Dynamic Splinting for Plantarflexion in Spastic Hemiplegia
NCT ID: NCT01329705
Last Updated: 2013-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2011-05-31
2015-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
All patients will be treated with the current standard of care including onabotulinum toxin
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
Dynasplint
Patients in the experimental Dynasplint group will be treated with the current standard of care, including onabotulinum toxin, and use the Ankle Dorsiflexion Dynasplint
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
Interventions
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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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
80 Years
ALL
No
Sponsors
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Dynasplint Systems, Inc.
INDUSTRY
Responsible Party
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Locations
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Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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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.
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.
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.
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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.
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.
Lam T, Luttmann K, Houldin A, Chan C. Treadmill-based locomotor training with leg weights to enhance functional ambulation in people with chronic stroke: a pilot study. J Neurol Phys Ther. 2009 Sep;33(3):129-35. doi: 10.1097/NPT.0b013e3181b57de5.
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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.
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.
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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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Hesse S, Lucke D, Malezic M, Bertelt C, Friedrich H, Gregoric M, Mauritz KH. Botulinum toxin treatment for lower limb extensor spasticity in chronic hemiparetic patients. J Neurol Neurosurg Psychiatry. 1994 Nov;57(11):1321-4. doi: 10.1136/jnnp.57.11.1321.
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Other Identifiers
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Dyna-2011
Identifier Type: -
Identifier Source: org_study_id