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Effect of Mobilization With Movement on Weight Bearing Ankle Dorsiflexion Range of Motion

Primary Purpose

Ankle Joint Contracture

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobilization with movement
Sponsored by
University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Joint Contracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Blatt Physical education BuildingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ankle dorsiflexion range of motion with inclinometer in standing

Weight bearing lunge test

Arm Description

The Standing Ankle Dorsiflexion Screen (SADS) will be used as a categorical outcome measure which is a more functional way to measure ankle dorsiflexion and does not require the use of additional equipment. The participant will be instructed to stand in tandem stance, one foot directly in front of the other, and bend both knees as far as they can while keeping their heel in contact with the ground. The examiner will then use a ruler to align the posterior knee with the medial malleolus and determine the position of behind, within, or in front of the malleolus.

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 participant's heel will be stabilized by an examiner, and they will then be instructed to lunge forward so that their knee reaches a vertical line on the wall. 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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 24, 2023
Last Updated
April 24, 2023
Sponsor
University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT05844072
Brief Title
Effect of Mobilization With Movement on Weight Bearing Ankle Dorsiflexion Range of Motion
Official Title
The Effect of Mobilization With Movement (MWM) on Weight Bearing Ankle Dorsiflexion (DF) Range of Motion in Individuals With Limited DF Range of Motion
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Joint Contracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Masking Description
The investigator setting up the goniometer will be masked to the outcome measures
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ankle dorsiflexion range of motion with inclinometer in standing
Arm Type
Active Comparator
Arm Description
The Standing Ankle Dorsiflexion Screen (SADS) will be used as a categorical outcome measure which is a more functional way to measure ankle dorsiflexion and does not require the use of additional equipment. The participant will be instructed to stand in tandem stance, one foot directly in front of the other, and bend both knees as far as they can while keeping their heel in contact with the ground. The examiner will then use a ruler to align the posterior knee with the medial malleolus and determine the position of behind, within, or in front of the malleolus.
Arm Title
Weight bearing lunge test
Arm Type
Active Comparator
Arm Description
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 participant's heel will be stabilized by an examiner, and they will then be instructed to lunge forward so that their knee reaches a vertical line on the wall. 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.
Intervention Type
Procedure
Intervention Name(s)
Mobilization with movement
Intervention 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.
Primary Outcome Measure Information:
Title
Dorsiflexion range of motion
Description
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.
Time Frame
Immediately after the intervention
Title
Weight bearing lunge test
Description
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.
Time Frame
Immediatley after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cathy F Arnot, DPT
Phone
8032402455
Email
arnot@mailbox.sc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cathy F Arnot, DPT
Organizational Affiliation
University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Blatt Physical education Building
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cathy F Arnot, DPT
Phone
803-240-2455
Email
arnot@mailbox.sc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Mobilization With Movement on Weight Bearing Ankle Dorsiflexion Range of Motion

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