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Hallux Limitus Treated With Dynamic Splinting: A Randomized, Controlled Trial

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ClinicalTrials.gov Identifier: NCT00717691
Recruitment Status : Completed
First Posted : July 17, 2008
Last Update Posted : April 30, 2012
Sponsor:
Information provided by (Responsible Party):
Dynasplint Systems, Inc.

Brief Summary:
The purpose of this study is to regain range of motion of the great toe with dynamic splinting which will help reduce great toe's pain and swelling.

Condition or disease Intervention/treatment Phase
Hallux Limitus Device: Metatarsophalangeal Extension Dynasplint System Other: Standard of Care Not Applicable

Detailed Description:
Determine the efficacy of dynamic splinting in treating patients with hallux limitus, in a randomized, controlled trial.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hallux Limitus Treated With Dynamic Splinting: A Randomized, Controlled Trial
Study Start Date : July 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : December 2008

Arm Intervention/treatment
Experimental: 1
Immediate fitting with dynamic splinting following diagnosis of hallux limitus.
Device: Metatarsophalangeal Extension Dynasplint System
Dynamic Splinting utilizes the protocols of Low-Load, Prolonged-Duration Stretch (LLPS) with calibrated, adjustable tension to increase the Total End Range Time (TERT) to reduce contracture. This unit is worn for 30 minutes, three times per day, (while seated or resting in bed) totaling 1.5 hours per day.
Other: Standard of Care
The current standard of care in treating Hallux Limitus will be given to all patients regardless of randomized categorization, and this includes: analgesic and nonsteroidal anti-inflammatory drugs (NSAIDs), orthotics with medial stiffness, and reduction of great toe movement in motions such as kneeling or squatting with the toes in an extended position.
No Intervention: 2
Control arm; patients only treated with standard of care following diagnosis of hallux limitus.
Other: Standard of Care
The current standard of care in treating Hallux Limitus will be given to all patients regardless of randomized categorization, and this includes: analgesic and nonsteroidal anti-inflammatory drugs (NSAIDs), orthotics with medial stiffness, and reduction of great toe movement in motions such as kneeling or squatting with the toes in an extended position.



Primary Outcome Measures :
  1. Change in Active Range of Motion of Hallux (great toe) Extension [ Time Frame: Two Months ]

Secondary Outcome Measures :
  1. Change in passive Range of Motion, Extension [ Time Frame: same ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Reduced flexibility in AROM of extension in the great toe
  • Pain that is worsened by walking and/or squatting
  • Impaired gait pattern

Exclusion Criteria:

  • Metatarsal stress fracture
  • Interdigital neuroma
  • Sesamoid pathology
  • Gout
  • Metatarsalgia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00717691


Locations
United States, Georgia
Atlanta Foot and Leg Clinic
Jonesboro, Georgia, United States, 30236
Ankle and Foot Centers, PC
Marietta, Georgia, United States, 30066
Sponsors and Collaborators
Dynasplint Systems, Inc.
Investigators
Principal Investigator: Stanley R Kalish, DPM, FACFAS Atlanta Foot and Leg Clinic
Study Director: Buck Willis, PhD Dynasplint Systems, Inc.

Publications:
Willis B, John M. Dynamic Splinting Increases Flexion for Hallux Rigidus (Pilot Study). BioMechanics, 2007 Sept;14(9), pg49-53
Becher C, Kilger R, Thermann H. Results of cheilectomy and additional microfracture techniques for the treatment of hallux rigidus. Foot Ankle Surg. 2005;(10): 155-160
Willis B. Dancers restore knee flexion through dynamic splinting. BioMechanics. 2008;Jan;15(1), pg49-54

Responsible Party: Dynasplint Systems, Inc.
ClinicalTrials.gov Identifier: NCT00717691     History of Changes
Other Study ID Numbers: 2008.003
First Posted: July 17, 2008    Key Record Dates
Last Update Posted: April 30, 2012
Last Verified: April 2012

Keywords provided by Dynasplint Systems, Inc.:
Hallux Limitus
Dynamic Splinting
Dynasplint

Additional relevant MeSH terms:
Hallux Limitus
Hallux Rigidus
Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases
Joint Diseases
Foot Injuries
Leg Injuries
Wounds and Injuries