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Rehabilitation Study Comparing Two Exercise Programs for Ankle Sprains

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ClinicalTrials.gov Identifier: NCT01853462
Recruitment Status : Completed
First Posted : May 15, 2013
Last Update Posted : October 27, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Ankle Sprains Device: proprioceptive neuromuscular facilitation exercise program Device: balance exercise program

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Two Exercise Programs -Proprioceptive Neuromuscular Facilitation and Balance- for the Rehabilitation of Ankle Sprains.
Study Start Date : December 2014
Primary Completion Date : October 2015
Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Function [ Time Frame: Baseline, after the completion of the intervention, and eight weeks after the completion of the intervention ]
    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 :
  1. Re-injury rate [ Time Frame: After the completion of the intervention, and eight weeks after the completion of the intervention ]
    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)

  2. Joint position sense [ Time Frame: Baseline, after the completion of the intervention, and eight weeks after the completion of the intervention ]
    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)

  3. Muscle strength [ Time Frame: Baseline, after the completion of the intervention, and eight weeks after the completion of the intervention ]
    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)

  4. Electromyographic (EMG) activity [ Time Frame: Baseline, after the completion of the intervention, and eight weeks after the completion of the intervention ]
    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)

  5. Static balance [ Time Frame: Baseline, after the completion of the intervention, and eight weeks after the completion of the intervention ]
    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).

  6. Pain [ Time Frame: Baseline, after the completion of the intervention, and eight weeks after the completion of the intervention ]
    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).

  7. Range of motion [ Time Frame: Baseline, after the completion of the intervention, and eight weeks after the completion of the intervention ]
    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).


Eligibility Criteria

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:

  • 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

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
More Information

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
First Posted: May 15, 2013    Key Record Dates
Last Update Posted: October 27, 2015
Last Verified: October 2015

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