NCT05250739

Brief Summary

Chronic ankle instability is a complex condition. Limited mobility, perceived instability, and recurrent ankle sprains are common characteristics that reduce the quality of life in subjects who suffer chronic ankle instability. Neuromuscular training and strength training has been recommended in chronic ankle instability management interventions. However, there are contradictory findings on results when comparing neuromuscular training, strength training, and control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

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

Study Start

First participant enrolled

March 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 22, 2022

Completed
Last Updated

March 10, 2022

Status Verified

February 1, 2022

Enrollment Period

7 months

First QC Date

February 10, 2022

Last Update Submit

February 22, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Self-reported instability

    To determine the presence and severity of chronic ankle instability, participants completed the Cumberland Ankle Instability Tool, a valid and reliable instrument for measuring the severity of ankle instability. The Cumberland Ankle Instability Tool is a 9-item subjective questionnaire with a range score from 0 (severe instability) to 30 (normal stability)

    From baseline to eight weeks

Secondary Outcomes (3)

  • Ankle range of motion

    From baseline to eight weeks

  • Dynamic balance

    From baseline to eight weeks

  • Functional status

    From baseline to eight weeks

Study Arms (3)

Strength training

EXPERIMENTAL

Participants completed 16 training sessions of strength training during eight weeks.

Other: Strength training

Neuromuscular training

EXPERIMENTAL

Participants completed 16 training sessions of neuromuscular training during eight weeks.

Other: Neuromuscular training

Control group

NO INTERVENTION

The Control group received no intervention.

Interventions

Strength training was performed with resistance bands. The band was fastened to the unaffected ankle, while the participant was told to perform front and back pulls, as well as adduction and abduction movements with the affected ankle. They were told to control the ankle movement and to make it slow. Since the first day, they were told to perform the exercise pulling the band as if they wanted to make the resistance of 5 on a scale from 0 to 10.

Strength training

consisted in a multi-station training with 6 exercises, increasing the difficulty progressively as the participants controlled the execution. The exercises were all performed barefoot and with the injured foot. These were a combination of standing and jumping exercises involving the injured ankle. The participants did not start the next progression until they perform a complete circuit in the level before.

Neuromuscular training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To have suffered the first sprain at least 6 months before the beginning of the study.
  • Cumberland ankle instability score ≤24.
  • To be physically active.

You may not qualify if:

  • Participants could not have suffered an acute sprain in the 6 previous weeks to the beginning of the study.
  • History of recent ankle surgery.
  • Epilepsy or previous seizures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Jaen

Jaén, 23071, Spain

Location

Related Publications (3)

  • Halabchi F, Hassabi M. Acute ankle sprain in athletes: Clinical aspects and algorithmic approach. World J Orthop. 2020 Dec 18;11(12):534-558. doi: 10.5312/wjo.v11.i12.534. eCollection 2020 Dec 18.

    PMID: 33362991BACKGROUND
  • Beynnon BD, Vacek PM, Murphy D, Alosa D, Paller D. First-time inversion ankle ligament trauma: the effects of sex, level of competition, and sport on the incidence of injury. Am J Sports Med. 2005 Oct;33(10):1485-91. doi: 10.1177/0363546505275490. Epub 2005 Jul 11.

    PMID: 16009979BACKGROUND
  • Ahern L, Nicholson O, O'Sullivan D, McVeigh JG. Effect of Functional Rehabilitation on Performance of the Star Excursion Balance Test Among Recreational Athletes With Chronic Ankle Instability: A Systematic Review. Arch Rehabil Res Clin Transl. 2021 May 21;3(3):100133. doi: 10.1016/j.arrct.2021.100133. eCollection 2021 Sep.

    PMID: 34589684BACKGROUND

MeSH Terms

Conditions

Ankle Injuries

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • David Cruz-Diaz, PhD

    University of Jaen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
An independent assessor blinded to the data collection was responsible for the allocation process. A list of the computer-generated number was employed to assign participants to experimental or control group
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A single-blind randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 10, 2022

First Posted

February 22, 2022

Study Start

March 1, 2021

Primary Completion

October 1, 2021

Study Completion

November 10, 2021

Last Updated

March 10, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Not allowed due to personal data legal protection issues.

Locations