NCT01589679TerminatedNot Applicable
Contracture Reduction Following Bunionectomy: a Longitudinal, Controlled Trial
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Dynasplint Systems, Inc.
- Enrollment
- 40
- Locations
- 6
- Primary Endpoint
- A Repeated Measures Analysis of Variance (ANOVA)
Study Overview
Brief Summary
To determine the efficacy of Metatarsal Dynasplint Sytem (MTP) in reducing contracture of hallux limitus secondary to Bunionectomy, in a longitudinal, controlled trial.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis 1st MTJ Contracture following Bunionectomy
Exclusion Criteria
- •Current treatment with Botulinium Toxin-A (Botox), lower extremity
- •Current treatment Fluoroquinolones (antibiotic medication)
- •Current use of muscle relaxant medications
- •Fibromyalgia
- •Stroke, CVA, Brain Injury, Spinal Cord Injury, or any neural pathology causing plasticity or hypertonicity
- •Treatment with electrical stimulation assisting ambulation (i.e Bioness, WalkAide, Parastep, etc.)
Outcomes
Primary Outcomes
A Repeated Measures Analysis of Variance (ANOVA)
Time Frame: 12 months
ANOVA will be performed to measure different in category, pain, duration to full restoration of active range of motion(AROM).
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (6)
Loading locations...
Similar Trials
Completed
Not Applicable
Hallux Limitus Treated With Dynamic Splinting: A Randomized, Controlled TrialHallux LimitusNCT00717691Dynasplint Systems, Inc.50
Withdrawn
Not Applicable
Dynamic Splinting for Plantarflexion in Spastic HemiplegiaSpastic HemiplegiaNCT01329705Dynasplint Systems, Inc.
Unknown
Not Applicable
Dynasplint for Distal Radius FractureDistal Radius FractureNCT01032356Dynasplint Systems, Inc.50
Completed
Not Applicable
Stabilometry and Plantar Pressures Changes After Dry Needling in Flexor Digitoum Brevis.HealthyFootDry NeedlingNCT04222946Mayuben Private Clinic18
Unknown
Not Applicable
A Study on the Treatment of Recurrent Clubfoot With the Tendon Release of Musculi Tibialis PosteriorRecurrent ClubfootNCT04212663Guangzhou Women and Children's Medical Center80