Dynamic Splinting for Plantarflexion in Spastic Hemiplegia

August 8, 2013 updated by: Dynasplint Systems, Inc.

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

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
All patients will be treated with the current standard of care including onabotulinum toxin
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
Experimental: Dynasplint
Patients in the experimental Dynasplint group will be treated with the current standard of care, including onabotulinum toxin, and use the Ankle Dorsiflexion Dynasplint
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 Names:
  • ADFD, AFD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in gait pattern
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dynasplint Systems, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Anticipated)

May 1, 2015

Study Completion (Anticipated)

August 1, 2015

Study Registration Dates

First Submitted

April 4, 2011

First Submitted That Met QC Criteria

April 5, 2011

First Posted (Estimate)

April 6, 2011

Study Record Updates

Last Update Posted (Estimate)

August 12, 2013

Last Update Submitted That Met QC Criteria

August 8, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dyna-2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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