Clinical trial NCT00717691: Hallux Limitus Treated With Dynamic Splinting: A Randomized, Controlled Trial
Official title: Hallux Limitus Treated With Dynamic Splinting: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hallux Limitus
Keywords: Hallux Limitus
Dynamic Splinting
Dynasplint
Lead sponsor: Dynasplint Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2008-07-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Eligibility 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

Primary outcomes:
measure: Change in Active Range of Motion of Hallux (great toe) Extension
timeFrame: Two Months
Secondary outcomes:
measure: Change in passive Range of Motion, Extension
timeFrame: same
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: Atlanta Foot and Leg Clinic
state: Georgia
city: Marietta
country: United States
facility: Ankle and Foot Centers, PC
state: Georgia
Study officials:
affiliation: Atlanta Foot and Leg Clinic
name: Stanley R Kalish, DPM, FACFAS
role: PRINCIPAL_INVESTIGATOR
affiliation: Dynasplint Systems, Inc.
name: Buck Willis, PhD
role: STUDY_DIRECTOR
References:
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citation: Willis B, John M. Dynamic Splinting Increases Flexion for Hallux Rigidus (Pilot Study). BioMechanics, 2007 Sept;14(9), pg49-53
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citation: Canseco K, Long J, Marks R, Khazzam M, Harris G. Quantitative characterization of gait kinematics in patients with hallux rigidus using the Milwaukee foot model. J Orthop Res. 2008 Apr;26(4):419-27. doi: 10.1002/jor.20506.
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citation: Willis B. Dancers restore knee flexion through dynamic splinting. BioMechanics. 2008;Jan;15(1), pg49-54