Dynamic Splinting for Plantarflexion in Spastic Hemiplegia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01329705
Recruitment Status : Withdrawn
First Posted : April 6, 2011
Last Update Posted : August 12, 2013
Information provided by (Responsible Party):
Dynasplint Systems, Inc.

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.

Condition or disease Intervention/treatment Phase
Spastic Hemiplegia Device: Ankle Dorsiflexion Dynasplint Other: Standard of care Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dynamic Splinting for Excessive Plantarflexion in Patients With Spastic Hemiplegia: A Randomized, Controlled Study of Gait Analysis
Study Start Date : May 2011
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : August 2015

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U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Control
All patients will be treated with the current standard of care including onabotulinum toxin
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
Experimental: 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
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 Name: ADFD, AFD

Primary Outcome Measures :
  1. Change in gait pattern [ Time Frame: 12 weeks ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01329705

United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Dynasplint Systems, Inc.

Willis, F. B. Post-TBI Gait Rehabilitation. Applied Neurol. 2007 Jul;3(7):25-26.
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.
Sheean G. Neurophysiology of spasticity. In: Barnes MP, Johnson GR. Upper motor neuron syndrome and spasticity. Cambridge University Press, 2008: 9-63.

Responsible Party: Dynasplint Systems, Inc. Identifier: NCT01329705     History of Changes
Other Study ID Numbers: Dyna-2011
First Posted: April 6, 2011    Key Record Dates
Last Update Posted: August 12, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms