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CompletedNCT06343506Updated May 7, 2025

Ankle Dorsiflexion Changes With Assisted Stretching Device

An interventional study of Grassroots Ankle Flex in Physical Therapy Modality, sponsored by Montana State University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-07.

Sponsored by Montana State University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was Jun 2024, 2 years 4 months ago, and no results have been posted to the registry.
  • Registered 4 months after the study started (first participant enrolled Oct 2023, registered Mar 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Physical Therapy Modality
03

In context

Lead sponsor

Montana State University is the lead sponsor of 41 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of limited ankle range of dorsiflexion by physical therapist

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    Affected Individuals

    Device: Grassroots Ankle Flex

Interventions

  • DeviceGrassroots 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.

06

What researchers measure

Primary outcomes

  1. Ankle Range of Motion

    Range of motion during passive and active movement.

    Time frame: Following 3 Weeks of Device Use

Secondary outcomes

  1. Ankle Strength

    Strength in dorsiflexion

    Time frame: Following 3 Weeks of Device Use

07

Study locations

1 site
  • Neuromuscular Biomechanics Laboratory
    Bozeman, Montana 59717, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06343506
Lead sponsor
Montana State University
Responsible party
Corey Alexander Pew (Assistant Professor, Montana State University) — Principal investigator
First posted
Apr 2, 2024
Start date
Oct 30, 2023
Primary completion
Jun 1, 2024
Completion
Dec 31, 2024
Last update
May 7, 2025

Study contacts

Corey Pew, PhD
principal investigator · Montana State University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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