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Dynamic Splinting for Plantarflexion in Spastic Hemiplegia

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Dynasplint Systems, Inc.
ClinicalTrials.gov Identifier:
NCT01329705
First received: April 4, 2011
Last updated: August 8, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Spastic Hemiplegia
Device: Ankle Dorsiflexion Dynasplint
Other: Standard of care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dynamic Splinting for Excessive Plantarflexion in Patients With Spastic Hemiplegia: A Randomized, Controlled Study of Gait Analysis

Resource links provided by NLM:


Further study details as provided by Dynasplint Systems, Inc.:

Primary Outcome Measures:
  • Change in gait pattern [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: May 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: ADFD, AFD

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01329705

Locations
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Dynasplint Systems, Inc.
  More Information

Publications:
Willis, F. B. Post-TBI Gait Rehabilitation. Applied Neurol. 2007 Jul;3(7):25-26.

Responsible Party: Dynasplint Systems, Inc.
ClinicalTrials.gov Identifier: NCT01329705     History of Changes
Other Study ID Numbers: Dyna-2011
Study First Received: April 4, 2011
Last Updated: August 8, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hemiplegia
Nervous System Diseases
Neurologic Manifestations
Paralysis
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014