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Foot and Ankle Range of Motion (Stretching) Apparatus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00527748
Recruitment Status : Terminated (Investigator left institution. No data analysis completed.)
First Posted : September 11, 2007
Results First Posted : April 21, 2017
Last Update Posted : April 21, 2017
Sponsor:
Information provided by (Responsible Party):
University of Missouri-Columbia

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Plantar Fasciitis Flatfoot Calcaneus Fractures Device: Non-Measuring Ankle Exerciser Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : September 2007
Actual Primary Completion Date : December 2011
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Standard of care
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: Non-Measuring Ankle Exerciser
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
Stretching exercise performed 10 times per day, for six (6) weeks.
Other Name: Ankle Recovery Mechanism (ARM)


Outcome Measures
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Primary Outcome Measures :
  1. Change in Range of Motion [ Time Frame: Ten weeks ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT00527748


Locations
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United States, Missouri
University of Missouri-Columbia Healthcare
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
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Principal Investigator: Saul G Trevino, MD University of Missouri-Columbia School of Medicine
More Information
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Responsible Party: University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT00527748    
Other Study ID Numbers: 1092357
First Posted: September 11, 2007    Key Record Dates
Results First Posted: April 21, 2017
Last Update Posted: April 21, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Missouri-Columbia:
Range of Motion
Ankle Fractures
Elderly patients
Additional relevant MeSH terms:
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Fasciitis
Fasciitis, Plantar
Flatfoot
Musculoskeletal Diseases
Foot Diseases
Talipes
Foot Deformities, Acquired
 Foot Deformities
Foot Deformities, Congenital
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities