Foot and Ankle Range of Motion (Stretching) Apparatus
|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
|Condition or disease||Intervention/treatment||Phase|
|Plantar Fasciitis Flatfoot Calcaneus Fractures||Device: Non-Measuring Ankle Exerciser||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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)
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00527748
|United States, Missouri|
|University of Missouri-Columbia Healthcare|
|Columbia, Missouri, United States, 65212|
|Principal Investigator:||Saul G Trevino, MD||University of Missouri-Columbia School of Medicine|