Clinical trial NCT01329705: Dynamic Splinting for Plantarflexion in Spastic Hemiplegia
Official title: Dynamic Splinting for Excessive Plantarflexion in Patients With Spastic Hemiplegia: A Randomized, Controlled Study of Gait Analysis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Spastic Hemiplegia
Lead sponsor: Dynasplint Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2011-04-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in gait pattern
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References:
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