NCT05844072

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

May 6, 2023

Status Verified

April 1, 2023

Enrollment Period

6 months

First QC Date

April 24, 2023

Last Update Submit

April 24, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

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.

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.

Procedure: Mobilization with movement

Interventions

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.

Ankle dorsiflexion range of motion with inclinometer in standingWeight bearing lunge test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Blatt Physical education Building

Columbia, South Carolina, 29208, United States

RECRUITING

MeSH Terms

Interventions

Movement

Intervention Hierarchy (Ancestors)

Physiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Cathy F Arnot, DPT

    University of South Carolina

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cathy F Arnot, DPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The investigator setting up the goniometer will be masked to the outcome measures
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 24, 2023

First Posted

May 6, 2023

Study Start

May 1, 2023

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

May 6, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations