Effects of Two Supervised Training Programs for the Rehabilitation of Ankle Sprains
Effects of Supervised Balance and Proprioceptive Neuromuscular Facilitation Training After Lateral Ligament Sprains of the Ankle
1 other identifier
interventional
22
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2013
CompletedFirst Posted
Study publicly available on registry
May 15, 2013
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedResults Posted
Study results publicly available
November 1, 2018
CompletedNovember 1, 2018
March 1, 2018
11 months
May 9, 2013
October 3, 2016
March 4, 2018
Conditions
Outcome Measures
Primary Outcomes (4)
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.
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.
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.
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.
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
Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Medial-lateral Stability Index
Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Overall Stability Index
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
Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
Pain Sensation
Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)
- +22 more secondary outcomes
Study Arms (2)
Proprioceptive Neuromuscular Facilitation (PNF)
EXPERIMENTALSupervised PNF training
Balance
EXPERIMENTALSupervised balance training
Interventions
Ten individual PNF sessions, supervised by a physical therapist, with 50-60 min duration per session, within a maximal five-week period
Ten individual balance sessions, supervised by a physical therapist, with 50-60 min duration per session, within a maximal five-week period
Eligibility Criteria
You may qualify if:
- Individuals with a symptomatic, conventionally treated, post acute (after 14 days) lateral ankle sprain, Grade I-II
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lazaros Lazaroulead
Study Sites (1)
Aristotle University
Serres, Agios Ioannis, 62110, Greece
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lazaros Lazarou
- Organization
- Aristotle University of Thessaloniki
Study Officials
- PRINCIPAL INVESTIGATOR
Lazaros S Lazarou, BSc, MSc
AristotleUniversity
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Physiotherapist (MSc)
Study Record Dates
First Submitted
May 9, 2013
First Posted
May 15, 2013
Study Start
December 1, 2014
Primary Completion
November 1, 2015
Study Completion
September 1, 2016
Last Updated
November 1, 2018
Results First Posted
November 1, 2018
Record last verified: 2018-03