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Spastic HemiplegiaNCT01329705

Dynamic Splinting for Plantarflexion in Spastic Hemiplegia

A study testing Ankle Dorsiflexion Dynasplint in people with Spastic Hemiplegia, run by Dynasplint Systems, Inc. at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Spastic Hemiplegia
What is being tested?
Ankle Dorsiflexion Dynasplint
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
May 2011to Aug 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

Other trials in United States

About this study

Official title: 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.

Being tested
Ankle Dorsiflexion Dynasplint, Standard of care
Medical subject headings
Hemiplegia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ankle Dorsiflexion DynasplintDevice

    Also called ADFD, AFD

    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

  • Standard of careOther

    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
Study groups in NCT01329705
Study groupRoleWhat they receive
ControlActive comparatorAll patients will be treated with the current standard of care including onabotulinum toxin
Receives: Other: Standard of care
DynasplintExperimentalPatients in the experimental Dynasplint group will be treated with the current standard of care, including onabotulinum toxin, and use the Ankle Dorsiflexion Dynasplint
Receives: Device: Ankle Dorsiflexion Dynasplint

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in gait pattern

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionMay 2015 (estimated)
  4. Study completionAug 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01329705
Sponsor's protocol ID
Dyna-2011
Status last verified
Aug 2013
First submitted
4 Apr 2011
Last updated
12 Aug 2013
Results posted
No
Data monitoring committee
No

Publications

  • Abe H, Michimata A, Sugawara K, Sugaya N, Izumi S. Improving gait stability in stroke hemiplegic patients with a plastic ankle-foot orthosis. Tohoku J Exp Med. 2009 Jul;218(3):193-9. doi: 10.1620/tjem.218.193.

    PubMed 19561389

  • Cormack J, Powers CM. Is there evidence that botulinum toxin injections are more effective than phenol injections in relieving poststroke reflex activity during plantar flexion, thereby increasing ankle range of motion and improving gait function? Phys Ther. 2004 Jan;84(1):76-84. No abstract available.

    PubMed 14992678

  • Cruz TH, Dhaher YY. Impact of ankle-foot-orthosis on frontal plane behaviors post-stroke. Gait Posture. 2009 Oct;30(3):312-6. doi: 10.1016/j.gaitpost.2009.05.018. Epub 2009 Jun 30.

    PubMed 19570678

  • Franceschini M, Carda S, Agosti M, Antenucci R, Malgrati D, Cisari C; Gruppo Italiano Studio Allevio Carico Ictus. Walking after stroke: what does treadmill training with body weight support add to overground gait training in patients early after stroke?: a single-blind, randomized, controlled trial. Stroke. 2009 Sep;40(9):3079-85. doi: 10.1161/STROKEAHA.109.555540. Epub 2009 Jun 25.

    PubMed 19556526

  • Freivogel S, Schmalohr D, Mehrholz J. Improved walking ability and reduced therapeutic stress with an electromechanical gait device. J Rehabil Med. 2009 Sep;41(9):734-9. doi: 10.2340/16501977-0422.

    PubMed 19774307

  • Johnson CA, Burridge JH, Strike PW, Wood DE, Swain ID. The effect of combined use of botulinum toxin type A and functional electric stimulation in the treatment of spastic drop foot after stroke: a preliminary investigation. Arch Phys Med Rehabil. 2004 Jun;85(6):902-9. doi: 10.1016/j.apmr.2003.08.081.

    PubMed 15179643

  • Kesar TM, Perumal R, Reisman DS, Jancosko A, Rudolph KS, Higginson JS, Binder-Macleod SA. Functional electrical stimulation of ankle plantarflexor and dorsiflexor muscles: effects on poststroke gait. Stroke. 2009 Dec;40(12):3821-7. doi: 10.1161/STROKEAHA.109.560375. Epub 2009 Oct 15.

    PubMed 19834018

  • Kim JH, Jang SH, Kim CS, Jung JH, You JH. Use of virtual reality to enhance balance and ambulation in chronic stroke: a double-blind, randomized controlled study. Am J Phys Med Rehabil. 2009 Sep;88(9):693-701. doi: 10.1097/PHM.0b013e3181b33350.

    PubMed 19692788

  • Lam T, Luttmann K, Houldin A, Chan C. Treadmill-based locomotor training with leg weights to enhance functional ambulation in people with chronic stroke: a pilot study. J Neurol Phys Ther. 2009 Sep;33(3):129-35. doi: 10.1097/NPT.0b013e3181b57de5.

    PubMed 19809391

  • Lai JM, Francisco GE, Willis FB. Dynamic splinting after treatment with botulinum toxin type-A: a randomized controlled pilot study. Adv Ther. 2009 Feb;26(2):241-8. doi: 10.1007/s12325-008-0139-2. Epub 2009 Feb 4.

    PubMed 19194671

  • John MM, Willis FB, Portillo A. Dynamic splinting for runner's toe: a case report with gait analysis. J Am Podiatr Med Assoc. 2009 Jul-Aug;99(4):367-70. doi: 10.7547/0980367.

    PubMed 19605933

  • Masiero S, Briani C, Marchese-Ragona R, Giacometti P, Costantini M, Zaninotto G. Successful treatment of long-standing post-stroke dysphagia with botulinum toxin and rehabilitation. J Rehabil Med. 2006 May;38(3):201-3. doi: 10.1080/16501970500515840.

    PubMed 16702088

  • McGuire JR. Effective use of chemodenervation and chemical neurolysis in the management of poststroke spasticity. Top Stroke Rehabil. 2001 Spring;8(1):47-55. doi: 10.1310/CYP4-BPXC-CG8M-XCA3.

    PubMed 14523751

  • Michael K, Goldberg AP, Treuth MS, Beans J, Normandt P, Macko RF. Progressive adaptive physical activity in stroke improves balance, gait, and fitness: preliminary results. Top Stroke Rehabil. 2009 Mar-Apr;16(2):133-9. doi: 10.1310/tsr1602-133.

    PubMed 19581199

  • Pleis JR, Lucas JW, Ward BW. Summary health statistics for U.S. adults: National Health Interview Survey, 2008. Vital Health Stat 10. 2009 Dec;(242):1-157.

    PubMed 20821903

Questions about this trial

What is this clinical trial studying?

A study testing Ankle Dorsiflexion Dynasplint in people with Spastic Hemiplegia, run by Dynasplint Systems, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in gait pattern (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01329705, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2013; AzTrials last refreshed its copy on 31 Oct 2026.

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