NCT01329705WithdrawnNot Applicable
Dynamic Splinting for Excessive Plantarflexion in Patients With Spastic Hemiplegia: A Randomized, Controlled Study of Gait Analysis
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Dynasplint Systems, Inc.
- Locations
- 2
- Primary Endpoint
- Change in gait pattern
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- 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:
- •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
Outcomes
Primary Outcomes
Change in gait pattern
Time Frame: 12 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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