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Foot and Ankle Range of Motion (Stretching) Apparatus

Primary Purpose

Plantar Fasciitis, Flatfoot, Calcaneus Fractures

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Non-Measuring Ankle Exerciser
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fasciitis focused on measuring Range of Motion, Ankle Fractures, Elderly patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Missouri-Columbia Healthcare

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of care

Non-Measuring Ankle Exerciser

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Range of Motion
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.

Secondary Outcome Measures

Full Information

First Posted
September 7, 2007
Last Updated
April 19, 2017
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT00527748
Brief Title
Foot and Ankle Range of Motion (Stretching) Apparatus
Official Title
The Use of a New Foot and Ankle Range of Motion (Stretching) Apparatus in Subjects With Stiff Ankles
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
Investigator left institution. No data analysis completed.
Study Start Date
September 2007 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fasciitis, Flatfoot, Calcaneus Fractures
Keywords
Range of Motion, Ankle Fractures, Elderly patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
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.
Arm Title
Non-Measuring Ankle Exerciser
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Non-Measuring Ankle Exerciser
Other Intervention Name(s)
Ankle Recovery Mechanism (ARM)
Intervention Description
Stretching exercise performed 10 times per day, for six (6) weeks.
Primary Outcome Measure Information:
Title
Change in Range of Motion
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saul G Trevino, MD
Organizational Affiliation
University of Missouri-Columbia School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri-Columbia Healthcare
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Foot and Ankle Range of Motion (Stretching) Apparatus

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