Foot and Ankle Range of Motion (Stretching) Apparatus

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2012-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Plantar Fasciitis Flatfoot Calcaneus Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Non-Measuring Ankle Exerciser

Intervention Type DEVICE

Stretching exercise performed 10 times per day, for six (6) weeks.

Interventions

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Non-Measuring Ankle Exerciser

Stretching exercise performed 10 times per day, for six (6) weeks.

Intervention Type DEVICE

Other Intervention Names

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Ankle Recovery Mechanism (ARM)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No