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Effects of Two Supervised Training Programs for the Rehabilitation of Ankle Sprains

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ClinicalTrials.gov Identifier: NCT01853462
Recruitment Status : Completed
First Posted : May 15, 2013
Results First Posted : November 1, 2018
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Lazaros Lazarou, Aristotle University Of Thessaloniki

Brief 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

Condition or disease Intervention/treatment Phase
Ankle Sprains Other: PNF training Other: Balance training Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Supervised Balance and Proprioceptive Neuromuscular Facilitation Training After Lateral Ligament Sprains of the Ankle
Study Start Date : December 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : September 2016

Arm Intervention/treatment
Experimental: Proprioceptive Neuromuscular Facilitation (PNF)
Supervised PNF training
Other: PNF training
Ten individual PNF sessions, supervised by a physical therapist, with 50-60 min duration per session, within a maximal five-week period

Experimental: Balance
Supervised balance training
Other: Balance training
Ten individual balance sessions, supervised by a physical therapist, with 50-60 min duration per session, within a maximal five-week period




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


  4. 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.


Secondary Outcome Measures :
  1. 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) ]
    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.

  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) ]
    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.

  3. 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) ]
    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.

  4. 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) ]
    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.

  5. Pain Sensation [ Time Frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2) ]
    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.

  6. 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) ]
    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.

  7. Present Pain [ Time Frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2) ]
    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.

  8. 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) ]
    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.

  9. 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) ]
    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.

  10. 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) ]
    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.

  11. 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) ]
    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.

  12. 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) ]
    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.

  13. 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) ]
    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.

  14. 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) ]
    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.

  15. 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) ]
    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.

  16. 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) ]
    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.

  17. 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) ]
    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.

  18. 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) ]
    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.

  19. 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) ]
    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.

  20. 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) ]
    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.

  21. 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) ]
    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.

  22. 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) ]
    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.

  23. 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) ]
    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.

  24. 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) ]
    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.

  25. 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) ]
    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.

  26. 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) ]
    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.

  27. Participants With Recurrent Ankle Sprain [ Time Frame: Twelve months after the completion of training ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals with a symptomatic, conventionally treated, post acute (after 14 days) lateral ankle sprain, Grade I-II

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01853462


Locations
Greece
Aristotle University
Serres, Agios Ioannis, Greece, 62110
Sponsors and Collaborators
Lazaros Lazarou
Investigators
Principal Investigator: Lazaros S Lazarou, BSc, MSc AristotleUniversity

Responsible Party: Lazaros Lazarou, Physiotherapist (MSc), Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT01853462     History of Changes
Other Study ID Numbers: PNF-123-BAL-SPR
First Posted: May 15, 2013    Key Record Dates
Results First Posted: November 1, 2018
Last Update Posted: November 1, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Individual participant data will be available only if necessarily required

Additional relevant MeSH terms:
Sprains and Strains
Ankle Injuries
Wounds and Injuries
Leg Injuries