Lateral Ankle SprainNCT07849374
Mulligan Mobilization With Movement for Acute Lateral Ankle Sprains
A study testing Mulligan Mobilization With Movement and Usual-Care Rehabilitation for Lateral Ankle Sprain in people with Lateral Ankle Sprain, run by Université Catholique de Louvain at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lateral Ankle Sprain
- What is being tested?
- Mulligan Mobilization With Movement and Usual-Care Rehabilitation for Lateral Ankle Sprain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2025to 30 Mar 2027
- Phase
- Interventional
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
FYKI Sports
Gistoux, Chaumont-Gistoux, 1325
Hugo Bogaerts PhD Student, MSc, +32473954283 ext. +32, hugo.bogaerts@uclouvain.be
Chloé Galerne MSc, MSc, +32479500769 ext. +32, chloegalernekine@gmail.com
About this study
Official title: Unravelling the Specificity of Mulligan Mobilization With Movement on Acute Lateral Ankle Sprains: A Randomized Controlled Trial
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.
Read the detailed description
This prospective pragmatic randomized controlled trial investigates the effects and clinical specificity of Mulligan Mobilization With Movement techniques 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 enrolled between 2 and less than 6 weeks after the index injury are also eligible.
Participants undergo a standardized clinical assessment including ankle dorsiflexion range of motion, pain during weight-bearing dorsiflexion, ankle joint arthrokinematics, static and dynamic balance, ankle muscle strength, self-reported foot and ankle function, and peripheral neurodynamic sensitivity.
Participants allocated to the intervention group receive Mulligan Mobilization With Movement delivered by physiotherapists trained in the Mulligan Concept. Three MWM techniques targeting the inferior tibiofibular, talocrural, and cubometatarsal joints are tested according to a randomized sequence. Treatment follows the Mulligan pain-free immediate-response principle. If the response criterion is not met with the first technique, the next technique in the randomized sequence is tested. Participants allocated to the control group receive usual-care rehabilitation for lateral ankle sprain without Mulligan Concept treatment.
Treatment is provided for up to six sessions, twice weekly. Outcome measures are collected at baseline, 3 weeks, and 3 months after enrollment.
- Conditions
- Lateral Ankle Sprain
- Being tested
- Mulligan Mobilization With Movement, Usual-Care Rehabilitation for Lateral Ankle Sprain
- Keywords
- Acute Lateral Ankle Sprain, Mulligan Mobilization With Movement, Manual Therapy, Ankle Dorsiflexion, Weight-Bearing Lunge Test, Posterior Talar Glide, Foot and Ankle Ability Measure, Ankle Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mulligan Mobilization With MovementOther
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.
Usual-Care Rehabilitation for Lateral Ankle SprainOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Mulligan Mobilization With Movement; Other: 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. Receives: Other: Usual-Care Rehabilitation for Lateral Ankle Sprain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Throughout the entire study, during approximately 24 months
Secondary outcomes (14)
Static Postural Control During Single-Leg Stance
Static postural control is assessed during a 20-second single-leg stance task by counting balance errors. The test is performed under two surface conditions: a stable surface and an unstable foam surface (Airex). A higher number of errors indicates poorer static postural control.
Measured: Throughout the entire study, during approximately 24 months
Dynamic postural control using the Modified Y-Balance Test
Dynamic postural control is assessed using the modified Y-Balance Test. Reach performance is measured in the anterior, posteromedial, and posterolateral directions and expressed in centimeters.
Measured: Throughout the entire study, during approximately 24 months
Eversion strength
Eversion strength is measured in Newtons using a hand-held dynamometer.
Measured: Throughout the entire study, during approximately 24 months
Inversion strength
Inversion strength is measured in Newtons using a hand-held dynamometer.
Measured: Throughout the entire study, during approximately 24 months
Dorsiflexion strength
Dorsiflexion strength is measured in Newtons using a hand-held dynamometer.
Measured: Throughout the entire study, during approximately 24 months
Plantar Flexor Endurance Assessed With the Heel Raise Test
Plantar flexor endurance is assessed using the single-leg Heel Raise Test recorded with the Calf Raise application.
Measured: Throughout the entire study, during approximately 24 months
Foot and Ankle Ability Measure Score
Self-reported foot and ankle function is assessed using the Foot and Ankle Ability Measure (FAAM Activities of Daily Living Subscale Score and FAAM Sports Subscale Score).
Measured: Throughout the entire study, during approximately 24 months
Fibular Nerve Neurodynamic Test Angle
Peripheral neurodynamic sensitivity is assessed in degrees using a fibular nerve straight leg raise test.
Measured: Throughout the entire study, during approximately 24 months
Side Hop Test Performance
Functional hopping performance is assessed using the Side Hop Test. Participants hop laterally and medially as fast as possible for 10 repetitions between two parallel lines positioned 30 cm apart. The first hop is performed toward the lateral side. Performance is recorded as the time required to complete the test, in seconds. Feelings of ankle instability during the task are also recorded.
Measured: Throughout the entire study, during approximately 24 months
Figure-of-8 Hop Test Performance
Functional hopping performance is assessed using the Figure-of-8 Hop Test. Participants complete two consecutive figure-of-eight laps around two posts positioned 5 m apart, corresponding to a total distance of 20 m, as fast as possible. Performance is recorded as the time required to complete the test, in seconds. Feelings of ankle instability during the task are also recorded.
Measured: Throughout the entire study, during approximately 24 months
Ankle-GO Score
Overall functional recovery and readiness to return to sport are assessed using the Ankle-GO composite score. The score integrates functional performance tests and patient-reported outcome measures, including single-leg stance, modified Star Excursion Balance Test, Side Hop Test, Figure-of-8 Hop Test, Foot and Ankle Ability Measure activities of daily living and sport subscales, and the Ankle Ligament Reconstruction-Return to Sport after Injury questionnaire. The total score ranges from 0 to 25 points, with higher scores indicating better functional status and greater readiness to return to sport.
Measured: Throughout the entire study, during approximately 24 months
Ankle Joint Swelling Measured With the Figure-of-Eight Method
Ankle joint swelling is quantified using the figure-of-eight measurement method. A tape measure is positioned around standardized anatomical landmarks of the ankle and foot following a figure-of-eight path. The resulting circumference is recorded in centimeters, with higher values indicating greater ankle swelling.
Measured: Throughout the entire study, during approximately 24 months
Psychological Readiness to Return to Sport Assessed With the ALR-RSI
Psychological readiness to return to sport is assessed using the Ankle Ligament Reconstruction-Return to Sport after Injury questionnaire (ALR-RSI). The questionnaire contains 12 items scored from 0 to 10, with 0 indicating no confidence and 10 indicating full confidence. The total score is converted to a percentage, with higher scores indicating greater psychological readiness to return to sport.
Measured: Throughout the entire study, during approximately 24 months
Perceived Ankle Instability Assessed With the Cumberland Ankle Instability Tool
Perceived ankle instability is assessed using the Cumberland Ankle Instability Tool (CAIT), a patient-reported questionnaire evaluating symptoms and functional ankle instability. The total score ranges from 0 to 30 points, with higher scores indicating better perceived ankle stability and lower scores indicating greater ankle instability.
Measured: Throughout the entire study, during approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start1 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lateral Ankle SprainStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Collaborators
- The Mulligan Concept Teachers Association (MCTA) : 2023 Mulligan Concept Award (Grant).
- Responsible party
- Sponsor
- Investigators
- Anh Phong Nguyen, PhD, Principal investigator, CIRRIS ULaval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849374
- Sponsor's protocol ID
- MULLIGAN
- Other IDs
- B4032024000105
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 25704110Picot 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.
PubMed 37434508Delahunt 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.
PubMed 29886432Nguyen 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.
PubMed 33634747