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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dynasplint Systems, Inc.
ClinicalTrials.gov Identifier:
NCT00717691
First received: July 15, 2008
Last updated: April 27, 2012
Last verified: April 2012

July 15, 2008
April 27, 2012
July 2008
October 2008   (final data collection date for primary outcome measure)
Change in Active Range of Motion of Hallux (great toe) Extension [ Time Frame: Two Months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00717691 on ClinicalTrials.gov Archive Site
Change in passive Range of Motion, Extension [ Time Frame: same ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Hallux Limitus Treated With Dynamic Splinting: A Randomized, Controlled Trial
Hallux Limitus Treated With Dynamic Splinting: A Randomized, Controlled Trial

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.

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

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.
  • Experimental: 1
    Immediate fitting with dynamic splinting following diagnosis of hallux limitus.
    Interventions:
    • Device: Metatarsophalangeal Extension Dynasplint System
    • Other: Standard of Care
  • No Intervention: 2
    Control arm; patients only treated with standard of care following diagnosis of hallux limitus.
    Intervention: Other: Standard of Care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2008
October 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00717691
2008.003
Yes
Dynasplint Systems, Inc.
Dynasplint Systems, Inc.
Not Provided
Principal Investigator: Stanley R Kalish, DPM, FACFAS Atlanta Foot and Leg Clinic
Study Director: Buck Willis, PhD Dynasplint Systems, Inc.
Dynasplint Systems, Inc.
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP