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Neuromuscular Training vs Strength Training

Primary Purpose

Ankle Injuries

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Strength training
Neuromuscular training
Sponsored by
DAVID CRUZ DÍAZ
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Injuries

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Jaen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Strength training

Neuromuscular training

Control group

Arm Description

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

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

The Control group received no intervention.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
February 10, 2022
Last Updated
February 22, 2022
Sponsor
DAVID CRUZ DÍAZ
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1. Study Identification

Unique Protocol Identification Number
NCT05250739
Brief Title
Neuromuscular Training vs Strength Training
Official Title
Effect of Neuromuscular Training vs Strength Training in Chronic Ankle Instability
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
November 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
DAVID CRUZ DÍAZ

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A single-blind randomized controlled trial.
Masking
InvestigatorOutcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Strength training
Arm Type
Experimental
Arm Description
Participants completed 16 training sessions of strength training during eight weeks.
Arm Title
Neuromuscular training
Arm Type
Experimental
Arm Description
Participants completed 16 training sessions of neuromuscular training during eight weeks.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The Control group received no intervention.
Intervention Type
Other
Intervention Name(s)
Strength training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Neuromuscular training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-reported instability
Description
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)
Time Frame
From baseline to eight weeks
Secondary Outcome Measure Information:
Title
Ankle range of motion
Description
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.
Time Frame
From baseline to eight weeks
Title
Dynamic balance
Description
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.
Time Frame
From baseline to eight weeks
Title
Functional status
Description
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.
Time Frame
From baseline to eight weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Cruz-Diaz, PhD
Organizational Affiliation
University of Jaen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Jaen
City
Jaen
ZIP/Postal Code
23071
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Not allowed due to personal data legal protection issues.
Citations:
PubMed Identifier
33362991
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.
Results Reference
background
PubMed Identifier
16009979
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. doi: 10.1177/0363546505275490. Epub 2005 Jul 11.
Results Reference
background
PubMed Identifier
34589684
Citation
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.
Results Reference
background

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