Rehabilitation Study Comparing Two Exercise Programs for Ankle Sprains

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by Aristotle University Of Thessaloniki
Sponsor:
Information provided by (Responsible Party):
Lazaros Lazarou, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT01853462
First received: May 9, 2013
Last updated: April 19, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to determine the comparative effectiveness of proprioceptive neuromuscular facilitation and balance exercise programs for the rehabilitation of ankle sprain injuries.


Condition Intervention
Ankle Sprains
Device: proprioceptive neuromuscular facilitation exercise program
Device: balance exercise program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Two Programs - Proprioceptive Neuromuscular Facilitation and Balance Exercises - for the Rehabilitation of Ankle Sprains.

Resource links provided by NLM:


Further study details as provided by Aristotle University Of Thessaloniki:

Primary Outcome Measures:
  • Joint position sense (JPS) [ Time Frame: Baseline, at the completion and three months after the completion of the proprioceptive neuromuscular facilitation and balance exercise programs ] [ Designated as safety issue: Yes ]

    Baseline: At the commencement of exercise programs (average time period: 2-3 weeks after the injury). First follow-up measurement: Changes in JPS at the completion of exercise programs (average time period: 4-6 weeks after the injury). Second follow-up measurement: Changes in JPS three months after the completion of exercise programs (average time period: 16-18 weeks after the injury).

    Objective assessment

    • Bilateral active ankle position sense measurements for 10° of inversion, 20° of inversion and 10° of eversion, via a calibrated isokinetic dynamometer/ Metrics: For each lower extremity, the mean score of two trials for each position will be used in data analysis


  • Static balance [ Time Frame: Baseline, at the completion and three months after the completion of the proprioceptive neuromuscular facilitation and balance exercise programs ] [ Designated as safety issue: Yes ]

    Baseline: At the commencement of exercise programs (average time period: 2-3 weeks after the injury). First follow-up measurement: Changes in function at the completion of exercise programs (average time period: 4-6 weeks after the injury). Second follow-up measurement: Changes in function three months after the completion of exercise programs (average time period: 16-18 weeks after the injury).

    Objective assessment

    • Bilateral postural sway measurements, via a force platform, with subjects standing on one leg for 30 seconds, with eyes open and arms folded across the chest/ Metrics: For each lower extremity, the mean score of three trials will be used in data analysis


  • Muscle strength [ Time Frame: Baseline, at the completion and three months after the completion of the proprioceptive neuromuscular facilitation and balance exercise programs ] [ Designated as safety issue: Yes ]

    Baseline: At the commencement of exercise programs (average time period: 2-3 weeks after the injury). First follow-up measurement: Changes in muscle strength at the completion of exercise programs (average time period: 4-6 weeks after the injury). Second follow-up measurement: Changes in muscle strength three months after the completion of exercise programs (average time period: 16-18 weeks after the injury).

    Objective assessment

    • Bilateral isometric ankle strength measurements for dorsiflexion, plantar flexion, inversion and eversion, via a calibrated isokinetic dynamometer/ Metrics: For each lower extremity, the mean score of three trials for each movement will be used in data analysis


  • Electromyographic (EMG) activity [ Time Frame: Baseline, at the completion and three months after the completion of the proprioceptive neuromuscular facilitation and balance exercise programs ] [ Designated as safety issue: Yes ]

    Baseline: At the commencement of exercise programs (average time period: 2-3 weeks after the injury). First follow-up measurement: Changes in EMG activity at the completion of exercise programs (average time period: 4-6 weeks after the injury). Second follow-up measurement: Changes in EMG activity three months after the completion of exercise programs (average time period: 16-18 weeks after the injury).

    Objective assessment

    • Bilateral EMG activity of the peroneal long muscles, via surface electromyography, during ankle strength measurements for eversion/ Metrics: For each lower extremity, the mean EMG activity of three trials will be used in data analysis


  • Range of motion (ROM) [ Time Frame: Baseline, at the completion and three months after the completion of the proprioceptive neuromuscular facilitation and balance exercise programs ] [ Designated as safety issue: Yes ]

    Baseline: At the commencement of exercise programs (average time period: 2-3 weeks after the injury). First follow-up measurement: Changes in ROM at the completion of exercise programs (average time period: 4-6 weeks after the injury). Second follow-up measurement: Changes in ROM three months after the completion of exercise programs (average time period: 16-18 weeks after the injury).

    Objective assessment

    • Bilateral passive ROM measurements for ankle plantar and dorsi flexion, via a goniometer/ Metrics: For each lower extremity, the mean score of three trials for each movement will be used in data analysis


  • Function [ Time Frame: Baseline, at the completion and three months after the completion of the proprioceptive neuromuscular facilitation and balance exercise programs ] [ Designated as safety issue: Yes ]

    Baseline: At the commencement of exercise programs (average time period: 2-3 weeks after the injury). First follow-up measurement: Changes in function at the completion of exercise programs (average time period: 4-6 weeks after the injury). Second follow-up measurement: Changes in function three months after the completion of exercise programs (average time period: 16-18 weeks after the injury).

    Objective assessment

    • Performance of 3 functional tests, i.e. rising on toes (bilateral), rising on heels (bilateral) and walking down a staircase/ Metrics: A scoring scale, which is a standardized test protocol
    • Bilateral performance of 2 functional stability tests (single-leg hops for distance, single-leg hops for time)/Metrics: For each lower extremity, the mean score of three trials for each test will be used in data analysis

  • Pain [ Time Frame: Baseline, at the completion and three months after the completion of the proprioceptive neuromuscular facilitation and balance exercise programs ] [ Designated as safety issue: Yes ]

    Baseline: At the commencement of exercise programs (average time period: 2-3 weeks after the injury). First follow-up measurement: Changes in pain at the completion of exercise programs (average time period: 4-6 weeks after the injury). Second follow-up measurement: Changes in pain three months after the completion of exercise programs (average time period: 16-18 weeks after the injury).

    Objective and subjective assessment

    • Bilateral pressure pain threshold measurements over the anterior talofibular and calcaneofibular ligaments, via an algometer/ Metrics: For each lower extremity, the mean score of three trials for each ligament will be used in data analysis
    • A valid and reliable questionnaire, standardized in Greek

  • Re-injury rate [ Time Frame: Three months after the completion of the proprioceptive neuromuscular facilitation and balance exercise programs ] [ Designated as safety issue: Yes ]

    Re-injury rate three months after the completion of exercise programs (average time period: 16-18 weeks after the injury).

    Subjective assessment

    • Re-injury rate (95% CI), via telephone conversation /Metrics: An injury-screening questionnaire



Secondary Outcome Measures:
  • Re-injury rate [ Time Frame: Twelve months after the completion of the proprioceptive neuromuscular facilitation and balance exercise programs ] [ Designated as safety issue: Yes ]

    Re-injury rate twelve months after the completion of exercise programs (average time period: 13-13.5 months after the injury).

    Subjective assessment

    • Re-injury rate (95% CI), via telephone conversation /Metrics: An injury-screening questionnaire



Estimated Enrollment: 20
Study Start Date: August 2014
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: proprioceptive neuromuscular facilitation
four individual physiotherapy sessions (one hour per session) of early exercises followed by eight individual physiotherapy sessions (one hour per session) of a proprioceptive neuromuscular facilitation exercise program
Device: proprioceptive neuromuscular facilitation exercise program
eight individual sessions (one hour per session) by a physiotherapist
Experimental: balance
four individual physiotherapy sessions (one hour per session) of early exercises followed by eight individual physiotherapy sessions (one hour per session) of a balance exercise program
Device: balance exercise program
eight individual sessions (one hour per session) by a physiotherapist

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with subacute lateral ankle sprains, Grade I-II, who asked for medical advice within one week of injury

Exclusion Criteria:

  • Subjects with lateral ankle sprains, Grade I-II, who have history of ankle injuries during the previous two years
  • Subjects with lateral ankle sprains Grade III
  • Subjects with medial ankle sprains
  • Subjects with syndesmotic ankle sprains
  • Subjects with concomitant fractures or other musculoskeletal problems to the injured ankle
  • Subjects with history of lower limb nerve injuries
  • Subjects with chronic ankle instability
  • Subjects with history of surgery to the ankles
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01853462

Contacts
Contact: Lazaros S Lazarou, BSc, MSc 0030 6947560795 lazarosphysiotherapist@gmail.com

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

No publications provided

Responsible Party: Lazaros Lazarou, Physiotherapist, Lecturer of Physiotherapy (BSc, MSc), Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT01853462     History of Changes
Other Study ID Numbers: PNF-123-BAL-SPR
Study First Received: May 9, 2013
Last Updated: April 19, 2014
Health Authority: Greece: Ministry of Health and Welfare

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

ClinicalTrials.gov processed this record on August 28, 2014