Ankle Sprain 1St DegreeNCT03948503
Mulligan Concept in the Treatment of Ankle Sprains
A study testing Mulligan concept in people with Ankle Sprain 1St Degree and Ankle Sprain 2Nd Degree, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Aim of the study is to establish the efficiency of the mulligan concept vs a sham group (who will also serve as control). Patient with an subacute ankle sprains will be assess following the mulligan concept and then randomized in two groups: Mobilization with movement (MWM) group and Sham group. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Ankle Sprain 1St Degree, Ankle Sprain 2Nd Degree
- What is being tested?
- Mulligan concept
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2019to 30 Oct 2019
- 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 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ankle sprain since 2 weeks to 12 weeks
- Grade 1 or 2 ankle sprain
- Asymetrical dorsi-flexion limitation
Who cannot join
- Acute or Grade 3 ankle sprain
- More than 12 weeks ankle sprain
- Any other trauma of the lower limb
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mulligan Concept in the Treatment of Subacute Ankle Sprains: a Randomized Placebo Trial.
Aim of the study is to establish the efficiency of the mulligan concept vs a sham group (who will also serve as control). Patient with an subacute ankle sprains will be assess following the mulligan concept and then randomized in two groups: Mobilization with movement (MWM) group and Sham group. MWM group will receive 3 sets of 10 repetitions of treatment (i.e. passive accessory glide during an active dorsiflexion) while the sham treatment will do 3 sets of 10 active dorsiflexion with the hand of the Physiotherapist only apply on the skin. 3 sessions with 4 days apart will take place. outcomes will be measure before and after every sessions.
Read the detailed description
All included subject will received the Mulligan concept assessment. First investigator will applied non-weight bearing inferior tibiofibular mobilization with movement (MWM), i.e. passive accessory glide in a posterior and superior direction on the inferior tibiofibular joint. If not painful, Weightbearing inferior tibiofibular MWM will be applied 6 times. it consist on applying a passive accessory glide on the subject while he/she is doing an active dorsiflexion of the injured ankle. Dorsiflexion range of motion, pain and function will be reassess. If either one of previously cited outcomes is improve, subject is considered respondents. If he/she feels any pain or no improvements at all, he/she will be considered non-respondents. If non-weight-bearing inferior tibiofibular MWM is painful, talocrural MWM will be apply, first in non-weightbearing and if painfree, in weight bearing position. Talocrural MWM consist on a posterior glide of the talus while the subject realized an active dorsiflexion of the injured ankle. Same outcomes as previsouly cited will be assess and will determine if the patient is respondent or non-respondent. If the subject is non-respondent of the talocrural MWM or if he/she felt any pain during the talocrural MWM, a non weightbearing cubometatarsal MWM, i.e. cranio-caudal glide of the lateral cubometatarsal joint during an active dorsiflexion of the injured ankle, will be applied. If painfree, a tape will be placed as to replicate the cubometatarsal MWM, and the patient will reassess ROM, pain and function with the tape to see whether he/she is a respondent or non respondent subject. If the subject is non-respondent to neither of the three MWM, he/she is considered a drop-out. Respondent patient will then be randomized into two groups: MWM group and Sham group. MWM group will receive 3 sessions with 4 days apart of 3 sets of 10 repetitions of preferential MWM (inferior tibiofibular, talocrural, cubometatarsal) while the sham group will receive 3 sessions with 4 days apart of 3 sets of 10 repetitions with the first investigator doing a light touch during an active dorsiflexion, mimicking the real MWM techniques. Outcomes will be measures at T0 (beginning of the treatment-beginning of the first session), T1 (end of the first session), T2 (beginning of the second session), T3 (end of the second session), T4 (beginning of the third session) and T5 (end of the treatment-end of the third session).
- Conditions
- Ankle Sprain 1St Degree, Ankle Sprain 2Nd Degree
- Being tested
- Mulligan concept, Placebo
- Keywords
- ankle sprain, Mulligan, manual therapy
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mulligan conceptProcedure or surgery
Mobilization with movement during an active dorsi-flexion of the ankle
PlaceboProcedure or surgery
Sham mobilization with movement during an active dorsi-flexion of the ankle
| Study group | Role | What they receive |
|---|---|---|
| Mobilization with movement (MWM) group | Experimental | Application of the Mulligan concept Receives: Procedure: Mulligan concept |
| Sham group | Placebo comparator | Sham treatment Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ankle dorsiflexion Range of motion
Wall toe test (distance in cm and degree in °)
Measured: At the beginning (Time1) and end (Time2) of each session (one session is 30 minutes). Every session is separated by 4 days. Outcomes is taken at Day 1(session1) at Time1 & Time2 ,Day 5(session2) at Time1 & Time2 and Day 9(session3) at Time1 & Time2 .
Secondary outcomes (5)
Change in Pain
a 10cm Visual Analog Scale
Measured: At the beginning (Time1) and end (Time2) of each session (one session is 30 minutes). Every session is separated by 4 days. Outcomes is taken at Day 1(session1) at Time1 & Time2 ,Day 5(session2) at Time1 & Time2 and Day 9(session3) at Time1 & Time2 .
Change in Stiffness sensation
Visual Analog Scale (VAS)
Measured: At the beginning (Time1) and end (Time2) of each session (one session is 30 minutes). Every session is separated by 4 days. Outcomes is taken at Day 1(session1) at Time1 & Time2 ,Day 5(session2) at Time1 & Time2 and Day 9(session3) at Time1 & Time2 .
Change in Dynamic function
Y-test
Measured: At the beginning (Time1) and end (Time2) of each session (one session is 30 minutes). Every session is separated by 4 days. Outcomes is taken at Day 1(session1) at Time1 & Time2 ,Day 5(session2) at Time1 & Time2 and Day 9(session3) at Time1 & Time2 .
Change in fonctionnel movement
Forward step down test
Measured: At the beginning (Time1) of Day1 (Session1) and end of Day9 (Session3). One session is 30 minutes long. Each session is separated by 4 days.
Change inDaily-life function
Foot and Ankle Ability Measure (FAAM) questionnaire
Measured: At the beginning (Time1) of Day1 (Session1) and end (Time2) of Day9 (Session3). One session is 30 minutes long. Each session is separated by 4 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start1 Jun 2019
- Primary completion31 Jul 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle Sprain 1St DegreeStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Mahaudens, Principal investigator, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948503
- Sponsor's protocol ID
- 2018/21NOV/439
- Status last verified
- Jun 2022
- First submitted
- 19 Mar 2019
- Last updated
- 24 Jun 2022
- 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 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mulligan Concept in the Treatment of Subacute Ankle Sprains: a Randomized Placebo Trial.
- ClinicalTrials.gov ID
- NCT03948503
- Acronym / sponsor ID
- 2018/21NOV/439
- Conditions
- Ankle Sprain 1St Degree, Ankle Sprain 2Nd Degree
- Keywords
- ankle sprain, Mulligan, manual therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 14 May 2019 (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.
Aim of the study is to establish the efficiency of the mulligan concept vs a sham group (who will also serve as control). Patient with an subacute ankle sprains will be assess following the mulligan concept and then randomized in two groups: Mobilization with movement (MWM) group and Sham group. MWM group will receive 3 sets of 10 repetitions of treatment (i.e. passive accessory glide during an active dorsiflexion) while the sham treatment will do 3 sets of 10 active dorsiflexion with the hand of the Physiotherapist only apply on the skin. 3 sessions with 4 days apart will take place. outcomes will be measure before and after every sessions.
Detailed description
All included subject will received the Mulligan concept assessment. First investigator will applied non-weight bearing inferior tibiofibular mobilization with movement (MWM), i.e. passive accessory glide in a posterior and superior direction on the inferior tibiofibular joint. If not painful, Weightbearing inferior tibiofibular MWM will be applied 6 times. it consist on applying a passive accessory glide on the subject while he/she is doing an active dorsiflexion of the injured ankle. Dorsiflexion range of motion, pain and function will be reassess. If either one of previously cited outcomes is improve, subject is considered respondents. If he/she feels any pain or no improvements at all, he/she will be considered non-respondents. If non-weight-bearing inferior tibiofibular MWM is painful, talocrural MWM will be apply, first in non-weightbearing and if painfree, in weight bearing position. Talocrural MWM consist on a posterior glide of the talus while the subject realized an active dorsiflexion of the injured ankle. Same outcomes as previsouly cited will be assess and will determine if the patient is respondent or non-respondent. If the subject is non-respondent of the talocrural MWM or if he/she felt any pain during the talocrural MWM, a non weightbearing cubometatarsal MWM, i.e. cranio-caudal glide of the lateral cubometatarsal joint during an active dorsiflexion of the injured ankle, will be applied. If painfree, a tape will be placed as to replicate the cubometatarsal MWM, and the patient will reassess ROM, pain and function with the tape to see whether he/she is a respondent or non respondent subject. If the subject is non-respondent to neither of the three MWM, he/she is considered a drop-out. Respondent patient will then be randomized into two groups: MWM group and Sham group. MWM group will receive 3 sessions with 4 days apart of 3 sets of 10 repetitions of preferential MWM (inferior tibiofibular, talocrural, cubometatarsal) while the sham group will receive 3 sessions with 4 days apart of 3 sets of 10 repetitions with the first investigator doing a light touch during an active dorsiflexion, mimicking the real MWM techniques. Outcomes will be measures at T0 (beginning of the treatment-beginning of the first session), T1 (end of the first session), T2 (beginning of the second session), T3 (end of the second session), T4 (beginning of the third session) and T5 (end of the treatment-end of the third session).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobilization with movement (MWM) group | Experimental | Procedure: Mulligan conceptApplication of the Mulligan concept |
| Sham group | Placebo comparator | Procedure: PlaceboSham treatment |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ankle sprain since 2 weeks to 12 weeks
- Grade 1 or 2 ankle sprain
- Asymetrical dorsi-flexion limitation
Key exclusion criteria (3 listed)
- Acute or Grade 3 ankle sprain
- More than 12 weeks ankle sprain
- Any other trauma of the lower limb
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 |
|---|---|---|
| Mulligan conceptMobilization with movement during an active dorsi-flexion of the ankle | Procedure or surgery | Mobilization with movement (MWM) group |
| PlaceboSham mobilization with movement during an active dorsi-flexion of the ankle | Procedure or surgery | Sham group |
Primary outcome
Change in Ankle dorsiflexion Range of motion
Time frame: At the beginning (Time1) and end (Time2) of each session (one session is 30 minutes). Every session is separated by 4 days. Outcomes is taken at Day 1(session1) at Time1 & Time2 ,Day 5(session2) at Time1 & Time2 and Day 9(session3) at Time1 & Time2 .
Wall toe test (distance in cm and degree in °)
5 secondary outcomes
Change in Pain
Time frame: At the beginning (Time1) and end (Time2) of each session (one session is 30 minutes). Every session is separated by 4 days. Outcomes is taken at Day 1(session1) at Time1 & Time2 ,Day 5(session2) at Time1 & Time2 and Day 9(session3) at Time1 & Time2 .
Change in Stiffness sensation
Time frame: At the beginning (Time1) and end (Time2) of each session (one session is 30 minutes). Every session is separated by 4 days. Outcomes is taken at Day 1(session1) at Time1 & Time2 ,Day 5(session2) at Time1 & Time2 and Day 9(session3) at Time1 & Time2 .
Change in Dynamic function
Time frame: At the beginning (Time1) and end (Time2) of each session (one session is 30 minutes). Every session is separated by 4 days. Outcomes is taken at Day 1(session1) at Time1 & Time2 ,Day 5(session2) at Time1 & Time2 and Day 9(session3) at Time1 & Time2 .
Change in fonctionnel movement
Time frame: At the beginning (Time1) of Day1 (Session1) and end of Day9 (Session3). One session is 30 minutes long. Each session is separated by 4 days.
Change inDaily-life function
Time frame: At the beginning (Time1) of Day1 (Session1) and end (Time2) of Day9 (Session3). One session is 30 minutes long. Each session is separated by 4 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
- Individual participant dataSharing planned: No
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.
Philippe Mahaudens principal investigator
Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mulligan concept in people with Ankle Sprain 1St Degree and Ankle Sprain 2Nd Degree, run by Université Catholique de Louvain at 1 site in Belgium.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 24 Jun 2022. 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 Belgium. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Ankle dorsiflexion Range of motion (time frame: At the beginning (Time1) and end (Time2) of each session (one session is 30 minutes). Every session is separated by 4 days. Outcomes is taken at Day 1(session1) at Time1 & Time2 ,Day 5(session2) at Time1 & Time2 and Day 9(session3) at Time1 & Time2 .). 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 24 Jun 2022.