Clinical trial NCT01853462: Effects of Two Supervised Training Programs for the Rehabilitation of Ankle Sprains
Official title: Effects of Supervised Balance and Proprioceptive Neuromuscular Facilitation Training After Lateral Ligament Sprains of the Ankle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Sprains
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2013-05-15
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: Ankle Functional Stability, Via the Single-leg Hop for Distance Test
timeFrame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
measure: Ankle Functional Stability, Via the Single-leg Hops for Time Test
timeFrame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
measure: Endurance of Ankle Dorsiflexor Muscles
timeFrame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
measure: Endurance of Ankle Plantar Flexor Muscles
timeFrame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Secondary outcomes:
measure: Anterior-posterior Stability Index
timeFrame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
measure: Medial-lateral Stability Index
timeFrame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
measure: Overall Stability Index
timeFrame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
measure: Ankle Dorsiflexion Range of Motion
timeFrame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
measure: Pain Sensation
timeFrame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
measure: Pain Intensity During the Week Before Testing
timeFrame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
measure: Present Pain
timeFrame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
measure: Ankle Joint Sense for 10° Dorsiflexion
timeFrame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
measure: Ankle Joint Sense for 15° Plantar Flexion
timeFrame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
measure: Ankle Joint Sense for 30° Plantar Flexion
timeFrame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
measure: Peak Torque of Ankle Dorsiflexor Muscles at 30°/Sec Speed
timeFrame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
measure: Peak Torque of Ankle Dorsiflexor Muscles at 120°/Sec Speed
timeFrame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
measure: Peak Torque of Ankle Plantar Flexor Muscles at 30°/Sec Speed
timeFrame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
measure: Peak Torque of Ankle Plantar Flexor Muscles at 120°/Sec Speed
timeFrame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
measure: Peak Torque of Foot Evertor Muscles at 30°/Sec Speed
timeFrame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
measure: Peak Torque of Foot Evertor Muscles at 120°/Sec Speed
timeFrame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
measure: Peak Torque of Foot Invertor Muscles at 30°/Sec Speed
timeFrame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
measure: Peak Torque of Foot Invertor Muscles at 120°/Sec Speed
timeFrame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
measure: Electromyographic Activity of Anterior Tibialis Muscle During Ankle Dorsiflexion at 30°/Sec Speed
timeFrame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
measure: Electromyographic Activity of Anterior Tibialis Muscle During Ankle Dorsiflexion at 120°/Sec Speed
timeFrame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
measure: Electromyographic Activity of Peroneus Longus Muscle During Ankle Plantar Flexion at 30°/Sec Speed
timeFrame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
measure: Electromyographic Activity of Peroneus Longus Muscle During Ankle Plantar Flexion at 120°/Sec Speed
timeFrame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
measure: Electromyographic Activity of Peroneus Longus Muscle During Foot Eversion at 30°/Sec Speed
timeFrame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
measure: Electromyographic Activity of Peroneus Longus Muscle During Foot Eversion at 120°/Sec Speed
timeFrame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
measure: Electromyographic Activity of Tibialis Anterior Muscle During Foot Inversion at 30°/Sec Speed
timeFrame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
measure: Electromyographic Activity of Tibialis Anterior Muscle During Foot Inversion at 120°/Sec Speed
timeFrame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
measure: Participants With Recurrent Ankle Sprain
timeFrame: Twelve months after the completion of training
Other outcomes:
Locations:
city: Serres
country: Greece
facility: Aristotle University
state: Agios Ioannis
Study officials:
affiliation: AristotleUniversity
name: Lazaros S Lazarou, BSc, MSc
role: PRINCIPAL_INVESTIGATOR
References: