NCT01329705

Dynamic Splinting for Plantarflexion in Spastic Hemiplegia

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Dynasplint Systems, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spastic Hemiplegia

Interventions

Type	Name	Description
DEVICE	Ankle Dorsiflexion Dynasplint	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
OTHER	Standard 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

Timeline

• Start date: 2011-05-01
• Primary completion: 2015-05-01
• Completion: 2015-08-01
• First posted: 2011-04-06
• Last updated: 2013-08-12

Locations

1 site across 1 country: United States