Ankle Joint ContractureNCT05844072
Effect of Mobilization With Movement on Weight Bearing Ankle Dorsiflexion Range of Motion
A study testing Mobilization with movement in people with Ankle Joint Contracture, run by University of South Carolina at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ankle Joint Contracture
- What is being tested?
- Mobilization with movement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2023to Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Blatt Physical education Building
Columbia, South Carolina, 29208
Cathy F Arnot, DPT, 803-240-2455, arnot@mailbox.sc.edu
About this study
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
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.
Read the 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).
- Conditions
- Ankle Joint Contracture
- Being tested
- Mobilization with movement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobilization with movementProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Ankle dorsiflexion range of motion with inclinometer in standing | Active comparator | 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. Receives: Procedure: Mobilization with movement |
| Weight bearing lunge test | Active comparator | 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. Receives: Procedure: Mobilization with movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after the intervention
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.
Measured: Immediatley after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study startMay 2023 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle Joint ContractureStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cathy Arnot, University of South Carolina
- Investigators
- Cathy F Arnot, DPT, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844072
- Sponsor's protocol ID
- Pro00125551
- Status last verified
- Apr 2023
- First submitted
- 24 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05844072
- Acronym / sponsor ID
- Pro00125551
- Conditions
- Ankle Joint Contracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ankle dorsiflexion range of motion with inclinometer in standing | Active comparator | Procedure: Mobilization with movementThe 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. |
| Weight bearing lunge test | Active comparator | Procedure: Mobilization with movementThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobilization with movementAll 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. | Procedure or surgery | Ankle dorsiflexion range of motion with inclinometer in standing, Weight bearing lunge test |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: No
Related trials for Ankle Joint Contracture
Not yet recruiting
Continuous Passive Motion to Prevent Ankle Contracture and Muscle Atrophy in Ventilated Patients
Ankle Contracture, Critically Ill Intensive Care Unit Patients
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cathy F Arnot, DPT principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobilization with movement in people with Ankle Joint Contracture, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cathy F Arnot, DPT (8032402455, arnot@mailbox.sc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dorsiflexion range of motion (time frame: Immediately after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.