- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05250739
Neuromuscular Training vs Strength Training
Effect of Neuromuscular Training vs Strength Training in Chronic Ankle Instability
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Jaen, Spain, 23071
- University of Jaén
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Strength training
Participants completed 16 training sessions of strength training during eight weeks.
|
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.
|
|
Experimental: Neuromuscular training
Participants completed 16 training sessions of neuromuscular training during eight weeks.
|
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.
|
|
No Intervention: Control group
The Control group received no intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-reported instability
Time Frame: From baseline to eight weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ankle range of motion
Time Frame: From baseline to eight weeks
|
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
|
|
Dynamic balance
Time Frame: From baseline to eight weeks
|
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
|
|
Functional status
Time Frame: From baseline to eight weeks
|
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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ANKLEST
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.