Ankle SprainsNCT01853462
Effects of Two Supervised Training Programs for the Rehabilitation of Ankle Sprains
A study testing PNF training and Balance training in people with Ankle Sprains, run by Lazaros Lazarou at 1 site in Greece.
Trial summary
The purpose of this study was to determine the effects of supervised balance and proprioceptive neuromuscular facilitation (PNF) training for the rehabilitation of ankle sprains Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Ankle Sprains
- What is being tested?
- PNF training and Balance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteGreece
- Study dates
- Dec 2014to Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals with a symptomatic, conventionally treated, post acute (after 14 days) lateral ankle sprain, Grade I-II
Who cannot join
- Individuals with lateral ankle sprains Grade III
- Individuals with ankle sprain to the medial ligaments
- Individuals with ankle sprain to the interosseous (syndesmotic) ligament
- Individuals with concurrent fracture
- Individuals with chronic ankle instability
- Individuals with history of surgery to the ankles
Show all 9Show fewer
- Individuals with history of lower limb nerve injuries
- Individuals with history of further ankle injuries, after the sprain
- Individuals with any injuries that hindered training participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Supervised Balance and Proprioceptive Neuromuscular Facilitation Training After Lateral Ligament Sprains of the Ankle
The purpose of this study was to determine the effects of supervised balance and proprioceptive neuromuscular facilitation (PNF) training for the rehabilitation of ankle sprains
Read the detailed description
Supervised proprioceptive training has been recommended by recently published guidelines for the rehabilitation of ankle sprains. However, research evidence on the efficacy of this type of training is still weak, mainly owing to the methodological limitations of relevant studies. In addition, there is paucity of evidence concerning the effects of such training for the outcomes of functional performance, pain, ankle range of motion, and contradictory results have been reported for postural control.
This study aimed to substantiate the benefits of supervised training for the rehabilitation of ankle sprains, and elucidate the effects of two different proprioceptive protocols on the above-mentioned outcomes.
- Conditions
- Ankle Sprains
- Being tested
- PNF training, Balance training
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNF trainingOther
Ten individual PNF sessions, supervised by a physical therapist, with 50-60 min duration per session, within a maximal five-week period
Balance trainingOther
Ten individual balance sessions, supervised by a physical therapist, with 50-60 min duration per session, within a maximal five-week period
| Study group | Role | What they receive |
|---|---|---|
| Proprioceptive Neuromuscular Facilitation (PNF) | Experimental | Supervised PNF training Receives: Other: PNF training |
| Balance | Experimental | Supervised balance training Receives: Other: Balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle Functional Stability, Via the Single-leg Hop for Distance Test
Participants hopped, using the sprained leg, as far forward as possible, and remained in the landing position for 2sec. Three trials were performed, and the mean hopping distance was used for analysis.
Measured: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Ankle Functional Stability, Via the Single-leg Hops for Time Test
Participants hopped, using the sprained leg, as fast as possible, a six-meter distance. Three trials were performed, and the mean hopping time was used for analysis.
Measured: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Endurance of Ankle Dorsiflexor Muscles
The rising on heel test was used, and participants rose on the heel of the sprained leg, as many times as possible.
Scoring:10 points for >40 rises, 5 points for 30-39 rises, 0 points for <30 rises.
Measured: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Endurance of Ankle Plantar Flexor Muscles
The rising on toes test was used, and participants rose on the toes of the sprained leg, as many times as possible. Scoring:10 points for >40 rises, 5 points for 30-39 rises, 0 points for <30 rises.
Measured: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Secondary outcomes (27)
Anterior-posterior Stability Index
The Biodex Stability System, which is a dynamic tilting platform, was used for assessment. The anterior-posterior stability index corresponded to the variance of foot platform displacement in the sagittal plane, and it was measured in single-leg stance, for the sprained leg, without footwear. Three 20-sec trials were performed, with open eyes, and the mean score was used for analysis.
Measured: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Medial-lateral Stability Index
The Biodex Stability System, which is a dynamic tilting platform, was used for assessment. The medial-lateral stability index corresponded to the variance of foot platform displacement in the frontal plane, and it was measured in single-leg stance, for the sprained leg, without footwear. Three 20-sec trials were performed, with open eyes, and the mean score was used for analysis.
Measured: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Overall Stability Index
The Biodex Stability System, which is a dynamic tilting platform, was used for assessment. The overall stability index corresponded to the variance of foot platform overall displacement, and it was measured in single-leg stance, for the sprained leg, without footwear. Three 20-sec trials were performed, with open eyes, and the mean score was used for analysis.
Measured: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Ankle Dorsiflexion Range of Motion
Assessement was performed with a goniometer. Participants actively dorsiflexed the sprained ankle, while being in long sitting, on a physical therapy table. The mean score of three measurements was used for analysis.
Measured: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Pain Sensation
The main component of the Greek version of the short form of McGill Pain Questionnaire (GR-SFMPQ) was used for the assessment of pain sensation of the sprained ankle. This consists of 15 descriptive adjectives for the pain sensation (11 sensory and 4 affective), which are self-rated according to their intensity level on a 4-point rating scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). The total rating score (minimum = 0, maximum = 45) of the main component of the GR-SFMPQ was used for data analysis, with higher values representing a worse pain sensation.
Measured: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Pain Intensity During the Week Before Testing
The second component of the Greek version of the short form of McGill Pain Questionnaire, which is a visual analogue scale (VAS), was used for the assessment. The VAS is a horizontal 10-cm line with clearly defined boundaries: 0 cm = 'No pain' and 10.0 cm = 'worst possible pain'. partipants made a mark on the line at the point that better described the average pain intensity for their sprained ankle, during the week before testing. The distance marked from the 'no pain' point was measured in mm and was used for data analysis.
Measured: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Present Pain
The third component of the Greek version of the short form of McGill Pain Questionnaire, which is a 6-point verbal rating scale, was used for the assessment. Participants noted what word at the time completing the questionnaire would best describe their pain sensation for the sprained ankle (scoring: no pain = 0, mild = 1, discomforting = 2, distressing = 3, horrible = 4, excruciating = 5). The score corresponding to the noted word was used for data analysis, with higher values representing a worse pain sensation.
Measured: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Ankle Joint Sense for 10° Dorsiflexion
The Biodex isokinetic dynamometer was used for assessment. During testing, participants were blindfolded, in the seated position, with footwear on.The internal goniometer of Biodex recorded the degrees of error for the active repositioning of 10° dorsiflexion (non-weight-bearing) for the sprained ankle, and the mean of three trials was used for analysis.
Measured: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Ankle Joint Sense for 15° Plantar Flexion
The Biodex isokinetic dynamometer was used for assessment. During testing, participants were blindfolded, in the seated position, with footwear on.The internal goniometer of Biodex recorded the degrees of error for the active repositioning of 15° plantar flexion (non-weight-bearing) for the sprained ankle, and the mean of three trials was used for analysis.
Measured: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Ankle Joint Sense for 30° Plantar Flexion
The Biodex isokinetic dynamometer was used for assessment. During testing, participants were blindfolded, in the seated position, with footwear on.The internal goniometer of Biodex recorded the degrees of error for the active repositioning of 30° plantar flexion (non-weight-bearing) for the sprained ankle, and the mean of three trials was used for analysis.
Measured: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Peak Torque of Ankle Dorsiflexor Muscles at 30°/Sec Speed
The Biodex isokinetic dynamometer was used for assessment. During isokinetic testing of the ankle joint, participants were in the seated position, with footwear on. Measurements were taken for the sprained leg, and the mean of five maximal trials was used for analysis.
Measured: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Peak Torque of Ankle Dorsiflexor Muscles at 120°/Sec Speed
The Biodex isokinetic dynamometer was used for assessment. During isokinetic testing of the ankle joint, participants were in the seated position, with footwear on. Measurements were taken for the sprained leg, and the mean of five maximal trials was used for analysis.
Measured: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Peak Torque of Ankle Plantar Flexor Muscles at 30°/Sec Speed
The Biodex isokinetic dynamometer was used for assessment. During isokinetic testing of the ankle joint, participants were in the seated position, with footwear on. Measurements were taken for the sprained leg, and the mean of five maximal trials was used for analysis.
Measured: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Peak Torque of Ankle Plantar Flexor Muscles at 120°/Sec Speed
The Biodex isokinetic dynamometer was used for assessment. During isokinetic testing of the ankle joint, participants were in the seated position, with footwear on. Measurements were taken for the sprained leg, and the mean of five maximal trials was used for analysis.
Measured: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Peak Torque of Foot Evertor Muscles at 30°/Sec Speed
The Biodex isokinetic dynamometer was used for assessment. During isokinetic testing of the subtalar joint, participants were in the seated position, with footwear on. Measurements were taken for the sprained leg, and the mean of five maximal trials was used for analysis.
Measured: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Peak Torque of Foot Evertor Muscles at 120°/Sec Speed
The Biodex isokinetic dynamometer was used for assessment. During isokinetic testing of the subtalar joint, participants were in the seated position, with footwear on. Measurements were taken for the sprained leg, and the mean of five maximal trials was used for analysis.
Measured: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Peak Torque of Foot Invertor Muscles at 30°/Sec Speed
The Biodex isokinetic dynamometer was used for assessment. During isokinetic testing of the subtalar joint, participants were in the seated position, with footwear on. Measurements were taken for the sprained leg, and the mean of five maximal trials was used for analysis.
Measured: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Peak Torque of Foot Invertor Muscles at 120°/Sec Speed
The Biodex isokinetic dynamometer was used for assessment. During isokinetic testing of the subtalar joint, participants were in the seated position, with footwear on. Measurements were taken for the sprained leg, and the mean of five maximal trials was used for analysis.
Measured: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Electromyographic Activity of Anterior Tibialis Muscle During Ankle Dorsiflexion at 30°/Sec Speed
Two surface electrodes and a ground electrode were used for assessment. Measurements were taken for the sprained leg, during isokinetic testing of the ankle dorsiflexor muscles, at 30°/sec speed, with the Biodex dynamometer. Normalized values of the electromyographic (EMG) signals were used for analysis, and EMG activity during maximal voluntary isometric contraction of the anterior tibialis muscle was used as the reference value for normalization.
Measured: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Electromyographic Activity of Anterior Tibialis Muscle During Ankle Dorsiflexion at 120°/Sec Speed
Two surface electrodes and a ground electrode were used for assessment. Measurements were taken for the sprained leg, during isokinetic testing of the ankle dorsiflexor muscles, at 120°/sec speed, with the Biodex dynamometer. Normalized values of the electromyographic (EMG) signals were used for analysis, and EMG activity during maximal voluntary isometric contraction of the anterior tibialis muscle was used as the reference value for normalization.
Measured: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Electromyographic Activity of Peroneus Longus Muscle During Ankle Plantar Flexion at 30°/Sec Speed
Two surface electrodes and a ground electrode were used for assessment. Measurements were taken for the sprained leg, during isokinetic testing of the ankle plantar flexor muscles, at 30°/sec speed, with the Biodex dynamometer. Normalized values of the electromyographic (EMG) signals were used for analysis, and EMG activity during maximal voluntary isometric contraction of the peroneus longus muscle was used as the reference value for normalization.
Measured: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Electromyographic Activity of Peroneus Longus Muscle During Ankle Plantar Flexion at 120°/Sec Speed
Two surface electrodes and a ground electrode were used for assessment. Measurements were taken for the sprained leg, during isokinetic testing of the ankle plantar flexor muscles, at 120°/sec speed, with the Biodex dynamometer. Normalized values of the electromyographic (EMG) signals were used for analysis, and EMG activity during maximal voluntary isometric contraction of the peroneus longus muscle was used as the reference value for normalization.
Measured: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Electromyographic Activity of Peroneus Longus Muscle During Foot Eversion at 30°/Sec Speed
Two surface electrodes and a ground electrode were used for assessment. Measurements were taken for the sprained leg, during isokinetic testing of the foot evertor muscles, at 30°/sec speed, with the Biodex dynamometer. Normalized values of the electromyographic (EMG) signals were used for analysis, and EMG activity during maximal voluntary isometric contraction of the peroneus longus muscle was used as the reference value for normalization.
Measured: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Electromyographic Activity of Peroneus Longus Muscle During Foot Eversion at 120°/Sec Speed
Two surface electrodes and a ground electrode were used for assessment. Measurements were taken for the sprained leg, during isokinetic testing of the foot evertor muscles, at 120°/sec speed, with the Biodex dynamometer. Normalized values of the electromyographic (EMG) signals were used for analysis, and EMG activity during maximal voluntary isometric contraction of the peroneus longus muscle was used as the reference value for normalization.
Measured: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Electromyographic Activity of Tibialis Anterior Muscle During Foot Inversion at 30°/Sec Speed
Two surface electrodes and a ground electrode were used for assessment. Measurements were taken for the sprained leg, during isokinetic testing of the foot invertor muscles, at 30°/sec speed, with the Biodex dynamometer. Normalized values of the electromyographic (EMG) signals were used for analysis, and EMG activity during maximal voluntary isometric contraction of the anterior tibialis muscle was used as the reference value for normalization.
Measured: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Electromyographic Activity of Tibialis Anterior Muscle During Foot Inversion at 120°/Sec Speed
Two surface electrodes and a ground electrode were used for assessment. Measurements were taken for the sprained leg, during isokinetic testing of the foot invertor muscles, at 120°/sec speed, with the Biodex dynamometer. Normalized values of the electromyographic (EMG) signals were used for analysis, and EMG activity during maximal voluntary isometric contraction of the anterior tibialis muscle was used as the reference value for normalization.
Measured: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Participants With Recurrent Ankle Sprain
Measured: Twelve months after the completion of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startDec 2014
- Primary completionNov 2015
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ankle SprainsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lazaros Lazarou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lazaros Lazarou, Aristotle University Of Thessaloniki
- Investigators
- Lazaros S Lazarou, BSc, MSc, Principal investigator, AristotleUniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01853462
- Sponsor's protocol ID
- PNF-123-BAL-SPR
- Status last verified
- Mar 2018
- First submitted
- 9 May 2013
- Last updated
- 1 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Individual participant data will be available only if necessarily required
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Supervised Balance and Proprioceptive Neuromuscular Facilitation Training After Lateral Ligament Sprains of the Ankle
- ClinicalTrials.gov ID
- NCT01853462
- Acronym / sponsor ID
- PNF-123-BAL-SPR
- Conditions
- Ankle Sprains
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Lazaros LazarouUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 15 May 2013 (estimated)
- Results
- Posted 1 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to determine the effects of supervised balance and proprioceptive neuromuscular facilitation (PNF) training for the rehabilitation of ankle sprains
Detailed description
Supervised proprioceptive training has been recommended by recently published guidelines for the rehabilitation of ankle sprains. However, research evidence on the efficacy of this type of training is still weak, mainly owing to the methodological limitations of relevant studies. In addition, there is paucity of evidence concerning the effects of such training for the outcomes of functional performance, pain, ankle range of motion, and contradictory results have been reported for postural control.
This study aimed to substantiate the benefits of supervised training for the rehabilitation of ankle sprains, and elucidate the effects of two different proprioceptive protocols on the above-mentioned outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proprioceptive Neuromuscular Facilitation (PNF) | Experimental | Other: PNF trainingSupervised PNF training |
| Balance | Experimental | Other: Balance trainingSupervised balance training |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Individuals with a symptomatic, conventionally treated, post acute (after 14 days) lateral ankle sprain, Grade I-II
Key exclusion criteria (9 listed)
- Individuals with lateral ankle sprains Grade III
- Individuals with ankle sprain to the medial ligaments
- Individuals with ankle sprain to the interosseous (syndesmotic) ligament
- Individuals with concurrent fracture
- Individuals with chronic ankle instability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PNF trainingTen individual PNF sessions, supervised by a physical therapist, with 50-60 min duration per session, within a maximal five-week period | Other | Proprioceptive Neuromuscular Facilitation (PNF) |
| Balance trainingTen individual balance sessions, supervised by a physical therapist, with 50-60 min duration per session, within a maximal five-week period | Other | Balance |
Primary outcome
Ankle Functional Stability, Via the Single-leg Hop for Distance Test
Time frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Participants hopped, using the sprained leg, as far forward as possible, and remained in the landing position for 2sec. Three trials were performed, and the mean hopping distance was used for analysis.
Ankle Functional Stability, Via the Single-leg Hops for Time Test
Time frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Participants hopped, using the sprained leg, as fast as possible, a six-meter distance. Three trials were performed, and the mean hopping time was used for analysis.
Endurance of Ankle Dorsiflexor Muscles
Time frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
The rising on heel test was used, and participants rose on the heel of the sprained leg, as many times as possible. Scoring:10 points for >40 rises, 5 points for 30-39 rises, 0 points for <30 rises.
Endurance of Ankle Plantar Flexor Muscles
Time frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
The rising on toes test was used, and participants rose on the toes of the sprained leg, as many times as possible. Scoring:10 points for >40 rises, 5 points for 30-39 rises, 0 points for <30 rises.
27 secondary outcomes
Anterior-posterior Stability Index
Time frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Medial-lateral Stability Index
Time frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Overall Stability Index
Time frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Ankle Dorsiflexion Range of Motion
Time frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Pain Sensation
Time frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Pain Intensity During the Week Before Testing
Time frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Present Pain
Time frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Ankle Joint Sense for 10° Dorsiflexion
Time frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Ankle Joint Sense for 15° Plantar Flexion
Time frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Ankle Joint Sense for 30° Plantar Flexion
Time frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Peak Torque of Ankle Dorsiflexor Muscles at 30°/Sec Speed
Time frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Peak Torque of Ankle Dorsiflexor Muscles at 120°/Sec Speed
Time frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Peak Torque of Ankle Plantar Flexor Muscles at 30°/Sec Speed
Time frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Peak Torque of Ankle Plantar Flexor Muscles at 120°/Sec Speed
Time frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Peak Torque of Foot Evertor Muscles at 30°/Sec Speed
Time frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Peak Torque of Foot Evertor Muscles at 120°/Sec Speed
Time frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Peak Torque of Foot Invertor Muscles at 30°/Sec Speed
Time frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Peak Torque of Foot Invertor Muscles at 120°/Sec Speed
Time frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Electromyographic Activity of Anterior Tibialis Muscle During Ankle Dorsiflexion at 30°/Sec Speed
Time frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Electromyographic Activity of Anterior Tibialis Muscle During Ankle Dorsiflexion at 120°/Sec Speed
Time frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Electromyographic Activity of Peroneus Longus Muscle During Ankle Plantar Flexion at 30°/Sec Speed
Time frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Electromyographic Activity of Peroneus Longus Muscle During Ankle Plantar Flexion at 120°/Sec Speed
Time frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Electromyographic Activity of Peroneus Longus Muscle During Foot Eversion at 30°/Sec Speed
Time frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Electromyographic Activity of Peroneus Longus Muscle During Foot Eversion at 120°/Sec Speed
Time frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Electromyographic Activity of Tibialis Anterior Muscle During Foot Inversion at 30°/Sec Speed
Time frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Electromyographic Activity of Tibialis Anterior Muscle During Foot Inversion at 120°/Sec Speed
Time frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Participants With Recurrent Ankle Sprain
Time frame: Twelve months after the completion of training
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. Individual participant data will be available only if necessarily required
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lazaros S Lazarou, BSc, MSc principal investigator
AristotleUniversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PNF training and Balance training in people with Ankle Sprains, run by Lazaros Lazarou at 1 site in Greece.
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 1 inclusion and 9 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 1 Nov 2018. 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 Greece. 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. 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?
Yes. Results are posted in the registry (first posted 1 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Ankle Functional Stability, Via the Single-leg Hop for Distance Test (time frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2018; AzTrials last refreshed its copy on 1 Nov 2026.