Ankle Dorsiflexion Changes With Assisted Stretching Device

NCT06343506 | Completed DMC FDA Device

• 1 other identifier: 2023-929-EXPEDITED
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Physical Therapy Modality

Outcome Measures

Primary Outcomes (1)

• Ankle Range of Motion

  Range of motion during passive and active movement.

  Following 3 Weeks of Device Use

Secondary Outcomes (1)

• Ankle Strength

  Following 3 Weeks of Device Use

Study Arms (1)

Affected Individuals

EXPERIMENTAL

Device: Grassroots Ankle Flex

Interventions

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.

Affected Individuals

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of limited ankle range of dorsiflexion by physical therapist

You may not qualify if:

• 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

Sponsors & Collaborators

• Montana State University: lead

Study Sites (1)

Neuromuscular Biomechanics Laboratory

Bozeman, Montana, 59717, United States

Location

Study Officials

• Corey Pew, PhD

  Montana State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: April 2, 2024
• Study Start: October 30, 2023
• Primary Completion: June 1, 2024
• Study Completion: December 31, 2024
• Last Updated: May 7, 2025

Record last verified: 2025-05

Locations

US (1)