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OpenTrials
Completed

NCT Number: NCT06343506

Ankle Dorsiflexion Changes With Assisted Stretching Device

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.

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Key information

Conditions

Physical Therapy Modality

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neuromuscular Biomechanics Laboratory

Bozeman, Montana, 59717, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Grassroots Ankle Flex

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.

Primary outcomes

  1. Ankle Range of Motion

    Time frame: Following 3 Weeks of Device Use

    Range of motion during passive and active movement.

Secondary outcomes

  1. Ankle Strength

    Time frame: Following 3 Weeks of Device Use

    Strength in dorsiflexion

Sponsors and collaborators

Lead sponsor

Montana State University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 2, 2024
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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