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Dynamic Splinting for Plantarflexion in Spastic Hemiplegia

NCT01329705 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2013-08-12

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Dynasplint Systems, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2015-05-31
Completion
2015-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01329705 on ClinicalTrials.gov