NCT07849374

Brief Summary

This randomized controlled trial evaluates the effects and clinical specificity of Mulligan Mobilization With Movement (MWM) in adults with grade I or II lateral ankle sprains occurring less than 6 weeks before enrollment. The primary study population consists of participants enrolled within 2 weeks of the index lateral ankle sprain. Participants with an injury occurring between 2 and less than 6 weeks before enrollment are also eligible. Approximately 110 participants will be allocated to a Mulligan MWM intervention group or a control group receiving usual-care rehabilitation without Mulligan treatment. In the intervention group, three MWM techniques targeting the inferior tibiofibular, talocrural, and cubometatarsal joints are tested in a randomized order and adapted according to the participant's immediate pain-free response. Treatment includes up to six sessions provided twice weekly. Clinical outcomes are assessed at baseline, 3 weeks, and 3 months. The primary outcomes are ankle dorsiflexion range of motion, ankle joint arthrokinematics, and pain during weight-bearing dorsiflexion.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Jan 2025Mar 2027

Study Start

First participant enrolled

January 1, 2025

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 30, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2027

Last Updated

September 30, 2026

Status Verified

September 1, 2026

Enrollment Period

2 years

First QC Date

September 24, 2026

Last Update Submit

September 24, 2026

Conditions

Keywords

Acute Lateral Ankle SprainMulligan Mobilization With MovementManual TherapyAnkle DorsiflexionWeight-Bearing Lunge TestPosterior Talar GlideFoot and Ankle Ability MeasureAnkle Rehabilitation

Outcome Measures

Primary Outcomes (3)

  • Ankle Dorsiflexion Range of Motion Measured With the Weight-Bearing Lunge Test

    Ankle dorsiflexion range of motion is measured in centimeters (hallux-to-wall distance) and degrees (tibial inclination) using the Weight-Bearing Lunge Test performed against a wall. Higher values indicate greater weight-bearing ankle dorsiflexion.

    Throughout the entire study, during approximately 24 months

  • Posterior talar glide range of motion

    Posterior talar glide range of motion is assessed using the Posterior Talar Glide Test (tibial inclination in degrees). Higher values indicate greater posterior talar glide range of motion.

    Throughout the entire study, during approximately 24 months

  • Patient-Reported Sensations During the Weight-Bearing Lunge Test

    Patient-reported sensations are assessed using the Weight-Bearing Lunge Test sensory-mapping process. During the end-range Weight-Bearing Lunge Test position, participants report the type(s) and anatomical localization(s) of the sensation(s) perceived.

    Throughout the entire study, during approximately 24 months

Secondary Outcomes (14)

  • Static Postural Control During Single-Leg Stance

    Throughout the entire study, during approximately 24 months

  • Dynamic postural control using the Modified Y-Balance Test

    Throughout the entire study, during approximately 24 months

  • Eversion strength

    Throughout the entire study, during approximately 24 months

  • Inversion strength

    Throughout the entire study, during approximately 24 months

  • Dorsiflexion strength

    Throughout the entire study, during approximately 24 months

  • +9 more secondary outcomes

Study Arms (2)

Mulligan Mobilization With Movement

EXPERIMENTAL

Participants receive Mulligan Mobilization With Movement for lateral ankle sprain. Three MWM techniques targeting the inferior tibiofibular, talocrural, and cubometatarsal joints are tested according to a randomized sequence. Treatment is adapted according to the participant's immediate pain-free response. Treatment is provided for up to six 15-minute sessions, twice weekly, and may be stopped earlier if symptoms resolve.

Other: Mulligan Mobilization With MovementOther: Usual-Care Rehabilitation for Lateral Ankle Sprain

Usual-Care Rehabilitation

ACTIVE COMPARATOR

Participants receive usual-care rehabilitation for lateral ankle sprain without Mulligan Concept treatment. The rehabilitation provided by the treating physiotherapist is documented during the study.

Other: Usual-Care Rehabilitation for Lateral Ankle Sprain

Interventions

A physiotherapist trained in the Mulligan Concept applies Mobilization With Movement while the participant actively performs ankle dorsiflexion. Three techniques targeting the inferior tibiofibular, talocrural, and cubometatarsal joints are tested according to a randomized sequence. The intervention is performed without pain and is evaluated for an immediate response. According to the protocol, an immediate clinically relevant response is defined as a 2-point improvement in pain on the numerical rating scale or an improvement greater than 1.9 cm in ankle dorsiflexion measured with the Weight-Bearing Lunge Test. If the response criterion is not met, the next MWM technique in the randomized sequence is tested. Up to six treatment sessions are provided twice weekly.

Mulligan Mobilization With Movement

Participants receive traditional rehabilitation for lateral ankle sprain without Mulligan Mobilization With Movement. Rehabilitation is adapted to the participant's clinical presentation and is documented by the treating physiotherapist.

Mulligan Mobilization With MovementUsual-Care Rehabilitation

Eligibility Criteria

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

You may qualify if:

  • Grade I or II lateral ankle sprain Index lateral ankle sprain occurring less than 6 weeks before enrollment Age 18 years or older No fracture associated with the index lateral ankle sprain No immobilization in a plaster cast Able to provide written informed consent

You may not qualify if:

  • Grade III lateral ankle sprain Index lateral ankle sprain occurring 6 weeks or more before enrollment Additional lower-limb musculoskeletal disorder or injury incompatible with study participation Neurological disorder Severe hypertension Renal disease Cardiorespiratory disorder Sickle cell disease Arterial calcification Varicose veins Current anticoagulant treatment Current risk of or history of deep-vein thrombosis Fragile skin Previous surgery affecting sports performance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FYKI Sports

Gistoux, Chaumont-Gistoux, 1325, Belgium

RECRUITING

Related Publications (4)

  • Powden CJ, Hoch JM, Hoch MC. Reliability and minimal detectable change of the weight-bearing lunge test: A systematic review. Man Ther. 2015 Aug;20(4):524-32. doi: 10.1016/j.math.2015.01.004. Epub 2015 Jan 29.

    PMID: 25704110BACKGROUND
  • Picot B, Lopes R, Rauline G, Fourchet F, Hardy A. Development and Validation of the Ankle-GO Score for Discriminating and Predicting Return-to-Sport Outcomes After Lateral Ankle Sprain. Sports Health. 2024 Jan-Feb;16(1):47-57. doi: 10.1177/19417381231183647. Epub 2023 Jul 11.

    PMID: 37434508BACKGROUND
  • Delahunt E, Bleakley CM, Bossard DS, Caulfield BM, Docherty CL, Doherty C, Fourchet F, Fong DT, Hertel J, Hiller CE, Kaminski TW, McKeon PO, Refshauge KM, Remus A, Verhagen E, Vicenzino BT, Wikstrom EA, Gribble PA. Clinical assessment of acute lateral ankle sprain injuries (ROAST): 2019 consensus statement and recommendations of the International Ankle Consortium. Br J Sports Med. 2018 Oct;52(20):1304-1310. doi: 10.1136/bjsports-2017-098885. Epub 2018 Jun 9.

    PMID: 29886432BACKGROUND
  • Nguyen AP, Pitance L, Mahaudens P, Detrembleur C, David Y, Hall T, Hidalgo B. Effects of Mulligan Mobilization with Movement in Subacute Lateral Ankle Sprains: A Pragmatic Randomized Trial. J Man Manip Ther. 2021 Dec;29(6):341-352. doi: 10.1080/10669817.2021.1889165. Epub 2021 Feb 26.

MeSH Terms

Interventions

Movement

Intervention Hierarchy (Ancestors)

Physiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Anh Phong Nguyen, PhD

    CIRRIS ULaval

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants and outcome assessors are blinded to treatment allocation. Participants are not informed whether they are assigned to the Mulligan Mobilization With Movement intervention group or the control group. Outcome assessors performing the clinical measurements are blinded to treatment allocation and do not participate in treatment delivery. Treating physiotherapists are not blinded because they deliver the allocated intervention. They have access to the clinical assessment results to guide the individualized background rehabilitation provided to participants in both groups.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are randomized in parallel to a Mulligan Mobilization With Movement intervention group or a usual-care rehabilitation control group. Within the Mulligan intervention group, the order in which three MWM techniques are tested is also randomized.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2026

First Posted

September 30, 2026

Study Start

January 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 30, 2027

Last Updated

September 30, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Individual participant data are not planned to be made publicly available or routinely shared with external researchers. Study data will be handled in accordance with the study protocol, informed consent, applicable data protection regulations, and UCLouvain institutional requirements.

Locations