Dynamic Splinting for Plantarflexion in Spastic Hemiplegia

Study Overview
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Brief Summary
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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.

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

Conditions
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Spastic Hemiplegia

Intervention / Treatment
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* Device: Ankle Dorsiflexion Dynasplint
* Other: Standard of care


Participation Criteria
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Eligibility Criteria
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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: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>All patients will be treated with the current standard of care including onabotulinum toxin | Other: Standard of care<br>* 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<br>|
| Experimental: Dynasplint<br>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<br>* 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<br>* Other names: ADFD, AFD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in gait pattern |  | 12 weeks |