Foot and Ankle Range of Motion (Stretching) Apparatus

Not Applicable

Terminated

• Conditions: Plantar Fasciitis; Flatfoot; Calcaneus Fractures
• Interventions: Device: Non-Measuring Ankle Exerciser

• Registration Number: NCT00527748
• Lead Sponsor: University of Missouri-Columbia

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.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-07
• Study First Submitted QC: 2007-09-07
• Study First Posted: 2007-09-11
• Primary Completion: 2011-12
• Study Completion: 2012-07
• Results First Submitted: 2016-09-21
• Status Verified: 2017-03
• Results First Submitted QC: 2017-04-19
• Last Update Submitted: 2017-04-19
• Results First Posted: 2017-04-21
• Last Update Posted: 2017-04-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-Measuring Ankle Exerciser	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.

Primary Outcome Measures

Name	Time	Method
Change in Range of Motion	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.

Trial Locations

Locations (1)

University of Missouri-Columbia Healthcare; 🇺🇸 Columbia, Missouri, United States