NCT01853462

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 15, 2013

Completed
1.5 years until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

November 1, 2018

Completed
Last Updated

November 1, 2018

Status Verified

March 1, 2018

Enrollment Period

11 months

First QC Date

May 9, 2013

Results QC Date

October 3, 2016

Last Update Submit

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)

EXPERIMENTAL

Supervised PNF training

Other: PNF training

Balance

EXPERIMENTAL

Supervised balance training

Other: 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

Proprioceptive Neuromuscular Facilitation (PNF)

Ten individual balance sessions, supervised by a physical therapist, with 50-60 min duration per session, within a maximal five-week period

Balance

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Study Sites (1)

Aristotle University

Serres, Agios Ioannis, 62110, Greece

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Results Point of Contact

Title
Lazaros Lazarou
Organization
Aristotle University of Thessaloniki

Study Officials

  • Lazaros S Lazarou, BSc, MSc

    AristotleUniversity

    PRINCIPAL INVESTIGATOR

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

Locations