Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03948503 |
| Other study ID # |
2018/21NOV/439 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2019 |
| Est. completion date |
October 30, 2019 |
Study information
| Verified date |
June 2022 |
| Source |
Université Catholique de Louvain |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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).
