Mulligan Concept in the Treatment of Ankle Sprains
Primary Purpose
Ankle Sprain 1St Degree, Ankle Sprain 2Nd Degree
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Mulligan concept
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Ankle Sprain 1St Degree focused on measuring ankle sprain, Mulligan, manual therapy
Eligibility Criteria
Inclusion Criteria:
- ankle sprain since 2 weeks to 12 weeks
- Grade 1 or 2 ankle sprain
- Asymetrical dorsi-flexion limitation
Exclusion Criteria:
- Acute or Grade 3 ankle sprain
- More than 12 weeks ankle sprain
- Any other trauma of the lower limb
Sites / Locations
- Cliniques universitaires Saint-Luc
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Mobilization with movement (MWM) group
Sham group
Arm Description
Application of the Mulligan concept
Sham treatment
Outcomes
Primary Outcome Measures
Change in Ankle dorsiflexion Range of motion
Wall toe test (distance in cm and degree in °)
Secondary Outcome Measures
Change in Pain
a 10cm Visual Analog Scale
Change in Stiffness sensation
Visual Analog Scale (VAS)
Change in Dynamic function
Y-test
Change in fonctionnel movement
Forward step down test
Change inDaily-life function
Foot and Ankle Ability Measure (FAAM) questionnaire
Full Information
NCT ID
NCT03948503
First Posted
March 19, 2019
Last Updated
June 23, 2022
Sponsor
Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT03948503
Brief Title
Mulligan Concept in the Treatment of Ankle Sprains
Official Title
Mulligan Concept in the Treatment of Subacute Ankle Sprains: a Randomized Placebo Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
October 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université Catholique de Louvain
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprain 1St Degree, Ankle Sprain 2Nd Degree
Keywords
ankle sprain, Mulligan, manual therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mobilization with movement (MWM) group
Arm Type
Experimental
Arm Description
Application of the Mulligan concept
Arm Title
Sham group
Arm Type
Placebo Comparator
Arm Description
Sham treatment
Intervention Type
Procedure
Intervention Name(s)
Mulligan concept
Intervention Description
Mobilization with movement during an active dorsi-flexion of the ankle
Intervention Type
Procedure
Intervention Name(s)
Placebo
Intervention Description
Sham mobilization with movement during an active dorsi-flexion of the ankle
Primary Outcome Measure Information:
Title
Change in Ankle dorsiflexion Range of motion
Description
Wall toe test (distance in cm and degree in °)
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 .
Secondary Outcome Measure Information:
Title
Change in Pain
Description
a 10cm Visual Analog Scale
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 .
Title
Change in Stiffness sensation
Description
Visual Analog Scale (VAS)
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 .
Title
Change in Dynamic function
Description
Y-test
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 .
Title
Change in fonctionnel movement
Description
Forward step down test
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.
Title
Change inDaily-life function
Description
Foot and Ankle Ability Measure (FAAM) questionnaire
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ankle sprain since 2 weeks to 12 weeks
Grade 1 or 2 ankle sprain
Asymetrical dorsi-flexion limitation
Exclusion Criteria:
Acute or Grade 3 ankle sprain
More than 12 weeks ankle sprain
Any other trauma of the lower limb
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Mahaudens
Organizational Affiliation
Université Catholique de Louvain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
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Mulligan Concept in the Treatment of Ankle Sprains
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