Dynamic Splinting for Plantarflexion in Spastic Hemiplegia

Spastic Hemiplegia Clinical Trial

Official title:

Dynamic Splinting for Excessive Plantarflexion in Patients With Spastic Hemiplegia: A Randomized, Controlled Study of Gait Analysis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01329705
• Other study ID #: Dyna-2011
• Status: Withdrawn
• Phase: N/A
• First received: April 4, 2011
• Last updated: August 8, 2013
• Start date: May 2011
• Est. completion date: August 2015

Study information

• Verified date: August 2013
• Source: Dynasplint Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine the effectiveness of onabotulinum toxin A (BTX) injections (tone management) and dynamic splinting (contracture reduction) for improving gait patterns in patients with spastic hypertnoia due to stroke or traumatic brain injury and resultant excessive plantarflexion.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients enrolled will be male or female, be at least 18 years of age, and have been diagnosed with spastic hemiplegia and excessive plantarflexion, which includes the following:

1. Diagnosis of a stroke or traumatic brain injury more than 6 months prior to enrollment in this study

2. Reduced AROM and PROM in ankle dorsiflexion

3. Ability to ambulate safely 20 feet without an ankle-foot orthosis (AFO)

4. Inability to ambulate with initial heel-contact

5. No prior BTX treatment within 6 months

6. R1 of -10° or greater (using the Tardeiu method of assessment)

7. Mean Ashworth Scale Test =3 for plantarflexors

Exclusion Criteria:

1. Bell's Palsy

2. Viral Encephalitis

3. Muscular Dystrophy

4. Multiple Sclerosis

5. Prior heel-cord lengthening or tendon-transfer procedure in the foot/ankle

6. Subjects with a fixed contracture of the ankle

7. Female subjects who are pregnant (positive urine pregnancy test), who have an infant they are breastfeeding, or are of childbearing potential and do not practice a reliable method of birth control

8. Bleeding disorders

9. Diagnosis of a disease that may interfere with neuromuscular function (ie. Myasthenia Gravis, Lambert-Eaton Myasthenic Syndrome, amyotrophic lateral sclerosis)

10. Subjects currently using aminoglycoside antibiotics, curare-like agents, or other agents that may interfere with neuromuscular function

11. Subjects with profound weakness or atrophy of the muscles in the target areas of injection

12. Active systemic infection or infection at the injection site

13. Allergy or sensitivity to botulinum toxin A

Study Design

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

Related Conditions & MeSH terms

• Hemiplegia
• Muscle Spasticity
• Spastic Hemiplegia

Intervention

Device:
• Ankle Dorsiflexion 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

Other:
• Standard of care
Patients will begin a 12 week course of physical therapy with once-weekly therapy appointment, focusing on: range of motion stretching of the Achilles tendon, hamstrings, hip flexors and any other tight musculature strengthening of tibialis anterior to allow dorsiflexion in swing phase of gait as well as strengthening of other weak musculature gait training to improve heel strike and toe off, stride length, and gait progression sensory, proprioceptive training in foot position and degree of plantarflexion or dorsiflexion no electric stimulation (e-stim) will be utilized

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Dynasplint Systems, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (26)

Abe H, Michimata A, Sugawara K, Sugaya N, Izumi S. Improving gait stability in stroke hemiplegic patients with a plastic ankle-foot orthosis. Tohoku J Exp Med. 2009 Jul;218(3):193-9. — View Citation

Cormack J, Powers CM. Is there evidence that botulinum toxin injections are more effective than phenol injections in relieving poststroke reflex activity during plantar flexion, thereby increasing ankle range of motion and improving gait function? Phys Ther. 2004 Jan;84(1):76-84. — View Citation

Cruz TH, Dhaher YY. Impact of ankle-foot-orthosis on frontal plane behaviors post-stroke. Gait Posture. 2009 Oct;30(3):312-6. doi: 10.1016/j.gaitpost.2009.05.018. Epub 2009 Jun 30. — View Citation

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Freivogel S, Schmalohr D, Mehrholz J. Improved walking ability and reduced therapeutic stress with an electromechanical gait device. J Rehabil Med. 2009 Sep;41(9):734-9. doi: 10.2340/16501977-0422. — View Citation

Harvey L, Herbert R, Crosbie J. Does stretching induce lasting increases in joint ROM? A systematic review. Physiother Res Int. 2002;7(1):1-13. Review. — View Citation

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John MM, Willis FB, Portillo A. Dynamic splinting for runner's toe: a case report with gait analysis. J Am Podiatr Med Assoc. 2009 Jul-Aug;99(4):367-70. — View Citation

Johnson CA, Burridge JH, Strike PW, Wood DE, Swain ID. The effect of combined use of botulinum toxin type A and functional electric stimulation in the treatment of spastic drop foot after stroke: a preliminary investigation. Arch Phys Med Rehabil. 2004 Jun;85(6):902-9. — View Citation

Kesar TM, Perumal R, Reisman DS, Jancosko A, Rudolph KS, Higginson JS, Binder-Macleod SA. Functional electrical stimulation of ankle plantarflexor and dorsiflexor muscles: effects on poststroke gait. Stroke. 2009 Dec;40(12):3821-7. doi: 10.1161/STROKEAHA.109.560375. Epub 2009 Oct 15. — View Citation

Kim JH, Jang SH, Kim CS, Jung JH, You JH. Use of virtual reality to enhance balance and ambulation in chronic stroke: a double-blind, randomized controlled study. Am J Phys Med Rehabil. 2009 Sep;88(9):693-701. doi: 10.1097/PHM.0b013e3181b33350. — View 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. — View Citation

Lai JM, Jones M, and Willis FB. Effect of Dynamic Splinting on Excessive Plantarflexion Tone/Contracture: A Controlled, Crossover Study. Proceedings of the 16th European Congress of Physical and Rehabilitation Medicine. Minerva Medica pubs, Italy, August 2008, pg 106-109.

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Masiero S, Briani C, Marchese-Ragona R, Giacometti P, Costantini M, Zaninotto G. Successful treatment of long-standing post-stroke dysphagia with botulinum toxin and rehabilitation. J Rehabil Med. 2006 May;38(3):201-3. — View Citation

McGuire JR. Effective use of chemodenervation and chemical neurolysis in the management of poststroke spasticity. Top Stroke Rehabil. 2001 Spring;8(1):47-55. — View Citation

Michael K, Goldberg AP, Treuth MS, Beans J, Normandt P, Macko RF. Progressive adaptive physical activity in stroke improves balance, gait, and fitness: preliminary results. Top Stroke Rehabil. 2009 Mar-Apr;16(2):133-9. doi: 10.1310/tsr1602-133. — View Citation

Miller EL, Murray L, Richards L, Zorowitz RD, Bakas T, Clark P, Billinger SA; American Heart Association Council on Cardiovascular Nursing and the Stroke Council. Comprehensive overview of nursing and interdisciplinary rehabilitation care of the stroke patient: a scientific statement from the American Heart Association. Stroke. 2010 Oct;41(10):2402-48. doi: 10.1161/STR.0b013e3181e7512b. Epub 2010 Sep 2. — View Citation

Pittock SJ, Moore AP, Hardiman O, Ehler E, Kovac M, Bojakowski J, Al Khawaja I, Brozman M, Kanovský P, Skorometz A, Slawek J, Reichel G, Stenner A, Timerbaeva S, Stelmasiak Z, Zifko UA, Bhakta B, Coxon E. A double-blind randomised placebo-controlled evaluation of three doses of botulinum toxin type A (Dysport) in the treatment of spastic equinovarus deformity after stroke. Cerebrovasc Dis. 2003;15(4):289-300. — View Citation

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Sheean G. Neurophysiology of spasticity. In: Barnes MP, Johnson GR. Upper motor neuron syndrome and spasticity. Cambridge University Press, 2008: 9-63.

States RA, Pappas E, Salem Y. Overground physical therapy gait training for chronic stroke patients with mobility deficits. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD006075. doi: 10.1002/14651858.CD006075.pub2. Review. — View Citation

Stock R, Mork PJ. The effect of an intensive exercise programme on leg function in chronic stroke patients: a pilot study with one-year follow-up. Clin Rehabil. 2009 Sep;23(9):790-9. doi: 10.1177/0269215509335291. Epub 2009 Jun 26. — View Citation

Usuba M, Akai M, Shirasaki Y, Miyakawa S. Experimental joint contracture correction with low torque--long duration repeated stretching. Clin Orthop Relat Res. 2007 Mar;456:70-8. — View Citation

Willis, F. B. Post-TBI Gait Rehabilitation. Applied Neurol. 2007 Jul;3(7):25-26.

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in gait pattern		12 weeks	No