Foot and Ankle Range of Motion (Stretching) Apparatus

Plantar Fasciitis Clinical Trial

Official title:

The Use of a New Foot and Ankle Range of Motion (Stretching) Apparatus in Subjects With Stiff Ankles

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00527748
• Other study ID #: 1092357
• Status: Terminated
• Phase: N/A
• First received: September 7, 2007
• Last updated: April 19, 2017
• Start date: September 2007
• Est. completion date: July 2012

Study information

• Verified date: March 2017
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: July 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Calcaneus Fractures
• Fasciitis
• Fasciitis, Plantar
• Flatfoot
• Plantar Fasciitis

Intervention

Device:
• Non-Measuring Ankle Exerciser
Stretching exercise performed 10 times per day, for six (6) weeks.

Locations

Country	Name	City	State
United States	University of Missouri-Columbia Healthcare	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Ten weeks