NCT03948503

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 14, 2019

Completed
18 days until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
Last Updated

June 24, 2022

Status Verified

June 1, 2022

Enrollment Period

2 months

First QC Date

March 19, 2019

Last Update Submit

June 23, 2022

Conditions

Ankle Sprain 1St DegreeAnkle Sprain 2Nd Degree

Keywords

ankle sprainMulliganmanual therapy

Outcome Measures

Primary Outcomes (1)

  • Change in Ankle dorsiflexion Range of motion

    Wall toe test (distance in cm and degree in °)

    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

    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

    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

    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

    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

    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.

Study Arms (2)

Mobilization with movement (MWM) group

EXPERIMENTAL

Application of the Mulligan concept

Procedure: Mulligan concept

Sham group

PLACEBO COMPARATOR

Sham treatment

Procedure: Placebo

Interventions

Mulligan conceptPROCEDURE

Mobilization with movement during an active dorsi-flexion of the ankle

Mobilization with movement (MWM) group
PlaceboPROCEDURE

Sham mobilization with movement during an active dorsi-flexion of the ankle

Sham group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ankle sprain since 2 weeks to 12 weeks
  • Grade 1 or 2 ankle sprain
  • Asymetrical dorsi-flexion limitation

You may not qualify if:

  • Acute or Grade 3 ankle sprain
  • More than 12 weeks ankle sprain
  • Any other trauma of the lower limb

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Philippe Mahaudens

    Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2019

First Posted

May 14, 2019

Study Start

June 1, 2019

Primary Completion

July 31, 2019

Study Completion

October 30, 2019

Last Updated

June 24, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)