- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05844072
Effect of Mobilization With Movement on Weight Bearing Ankle Dorsiflexion Range of Motion
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 Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Cathy F Arnot, DPT
- Phone Number: 8032402455
- Email: arnot@mailbox.sc.edu
Study Locations
-
-
South Carolina
-
Columbia, South Carolina, United States, 29208
- Recruiting
- Blatt Physical education Building
-
Contact:
- Cathy F Arnot, DPT
- Phone Number: 803-240-2455
- Email: arnot@mailbox.sc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Ankle dorsiflexion range of motion with inclinometer in standing
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.
|
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.
|
|
Active Comparator: 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 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dorsiflexion range of motion
Time Frame: Immediately after the intervention
|
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
|
|
Weight bearing lunge test
Time Frame: Immediatley after intervention
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00125551
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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