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Foot and Ankle Range of Motion (Stretching) Apparatus

This study is currently recruiting participants.
Verified July 2011 by University of Missouri-Columbia
Sponsor:
Information provided by:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00527748
First received: September 7, 2007
Last updated: July 11, 2011
Last verified: July 2011
History of Changes
  Purpose

Range of motion at ankle joint and subtalar joint will be assessed before and after utilization of ARM device. The changes in range of motion will be recorded and compared to literature.


Condition Intervention
Plantar Fasciitis
Flatfoot
Calcaneus Fractures
 Device: Non-Measuring Ankle Exerciser (Ankle Recovery Mechanism)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of a New Foot and Ankle Range of Motion (Stretching) Apparatus in Subjects With Stiff Ankles

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • Participants randomized into ARM stretching device group will experience less ankle stiffness and an increased range of motion after using the stretching device, as compared to the control group receiving traditional physiotherapy. [ Time Frame: Ten weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2007
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Group A
Patient ankle range of motion will be assessed at clinic visit. No stretching exercises with the device, but will be provided standard care through physiotherapist in acute cases, and no stretching exercises for chronic patients. Reassessment will be done at six weeks and 10 weeks.
Experimental: Group B Stretching
Subjects will train using only one combination of movement, dorsiflexion with inversion. This is done by manipulating the ring so that the medial and anterior ropes are taut. Subject will start with 3 minute warm-up. Subject will then manipulate the ring so that the foot moves into dorsiflexion with inversion until a point of tolerable discomfort is felt; subject will hold this position for 30 seconds. Stretch will be repeated 10 times, each day, for six weeks. Reassessment will be done at six weeks and 10 weeks.
 Device: Non-Measuring Ankle Exerciser (Ankle Recovery Mechanism)
Stretching exercise performed 10 times per day, for six (6) weeks.
Other Name: Ankle Recovery Mechanism (ARM)

Detailed Description:

The purpose of this study is to assess how effective a new device is in increasing range of motion and reducing stiffness in the foot and ankle of patients with acquired flatfoot, patients with plantar fasciitis, and those suffering from stiffness after cast removal or other lengthy immobilization.

Project will utilize a physical therapist to measure range of motion and stiffness when patients are consented. Patients will be re-measured at six weeks following use of the device to assist in stretching ankle and foot muscles, and again at 10 weeks for final stiffness and range of motion assessment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • stiffness in or about the ankle joint due to age, diabetes, trauma, flatfoot, plantar fasciitis, or immobilization

Exclusion Criteria:

  • not physically able to use device
  • patients with pain disorders
  • patients lacking necessary hand-eye coordination
  • patients using lower extremity external fixator
  • patients with history of non-compliance
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00527748

Locations
United States, Missouri
University of Missouri-Columbia Healthcare Recruiting
Columbia, Missouri, United States, 65212
Contact: Saul G Trevino, MD     573-882-6708     trevinos@health.missouri.edu    
Principal Investigator: Saul G Trevino, MD            
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Saul G Trevino, MD University of Missouri-Columbia School of Medicine
  More Information

No publications provided

Responsible Party: Saul G. Trevino, MD, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT00527748     History of Changes
Other Study ID Numbers: 1092357
Study First Received: September 7, 2007
Last Updated: July 11, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Missouri-Columbia:
Range of Motion
Ankle Fractures
Elderly patients

Additional relevant MeSH terms:
Fasciitis
Flatfoot
Fractures, Bone
Fasciitis, Plantar
 Musculoskeletal Diseases
Foot Deformities
Wounds and Injuries
Foot Diseases

ClinicalTrials.gov processed this record on May 21, 2013