Dynamic Splinting for Plantarflexion in Spastic Hemiplegia

Withdrawn before enrolling · Not applicable

Conditions studied: Spastic Hemiplegia

In brief

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.

Key facts

Study ID

NCT01329705

Run by

Dynasplint Systems, Inc.

People needed

0

Starts

2011-05-01

Expected to finish

2015-08-01

Last updated by the study team

2013-08-12

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.