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Ankle Injuries and DisordersNCT04699396

The Immediate Effect of Mobilisation With Movement in Amateur Futsal Athletes With Chronic Ankle Instability

A study testing Mobilisation With Movement 1 and Mobilisation With Movement 2 in people with Ankle Injuries and Disorders, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Chronic ankle instability (CAI) is an increasingly prevalent condition among futsal athletes. Mobilization with Movement (MWM) is a conservative rehabilitation strategy commonly used in this condition. Even so, the effects of two MWM dorsiflexion techniques on sports performance are not known. Read more about this study

Who is it for?
Ages 18 to 35 years, men only
Conditions the study is for
Ankle Injuries and Disorders
What is being tested?
Mobilisation With Movement 1 and Mobilisation With Movement 2
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
18 participants
Where
1 sitePortugal
Study dates
14 Jan 2021to 28 Feb 2021
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 35 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • A history of at least one significative ankle sprain:
  • Initial sprain must have occurred at least 12 months prior to study enrolment;
  • Was associated with inflammatory symptoms;
  • Created at least one interrupted day of desired physical activity;
  • The most recent injury must have occurred more than 3 months prior to study enrolment.
  • A history of the previously injured ankle joint "giving way" and/or recurrent sprain and/or "feelings of instability":
Show all 9Show fewer
  • Participants should report at least two episodes of "giving way" in the 12 months prior to study enrolment, to account for the seasonal nature of futsal;
  • Recurrent sprain was defined as two or more sprains to the same ankle.
  • Self-reported ankle instability should be confirmed with the Ankle Instability Instrument: answer "yes" to at least 5 yes/no questions.

Who cannot join

  • A history of previous surgeries to the musculoskeletal structures (i.e., bones, joint structures, nerves) in either lower extremity.
  • A history of bilateral ankle sprain.
  • A history of a fracture in either lower extremity requiring realignment.
  • Acute injury to musculoskeletal structures of other joints of the lower extremity in the previous 3 months that impacted joint integrity and function (i.e., sprains, fractures), resulting in at least one interrupted day of desired physical activity.
  • Have conditions for which manual therapy is generally contraindicated (such as the presence of a tumour, fracture, rheumatoid arthritis, osteoporosis, prolonged history of steroid use, or severe vascular disease).
  • Receiving concurrent physiotherapy treatment in the last 3 months.
  • Inability to read Portuguese.

Trial locations and contacts

1 site in 1 country.

Portugal1 site

  • Escola Superior de Saúde do Porto

    Porto, 4200-072

Other trials in Portugal

About this study

Official title: The Immediate Effect of Two Mobilization With Movement Techniques on Dorsiflexion, Dynamic Balance and Performance Variables, in Futsal Athletes With Chronic Ankle Instability: A Randomized Controlled Trial

Chronic ankle instability (CAI) is an increasingly prevalent condition among futsal athletes. Mobilization with Movement (MWM) is a conservative rehabilitation strategy commonly used in this condition. Even so, the effects of two MWM dorsiflexion techniques on sports performance are not known. The aim is to analyze the immediate effect of two MWM techniques on the dorsiflexion range of motion, the dynamic balance and the performance variables in futsal athletes with CAI. Also, to analyze the impact of performing them in a different order.

Being tested
Mobilisation With Movement 1, Mobilisation With Movement 2, Placebo
Medical subject headings
Ankle Injuries, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mobilisation With Movement 1Procedure or surgery

    Also called Mulligan

    Application of a sustained passive accessory movement to a joint (talus or fibula) while the patient actively performs a forward lean/lunge that was previously limited.

    3 sets of 10 repetitions of a glide applied to the talus were performed, followed by 3 sets of 10 repetitions of a glide applied to the fibula.

  • Mobilisation With Movement 2Procedure or surgery

    Also called Mulligan

    Application of a sustained passive accessory movement to a joint (talus or fibula) while the patient actively performs a forward lean/lunge that was previously limited.

    3 sets of 10 repetitions of a glide applied to the fibula were performed, followed by 3 sets of 10 repetitions of a glide applied to the talus.

  • PlaceboOther

    The Placebo group participants performed the same number of sets and repetitions (6 sets of 20 repetitions) of lean/lunge forward into dorsiflexion, without any glide application.

Study groups in NCT04699396
Study groupRoleWhat they receive
Mobilisation with Movement 1 (MWM1)ExperimentalParticipants received two ankle dorsiflexion MWM techniques, with glides applied at fibula and talus. Three sets of 10 repetitions of each techniques, were administrated.
Receives: Procedure: Mobilisation With Movement 1
Mobilisation with Movement 2 (MWM2)ExperimentalParticipants received two ankle dorsiflexion MWM techniques, with glides applied at talus and fibula (order of application inverted). Three sets of 10 repetitions of each techniques, were administrated.
Receives: Procedure: Mobilisation With Movement 2
PlaceboPlacebo comparatorThe Placebo group participants performed the same number of sets and repetitions of lean/lunge forward into dorsiflexion, without any glide application, in the same position
Receives: Other: Placebo
InterventionExperimentalThe experimental groups (MWM1 and MWM2), were later merged into a single Intervention group.
Receives: Procedure: Mobilisation With Movement 1; Procedure: Mobilisation With Movement 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dorsiflexion range of motion

    The dorsiflexion range of motion (DFROM) of the ankle joint was measured by the Weight-Bearing Lunge Test (WBLT)

    Measured: Immediate after procedure

Secondary outcomes (2)

  1. Dynamic balance

    The dynamic balance was measured by the anterior (ANT), posteromedial (PM) and posterolateral (PL) reach directions of the Star Excursion Balance Test (SEBT)

    Measured: Immediate after procedure

  2. Performance variables

    The performance variables were measured by the time needed to complete the Side Hop Test and the Sprint Test

    Measured: Immediate after procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2021
  2. Study start14 Jan 2021
  3. Primary completion28 Feb 2021
  4. Study completion28 Feb 2021

Resources

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
Participant
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04699396
Sponsor's protocol ID
ESS-MWM
Status last verified
Mar 2021
First submitted
30 Dec 2020
Last updated
9 Mar 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Lopez-Segovia M, Vivo Fernandez I, Herrero Carrasco R, Pareja Blanco F. Preseason Injury Characteristics in Spanish Professional Futsal Players: The LNFS Project. J Strength Cond Res. 2022 Jan 1;36(1):232-237. doi: 10.1519/JSC.0000000000003419.

    PubMed 31895285

  • Hertel J, Corbett RO. An Updated Model of Chronic Ankle Instability. J Athl Train. 2019 Jun;54(6):572-588. doi: 10.4085/1062-6050-344-18. Epub 2019 Jun 4.

    PubMed 31162943

  • Cruz-Diaz D, Lomas Vega R, Osuna-Perez MC, Hita-Contreras F, Martinez-Amat A. Effects of joint mobilization on chronic ankle instability: a randomized controlled trial. Disabil Rehabil. 2015;37(7):601-10. doi: 10.3109/09638288.2014.935877. Epub 2014 Jul 3.

    PubMed 24989067

  • Langarika-Rocafort A, Emparanza JI, Aramendi JF, Castellano J, Calleja-Gonzalez J. Intra-rater reliability and agreement of various methods of measurement to assess dorsiflexion in the Weight Bearing Dorsiflexion Lunge Test (WBLT) among female athletes. Phys Ther Sport. 2017 Jan;23:37-44. doi: 10.1016/j.ptsp.2016.06.010. Epub 2016 Jun 29.

    PubMed 27665249

  • Marron-Gomez D, Rodriguez-Fernandez AL, Martin-Urrialde JA. The effect of two mobilization techniques on dorsiflexion in people with chronic ankle instability. Phys Ther Sport. 2015 Feb;16(1):10-5. doi: 10.1016/j.ptsp.2014.02.001. Epub 2014 Feb 14.

    PubMed 24679362

  • Gribble PA, Delahunt E, Bleakley C, Caulfield B, Docherty CL, Fourchet F, Fong D, Hertel J, Hiller C, Kaminski TW, McKeon PO, Refshauge KM, van der Wees P, Vicenzino B, Wikstrom EA. Selection criteria for patients with chronic ankle instability in controlled research: a position statement of the International Ankle Consortium. J Orthop Sports Phys Ther. 2013 Aug;43(8):585-91. doi: 10.2519/jospt.2013.0303. Epub 2013 Jul 31.

    PubMed 23902805

Questions about this trial

What is this clinical trial studying?

A study testing Mobilisation With Movement 1 and Mobilisation With Movement 2 in people with Ankle Injuries and Disorders, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.

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 9 inclusion and 7 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 9 Mar 2021. 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 Portugal. 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?

Dorsiflexion range of motion (time frame: Immediate after procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04699396, which also lists 6 linked publications.

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 9 Mar 2021.

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