Rehabilitation Study Comparing Two Exercise Programs for Ankle Sprains

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 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: December 30, 2014
Last verified: December 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 Exercise Programs -Proprioceptive Neuromuscular Facilitation and Balance- for the Rehabilitation of Ankle Sprains.

Resource links provided by NLM:


Further study details as provided by Aristotle University Of Thessaloniki:

Primary Outcome Measures:
  • Function [ Time Frame: Baseline, after the completion of the intervention, and eight weeks after the completion of the intervention ] [ Designated as safety issue: Yes ]
    Baseline: Before the initiation of the exercise programs (at least 14 days after the sprain -post acute stage) First follow-up measurement: After the completion of the exercise programs (average time period: four weeks after the initiation of the intervention) Second follow-up measurement: Eight weeks after the completion of the exercise programs (average time period: twelve weeks after the initiation of the intervention)


Secondary Outcome Measures:
  • Re-injury rate [ Time Frame: After the completion of the intervention, and eight weeks after the completion of the intervention ] [ Designated as safety issue: Yes ]
    First follow-up measurement: After the completion of the exercise programs (average time period: four weeks after the initiation of the intervention). Second follow-up measurement: Eight weeks after the completion of the exercise programs (average time period: twelve weeks after the initiation of the intervention)

  • Joint position sense [ Time Frame: Baseline, after the completion of the intervention, and eight weeks after the completion of the intervention ] [ Designated as safety issue: Yes ]
    Baseline: Before the initiation of the exercise programs (at least 14 days after the sprain -post acute stage). First follow-up measurement: After the completion of the exercise programs (average time period: four weeks after the initiation of the intervention). Second follow-up measurement: Eight weeks after the completion of the exercise programs (average time period: twelve weeks after the initiation of the intervention)

  • Muscle strength [ Time Frame: Baseline, after the completion of the intervention, and eight weeks after the completion of the intervention ] [ Designated as safety issue: Yes ]
    Baseline: Before the initiation of the exercise programs (at least 14 days after the sprain -post acute stage). First follow-up measurement: After the completion of the exercise programs (average time period: four weeks after the initiation of the intervention).Second follow-up measurement: Eight weeks after the completion of the exercise programs (average time period: twelve weeks after the initiation of the intervention)

  • Electromyographic (EMG) activity [ Time Frame: Baseline, after the completion of the intervention, and eight weeks after the completion of the intervention ] [ Designated as safety issue: Yes ]
    Baseline: Before the initiation of the exercise programs (at least 14 days after the sprain -post acute stage). First follow-up measurement: After the completion of the exercise programs (average time period: four weeks after the initiation of the intervention). Second follow-up measurement: Eight weeks after the completion of the exercise programs (average time period: twelve weeks after the initiation of the intervention)

  • Static balance [ Time Frame: Baseline, after the completion of the intervention, and eight weeks after the completion of the intervention ] [ Designated as safety issue: Yes ]
    Baseline: Before the initiation of the exercise programs (at least 14 days after the sprain -post acute stage). First follow-up measurement: After the completion of the exercise programs (average time period: four weeks after the initiation of the intervention). Second follow-up measurement: Eight weeks after the completion of the exercise programs (average time period: twelve weeks after the initiation of the intervention).

  • Pain [ Time Frame: Baseline, after the completion of the intervention, and eight weeks after the completion of the intervention ] [ Designated as safety issue: Yes ]
    Baseline: Before the initiation of the exercise programs (at least 14 days after the sprain -post acute stage). First follow-up measurement: After the completion of the exercise programs (average time period: four weeks after the initiation of the intervention). Second follow-up measurement: Eight weeks after the completion of the exercise programs (average time period: twelve weeks after the initiation of the intervention).

  • Range of motion [ Time Frame: Baseline, after the completion of the intervention, and eight weeks after the completion of the intervention ] [ Designated as safety issue: Yes ]
    Baseline: Before the initiation of the exercise programs (at least 14 days after the sprain -post acute stage). First follow-up measurement: After the completion of the exercise programs (average time period: four weeks after the initiation of the intervention). Second follow-up measurement: Eight weeks after the completion of the exercise programs (average time period: twelve weeks after the initiation of the intervention).


Estimated Enrollment: 20
Study Start Date: December 2014
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: proprioceptive neuromuscular facilitation
proprioceptive neuromuscular facilitation exercise program
Device: proprioceptive neuromuscular facilitation exercise program
ten individual sessions (approximately one hour per session) of a proprioceptive neuromuscular facilitation exercise program by a physiotherapist
Experimental: balance
balance exercise program
Device: balance exercise program
ten individual sessions (approximately one hour per session) of a balance exercise program by a physiotherapist

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with a symptomatic, non-rehabilitated, post acute (after 14 days) lateral ankle sprain, Grade I-II

Exclusion Criteria:

  • Subjects with lateral ankle sprains Grade III
  • Subjects with concurrent medial ankle sprain
  • Subjects with concurrent syndesmotic ankle sprain
  • Subjects with concurrent fracture
  • Subjects with chronic ankle instability
  • Subjects with history of surgery to the ankles
  • Subjects with history of lower limb nerve injuries
  • Subjects with history of musculoskeletal injury to the non-injured ankle, which is still symptomatic
  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 Recruiting
Serres, Agios Ioannis, Greece, 62110
Contact: Lazaros S Lazarou, BSc, MSc    0030 6947560795    lazarosphysiotherapist@gmail.com   
Principal Investigator: Lazaros S Lazarou, BSc, MSc         
Sponsors and Collaborators
Lazaros Lazarou
Investigators
Principal Investigator: Lazaros S Lazarou, BSc, MSc AristotleUniversity
  More Information

No publications provided

Responsible Party: Lazaros Lazarou, Physiotherapist, Lecturer of Physiotherapy (MSc, BSc), 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: December 30, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 05, 2015