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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05844072
Other study ID # Pro00125551
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 2023
Est. completion date November 2023

Study information

Verified date April 2023
Source University of South Carolina
Contact Cathy F Arnot, DPT
Phone 8032402455
Email arnot@mailbox.sc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Limited ankle range of motion is associated with increased risk for ankle sprains, knee joint dysfunction and injury to the ACL. Therefore, it is important that researchers and clinicians understand the best treatment options to increase ankle range of motion for injury prevention. We are recruiting adults with limited ankle range of motion who are lacking current ankle injuries for a treatment investigation. All study procedures will occur on the campus of the University of South Carolina by a licensed Physical Therapist and experienced researcher.


Description:

All participants will receive the MWM intervention with weight bearing ankle dorsiflexion range of motion measured prior to the intervention, immediately following the intervention, and 24 hours (+/- 3 hours) following the intervention. The participant will first place their foot on a 16-inch box to assist in performance of the intervention by the therapist. A licensed physical therapist (PT) will then stabilize the talus for a proper joint mobilization to be performed. The therapist will then mobilize the distal tib/fib in the posterior to anterior direction at end range DF reached through a forward lunge, using a Mulligan's mobilization belt around the distal tibia-fibula. The participant will perform 3 sets of 10 repetitions of the forward lunge and the PT will perform a bout of overpressure at end range during each repetition. Two other investigators will be on either side of participant to assist with balance during the intervention if needed. Weight bearing ankle dorsiflexion range of motion will be measured via a primary and secondary measure. The primary measurement will be use of a bubble inclinometer and the secondary measurement will be the standing ankle dorsiflexion screen (SADS).


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date November 2023
Est. primary completion date November 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - The sole inclusion criterion will be a limitation in active ankle dorsiflexion range of motion to less than 20 degrees in weight bearing in one or both ankles. Exclusion Criteria: - Exclusion criteria include self identified feelings of ankle instability or known diagnosis of chronic ankle instability, dermatologic conditions such as open wounds or impaired sensation which inhibit the ability to use the mobilization strap, and inability to get into the testing position or perform a lunge during the intervention.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Mobilization with movement
All participants will receive the MWM intervention with weight bearing ankle dorsiflexion range of motion measured prior to the intervention, immediately following the intervention, and 24 hours (+/- 3 hours) following the intervention. The participant will first place their foot on a 16-inch box to assist in performance of the intervention by the therapist. A licensed physical therapist (PT) will then stabilize the talus for a proper joint mobilization to be performed. The therapist will then mobilize the distal tib/fib in the posterior to anterior direction at end range DF reached through a forward lunge, using a Mulligan's mobilization belt around the distal tibia-fibula. The participant will perform 3 sets of 10 repetitions of the forward lunge and the PT will perform a bout of overpressure at end range during each repetition. Two other investigators will be on either side of participant to assist with balance during the intervention if needed.

Locations

Country Name City State
United States Blatt Physical education Building Columbia South Carolina

Sponsors (1)

Lead Sponsor Collaborator
University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dorsiflexion range of motion The measurement will then be taken using the inclinometer placed at 15 cm below the tibial tuberosity. The examiner stabilizing the heel will hold the inclinometer in place, while another examiner ensures proper placement of the inclinometer and takes the reading. Immediately after the intervention
Primary Weight bearing lunge test The Weight Bearing Lunge Test (WBLT) will be used to measure closed chain dorsiflexion in participants. A bubble inclinometer will be placed 15 cm below the tibial tuberosity for measurement during the WBLT. Participants will place their foot on a line on the floor which is perpendicular to the wall to help maintain alignment. The measurement will then be taken using the inclinometer placed at 15 cm below the tibial tuberosity. The examiner stabilizing the heel will hold the inclinometer in place, while another examiner ensures proper placement of the inclinometer and takes the reading. The WBLT will be completed twice and the average of the two measurements will be taken. Immediatley after intervention
See also
  Status Clinical Trial Phase
Completed NCT03068338 - Robotic Sock Technology for Prevention of Deep Vein Thrombosis and Joint Contracture N/A
Recruiting NCT03171233 - Immediate Effects of Two Ankle Mobilization Techniques in the Amplitude of Dorsiflexion and Dynamic Valgus Knee N/A