Spastic Hemiplegia
Conditions
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.
Interventions
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
OTHERStandard 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
Sponsors
Dynasplint Systems, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in gait pattern | 12 weeks |
Countries
United States
Outcome results
None listed