (15)

Outcome