Dynamic Splinting for Plantarflexion in Spastic Hemiplegia

NCT01329705 | Withdrawn

• 1 other identifier: Dyna-2011
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spastic Hemiplegia

Outcome Measures

Primary Outcomes (1)

• Change in gait pattern

  12 weeks

Study Arms (2)

Control

ACTIVE COMPARATOR

All patients will be treated with the current standard of care including onabotulinum toxin

Other: Standard of care

Dynasplint

EXPERIMENTAL

Patients in the experimental Dynasplint group will be treated with the current standard of care, including onabotulinum toxin, and use the Ankle Dorsiflexion Dynasplint

Device: Ankle Dorsiflexion Dynasplint

Interventions

Ankle Dorsiflexion Dynasplint DEVICE

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

Also known as: ADFD, AFD

Dynasplint

Standard of care OTHER

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

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Diagnosis of a stroke or traumatic brain injury more than 6 months prior to enrollment in this study
• Reduced AROM and PROM in ankle dorsiflexion
• Ability to ambulate safely 20 feet without an ankle-foot orthosis (AFO)
• Inability to ambulate with initial heel-contact
• No prior BTX treatment within 6 months
• R1 of -10° or greater (using the Tardeiu method of assessment)
• Mean Ashworth Scale Test ≥3 for plantarflexors

You may not qualify if:

• Bell's Palsy
• Viral Encephalitis
• Muscular Dystrophy
• Multiple Sclerosis
• Prior heel-cord lengthening or tendon-transfer procedure in the foot/ankle
• Subjects with a fixed contracture of the ankle
• 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
• Bleeding disorders
• Diagnosis of a disease that may interfere with neuromuscular function (ie. Myasthenia Gravis, Lambert-Eaton Myasthenic Syndrome, amyotrophic lateral sclerosis)
• Subjects currently using aminoglycoside antibiotics, curare-like agents, or other agents that may interfere with neuromuscular function
• Subjects with profound weakness or atrophy of the muscles in the target areas of injection
• Active systemic infection or infection at the injection site
• Allergy or sensitivity to botulinum toxin A

Sponsors & Collaborators

• Dynasplint Systems, Inc.: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related 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. doi: 10.1620/tjem.218.193.

  PMID: 19561389 BACKGROUND

• 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. No abstract available.

  PMID: 14992678 BACKGROUND

• 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.

  PMID: 19570678 BACKGROUND

• Franceschini M, Carda S, Agosti M, Antenucci R, Malgrati D, Cisari C; Gruppo Italiano Studio Allevio Carico Ictus. Walking after stroke: what does treadmill training with body weight support add to overground gait training in patients early after stroke?: a single-blind, randomized, controlled trial. Stroke. 2009 Sep;40(9):3079-85. doi: 10.1161/STROKEAHA.109.555540. Epub 2009 Jun 25.

  PMID: 19556526 BACKGROUND

• 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.

  PMID: 19774307 BACKGROUND

• 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. doi: 10.1016/j.apmr.2003.08.081.

  PMID: 15179643 BACKGROUND

• 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.

  PMID: 19834018 BACKGROUND

• 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.

  PMID: 19692788 BACKGROUND

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• 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.

  PMID: 19194671 BACKGROUND

• 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. doi: 10.7547/0980367.

  PMID: 19605933 BACKGROUND

• 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. doi: 10.1080/16501970500515840.

  PMID: 16702088 BACKGROUND

• McGuire JR. Effective use of chemodenervation and chemical neurolysis in the management of poststroke spasticity. Top Stroke Rehabil. 2001 Spring;8(1):47-55. doi: 10.1310/CYP4-BPXC-CG8M-XCA3.

  PMID: 14523751 BACKGROUND

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  PMID: 19581199 BACKGROUND

• Pleis JR, Lucas JW, Ward BW. Summary health statistics for U.S. adults: National Health Interview Survey, 2008. Vital Health Stat 10. 2009 Dec;(242):1-157.

  PMID: 20821903 BACKGROUND

• 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;2009(3):CD006075. doi: 10.1002/14651858.CD006075.pub2.

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• 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.

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• 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. doi: 10.1097/BLO.0b013e31803212bf.

  PMID: 17224840 BACKGROUND

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

  BACKGROUND

• 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.

  BACKGROUND

• 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. No abstract available.

  PMID: 20813995 BACKGROUND

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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.

  BACKGROUND

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  PMID: 11992980 BACKGROUND

MeSH Terms

Conditions

Hemiplegia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2011
• First Posted: April 6, 2011
• Study Start: May 1, 2011
• Primary Completion: May 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 12, 2013

Record last verified: 2013-08

Locations

US (1)