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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05250739
Other study ID # ANKLEST
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date November 10, 2021

Study information

Verified date February 2022
Source University of Jaén
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Participants were randomly assigned to the neuromuscular training group, strength training group, and control group with no intervention if participants met the inclusion criteria. Neuromuscular training group. It consisted of 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. A strength training group 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. Participants were told to control the ankle movement and to make it slow. Control group received no intervention.


Recruitment information / eligibility

Status Completed
Enrollment 67
Est. completion date November 10, 2021
Est. primary completion date October 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion criteria were consistent with recommendations made from International Ankle Consortium16 and were checked before the intervention: - 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. Exclusion criteria. - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Strength training
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.
Neuromuscular 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.

Locations

Country Name City State
Spain University of Jaen Jaen

Sponsors (1)

Lead Sponsor Collaborator
DAVID CRUZ DÍAZ

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. Review. — View Citation

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. Epub 2005 Jul 11. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Ankle range of motion Ankle dorsiflexion range of motion was assessed by the weight-bearing lunge test. The patient is positioned in a standing position facing a wall with the involved foot parallel with a tape measure which has been attached to the floor and the opposite leg placed behind in a tandem stance. A forward lunge is performed until the anterior knee tries to make contact with the wall with the heel firmly planted on the ground. From baseline to eight weeks
Secondary Dynamic balance Dynamic balance has been measured by a simplified version of the Star Excursion Balance Test where the anterior, posteromedial and posterolateral reach directions were collected for statistical analysis. From baseline to eight weeks
Secondary Functional status Function in daily living and sport activities were assessed by the Foot and Ankle Ability Measure. This questionnaire Is divided by two subscales of 21 items (daily living subscale) and 8 items (sports subscale). The obtained score is expressed as a percentage calculated by dividing the patient's score by max score and the lower percentage is related to the lower level of function. From baseline to eight weeks
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