Ankle Dorsiflexion Changes With Assisted Stretching Device

NCT ID: NCT06343506

Last Updated: 2025-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-30

Study Completion Date

2024-12-31

Brief Summary

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Ankle range of motion is an important degree of freedom for performing activities of daily living. Limited range of ankle motion has been related to Achilles tendonitis, lower limb injury, and abnormal gait leading to overuse injury. While stretching and massage can help increase range of motion the amount and frequency of manual manipulation needed to affect range of motion is not accessible to an individual in their home. A new device has been developed to allow deep stretching of the ankle and surrounding muscles to help increase ankle dorsiflexion. This device can be used in an individual's home, without assistance, allowing more frequent stretching without increased visits to physical therapy. The goal of this study is to determine the effect of using this device during a course of treatment to improve ankle dorsiflexion in individuals with decreased ankle range of motion.

Detailed Description

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Conditions

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Physical Therapy Modality

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Affected Individuals

Group Type EXPERIMENTAL

Grassroots Ankle Flex

Intervention Type DEVICE

This device can be used in an individual's home, without assistance, allowing more frequent stretching without increased visits to physical therapy. The Ankle Flex device is used to stretch patients into a dorsiflexion position by securing the foot to the base of the device and the shin to the leg strap attached to the pulley system. The patients can then pull the handle of the pulley system, giving them the mechanical advantage to gently mobilize their ankle into dorsiflexion with their foot firmly secured to the base of the device. This can allow for a deeper and more controlled stretch than previous stretching methods done during at home care.

Interventions

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Grassroots Ankle Flex

This device can be used in an individual's home, without assistance, allowing more frequent stretching without increased visits to physical therapy. The Ankle Flex device is used to stretch patients into a dorsiflexion position by securing the foot to the base of the device and the shin to the leg strap attached to the pulley system. The patients can then pull the handle of the pulley system, giving them the mechanical advantage to gently mobilize their ankle into dorsiflexion with their foot firmly secured to the base of the device. This can allow for a deeper and more controlled stretch than previous stretching methods done during at home care.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of limited ankle range of dorsiflexion by physical therapist

Exclusion Criteria

* Inability to perform testing activities as described in the consent form by self-report
* Inability to perform daily stretching with the device by self-report
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Montana State University

OTHER

Sponsor Role lead

Responsible Party

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Corey Alexander Pew

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Corey Pew, PhD

Role: PRINCIPAL_INVESTIGATOR

Montana State University

Locations

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Neuromuscular Biomechanics Laboratory

Bozeman, Montana, United States

Site Status

Countries

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United States

Other Identifiers

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2023-929-EXPEDITED

Identifier Type: -

Identifier Source: org_study_id

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