Trial Outcomes & Findings for Effects of Two Supervised Training Programs for the Rehabilitation of Ankle Sprains (NCT NCT01853462)

NCT ID: NCT01853462

Last Updated: 2018-11-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)

Results posted on

2018-11-01

Participant Flow

Participant milestones

Participant milestones
Measure
Proprioceptive Neuromuscular Facilitation (PNF)
PNF training proprioceptive neuromuscular facilitation exercise program: Ten individual sessions (50-60min per session) of PNF training, supervised by a physical therapist
Balance
Balance training balance exercise program: Ten individual sessions (50-60min per session) of balance training, supervised by a physical therapist
Overall Study
STARTED
11
11
Overall Study
COMPLETED
10
10
Overall Study
NOT COMPLETED
1
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Proprioceptive Neuromuscular Facilitation (PNF)
PNF training proprioceptive neuromuscular facilitation exercise program: Ten individual sessions (50-60min per session) of PNF training, supervised by a physical therapist
Balance
Balance training balance exercise program: Ten individual sessions (50-60min per session) of balance training, supervised by a physical therapist
Overall Study
Withdrawal by Subject
1
1

Baseline Characteristics

Effects of Two Supervised Training Programs for the Rehabilitation of Ankle Sprains

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Proprioceptive Neuromuscular Facilitation (PNF)
n=10 Participants
PNF training proprioceptive neuromuscular facilitation exercise program: Ten individual sessions (50-60min per session) of PNF training, supervised by a physical therapist
Balance
n=10 Participants
Balance training balance exercise program: Ten individual sessions (50-60min per session) of balance training, supervised by a physical therapist
Total
n=20 Participants
Total of all reporting groups
Age, Continuous
21.8 years
STANDARD_DEVIATION 3.8 • n=5 Participants
21.5 years
STANDARD_DEVIATION 1.8 • n=7 Participants
21.7 years
STANDARD_DEVIATION 2.9 • n=5 Participants
Sex: Female, Male
Female
7 Participants
n=5 Participants
7 Participants
n=7 Participants
14 Participants
n=5 Participants
Sex: Female, Male
Male
3 Participants
n=5 Participants
3 Participants
n=7 Participants
6 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)

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.

Outcome measures

Outcome measures
Measure
Proprioceptive Neuromuscular Facilitation (PNF)
n=10 Participants
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Balance
n=10 Participants
Supervised Balance Training
Ankle Functional Stability, Via the Single-leg Hop for Distance Test
Baseline
65.6 Centimeters
Standard Deviation 17.0
82.8 Centimeters
Standard Deviation 19.5
Ankle Functional Stability, Via the Single-leg Hop for Distance Test
Follow-up 1
100.3 Centimeters
Standard Deviation 17.0
101.4 Centimeters
Standard Deviation 29.8
Ankle Functional Stability, Via the Single-leg Hop for Distance Test
Follow-up 2
77.0 Centimeters
Standard Deviation 17.6
110.0 Centimeters
Standard Deviation 30.5

PRIMARY outcome

Timeframe: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)

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.

Outcome measures

Outcome measures
Measure
Proprioceptive Neuromuscular Facilitation (PNF)
n=10 Participants
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Balance
n=10 Participants
Supervised Balance Training
Ankle Functional Stability, Via the Single-leg Hops for Time Test
Follow-up 1
2.1 Seconds
Standard Deviation 0.2
2.7 Seconds
Standard Deviation 0.4
Ankle Functional Stability, Via the Single-leg Hops for Time Test
Follow-up 2
2.1 Seconds
Standard Deviation 0.3
2.2 Seconds
Standard Deviation 0.4
Ankle Functional Stability, Via the Single-leg Hops for Time Test
Baseline
2.9 Seconds
Standard Deviation 0.6
3.3 Seconds
Standard Deviation 0.4

PRIMARY outcome

Timeframe: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)

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.

Outcome measures

Outcome measures
Measure
Proprioceptive Neuromuscular Facilitation (PNF)
n=10 Participants
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Balance
n=10 Participants
Supervised Balance Training
Endurance of Ankle Dorsiflexor Muscles
Baseline
0 points on a scale
Interval 0.0 to 10.0
5 points on a scale
Interval 0.0 to 10.0
Endurance of Ankle Dorsiflexor Muscles
Follow-up 1
10 points on a scale
Interval 5.0 to 10.0
10 points on a scale
Interval 5.0 to 10.0
Endurance of Ankle Dorsiflexor Muscles
Follow-up 2
7.5 points on a scale
Interval 0.0 to 10.0
10 points on a scale
Interval 5.0 to 10.0

PRIMARY outcome

Timeframe: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)

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.

Outcome measures

Outcome measures
Measure
Proprioceptive Neuromuscular Facilitation (PNF)
n=10 Participants
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Balance
n=10 Participants
Supervised Balance Training
Endurance of Ankle Plantar Flexor Muscles
Baseline
0 points on a scale
Interval 0.0 to 0.0
0 points on a scale
Interval 0.0 to 0.0
Endurance of Ankle Plantar Flexor Muscles
Follow-up 1
5 points on a scale
Interval 0.0 to 10.0
7.5 points on a scale
Interval 0.0 to 10.0
Endurance of Ankle Plantar Flexor Muscles
Follow-up 2
7.5 points on a scale
Interval 0.0 to 10.0
7.5 points on a scale
Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)

The Biodex Stability System, which is a dynamic tilting platform, was used for assessment. The anterior-posterior stability index corresponded to the variance of foot platform displacement in the sagittal plane, and it was measured in single-leg stance, for the sprained leg, without footwear. Three 20-sec trials were performed, with open eyes, and the mean score was used for analysis.

Outcome measures

Outcome measures
Measure
Proprioceptive Neuromuscular Facilitation (PNF)
n=10 Participants
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Balance
n=10 Participants
Supervised Balance Training
Anterior-posterior Stability Index
Baseline
2.6 Degrees
Standard Deviation 0.6
3.1 Degrees
Standard Deviation 0.6
Anterior-posterior Stability Index
Follow-up 1
2.6 Degrees
Standard Deviation 0.3
3.0 Degrees
Standard Deviation 0.7
Anterior-posterior Stability Index
Follow-up 2
2.5 Degrees
Standard Deviation 0.4
3.1 Degrees
Standard Deviation 0.7

SECONDARY outcome

Timeframe: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)

The Biodex Stability System, which is a dynamic tilting platform, was used for assessment. The medial-lateral stability index corresponded to the variance of foot platform displacement in the frontal plane, and it was measured in single-leg stance, for the sprained leg, without footwear. Three 20-sec trials were performed, with open eyes, and the mean score was used for analysis.

Outcome measures

Outcome measures
Measure
Proprioceptive Neuromuscular Facilitation (PNF)
n=10 Participants
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Balance
n=10 Participants
Supervised Balance Training
Medial-lateral Stability Index
Baseline
1.9 Degrees
Standard Deviation 0.5
1.9 Degrees
Standard Deviation 0.4
Medial-lateral Stability Index
Follow-up 1
1.7 Degrees
Standard Deviation 0.5
2.0 Degrees
Standard Deviation 0.5
Medial-lateral Stability Index
Follow-up 2
1.6 Degrees
Standard Deviation 0.4
1.5 Degrees
Standard Deviation 0.3

SECONDARY outcome

Timeframe: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)

The Biodex Stability System, which is a dynamic tilting platform, was used for assessment. The overall stability index corresponded to the variance of foot platform overall displacement, and it was measured in single-leg stance, for the sprained leg, without footwear. Three 20-sec trials were performed, with open eyes, and the mean score was used for analysis.

Outcome measures

Outcome measures
Measure
Proprioceptive Neuromuscular Facilitation (PNF)
n=10 Participants
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Balance
n=10 Participants
Supervised Balance Training
Overall Stability Index
Baseline
3.1 Degrees
Standard Deviation 0.7
3.6 Degrees
Standard Deviation 0.8
Overall Stability Index
Follow-up 1
3.0 Degrees
Standard Deviation 0.6
3.4 Degrees
Standard Deviation 0.5
Overall Stability Index
Follow-up 2
2.9 Degrees
Standard Deviation 0.6
3.4 Degrees
Standard Deviation 0.6

SECONDARY outcome

Timeframe: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)

Assessement was performed with a goniometer. Participants actively dorsiflexed the sprained ankle, while being in long sitting, on a physical therapy table. The mean score of three measurements was used for analysis.

Outcome measures

Outcome measures
Measure
Proprioceptive Neuromuscular Facilitation (PNF)
n=10 Participants
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Balance
n=10 Participants
Supervised Balance Training
Ankle Dorsiflexion Range of Motion
Follow-up 2
15 Degrees
Standard Deviation 2
15 Degrees
Standard Deviation 1
Ankle Dorsiflexion Range of Motion
Baseline
7 Degrees
Standard Deviation 3
8 Degrees
Standard Deviation 2
Ankle Dorsiflexion Range of Motion
Follow-up 1
13 Degrees
Standard Deviation 3
15 Degrees
Standard Deviation 2

SECONDARY outcome

Timeframe: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)

The main component of the Greek version of the short form of McGill Pain Questionnaire (GR-SFMPQ) was used for the assessment of pain sensation of the sprained ankle. This consists of 15 descriptive adjectives for the pain sensation (11 sensory and 4 affective), which are self-rated according to their intensity level on a 4-point rating scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). The total rating score (minimum = 0, maximum = 45) of the main component of the GR-SFMPQ was used for data analysis, with higher values representing a worse pain sensation.

Outcome measures

Outcome measures
Measure
Proprioceptive Neuromuscular Facilitation (PNF)
n=10 Participants
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Balance
n=10 Participants
Supervised Balance Training
Pain Sensation
Follow-up 1
0 Total score of scales
Interval 0.0 to 2.0
0 Total score of scales
Interval 0.0 to 2.0
Pain Sensation
Follow-up 2
3.5 Total score of scales
Interval 0.0 to 10.0
0.5 Total score of scales
Interval 0.0 to 1.0
Pain Sensation
Baseline
7 Total score of scales
Interval 1.0 to 12.0
6 Total score of scales
Interval 2.0 to 10.0

SECONDARY outcome

Timeframe: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)

The second component of the Greek version of the short form of McGill Pain Questionnaire, which is a visual analogue scale (VAS), was used for the assessment. The VAS is a horizontal 10-cm line with clearly defined boundaries: 0 cm = 'No pain' and 10.0 cm = 'worst possible pain'. partipants made a mark on the line at the point that better described the average pain intensity for their sprained ankle, during the week before testing. The distance marked from the 'no pain' point was measured in mm and was used for data analysis.

Outcome measures

Outcome measures
Measure
Proprioceptive Neuromuscular Facilitation (PNF)
n=10 Participants
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Balance
n=10 Participants
Supervised Balance Training
Pain Intensity During the Week Before Testing
Follow-up 1
0.4 Points on a scale
Standard Deviation 0.4
1.1 Points on a scale
Standard Deviation 1.3
Pain Intensity During the Week Before Testing
Baseline
2.0 Points on a scale
Standard Deviation 1.6
2.8 Points on a scale
Standard Deviation 2.1
Pain Intensity During the Week Before Testing
Follow-up 2
1.3 Points on a scale
Standard Deviation 1.0
0.5 Points on a scale
Standard Deviation 0.7

SECONDARY outcome

Timeframe: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)

The third component of the Greek version of the short form of McGill Pain Questionnaire, which is a 6-point verbal rating scale, was used for the assessment. Participants noted what word at the time completing the questionnaire would best describe their pain sensation for the sprained ankle (scoring: no pain = 0, mild = 1, discomforting = 2, distressing = 3, horrible = 4, excruciating = 5). The score corresponding to the noted word was used for data analysis, with higher values representing a worse pain sensation.

Outcome measures

Outcome measures
Measure
Proprioceptive Neuromuscular Facilitation (PNF)
n=10 Participants
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Balance
n=10 Participants
Supervised Balance Training
Present Pain
Baseline
1 Points on a scale
Interval 0.0 to 2.0
1 Points on a scale
Interval 0.0 to 2.0
Present Pain
Follow-up 1
0 Points on a scale
Interval 0.0 to 1.0
0 Points on a scale
Interval 0.0 to 1.0
Present Pain
Follow-up 2
1 Points on a scale
Interval 0.0 to 2.0
0 Points on a scale
Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)

The Biodex isokinetic dynamometer was used for assessment. During testing, participants were blindfolded, in the seated position, with footwear on.The internal goniometer of Biodex recorded the degrees of error for the active repositioning of 10° dorsiflexion (non-weight-bearing) for the sprained ankle, and the mean of three trials was used for analysis.

Outcome measures

Outcome measures
Measure
Proprioceptive Neuromuscular Facilitation (PNF)
n=10 Participants
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Balance
n=10 Participants
Supervised Balance Training
Ankle Joint Sense for 10° Dorsiflexion
Baseline
4 Degrees
Standard Deviation 2
6 Degrees
Standard Deviation 4
Ankle Joint Sense for 10° Dorsiflexion
Follow-up 1
1 Degrees
Standard Deviation 1
3 Degrees
Standard Deviation 3
Ankle Joint Sense for 10° Dorsiflexion
Follow-up 2
5 Degrees
Standard Deviation 3
4 Degrees
Standard Deviation 2

SECONDARY outcome

Timeframe: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)

The Biodex isokinetic dynamometer was used for assessment. During testing, participants were blindfolded, in the seated position, with footwear on.The internal goniometer of Biodex recorded the degrees of error for the active repositioning of 15° plantar flexion (non-weight-bearing) for the sprained ankle, and the mean of three trials was used for analysis.

Outcome measures

Outcome measures
Measure
Proprioceptive Neuromuscular Facilitation (PNF)
n=10 Participants
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Balance
n=10 Participants
Supervised Balance Training
Ankle Joint Sense for 15° Plantar Flexion
Baseline
10 Degrees
Standard Deviation 4
9 Degrees
Standard Deviation 4
Ankle Joint Sense for 15° Plantar Flexion
Follow-up 1
7 Degrees
Standard Deviation 3
5 Degrees
Standard Deviation 1
Ankle Joint Sense for 15° Plantar Flexion
Follow-up 2
8 Degrees
Standard Deviation 3
5 Degrees
Standard Deviation 1

SECONDARY outcome

Timeframe: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)

The Biodex isokinetic dynamometer was used for assessment. During testing, participants were blindfolded, in the seated position, with footwear on.The internal goniometer of Biodex recorded the degrees of error for the active repositioning of 30° plantar flexion (non-weight-bearing) for the sprained ankle, and the mean of three trials was used for analysis.

Outcome measures

Outcome measures
Measure
Proprioceptive Neuromuscular Facilitation (PNF)
n=10 Participants
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Balance
n=10 Participants
Supervised Balance Training
Ankle Joint Sense for 30° Plantar Flexion
Baseline
7 Degrees
Standard Deviation 6
4 Degrees
Standard Deviation 3
Ankle Joint Sense for 30° Plantar Flexion
Follow-up 2
5 Degrees
Standard Deviation 2
3 Degrees
Standard Deviation 2
Ankle Joint Sense for 30° Plantar Flexion
Follow-up 1
4 Degrees
Standard Deviation 2
3 Degrees
Standard Deviation 1

SECONDARY outcome

Timeframe: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)

The Biodex isokinetic dynamometer was used for assessment. During isokinetic testing of the ankle joint, participants were in the seated position, with footwear on. Measurements were taken for the sprained leg, and the mean of five maximal trials was used for analysis.

Outcome measures

Outcome measures
Measure
Proprioceptive Neuromuscular Facilitation (PNF)
n=10 Participants
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Balance
n=10 Participants
Supervised Balance Training
Peak Torque of Ankle Dorsiflexor Muscles at 30°/Sec Speed
Follow-up 2
30.8 Newton metres
Standard Deviation 5.8
30.3 Newton metres
Standard Deviation 7.3
Peak Torque of Ankle Dorsiflexor Muscles at 30°/Sec Speed
Baseline
35.8 Newton metres
Standard Deviation 8.2
31.7 Newton metres
Standard Deviation 6.8
Peak Torque of Ankle Dorsiflexor Muscles at 30°/Sec Speed
Follow-up 1
30.7 Newton metres
Standard Deviation 7.3
32.3 Newton metres
Standard Deviation 8.6

SECONDARY outcome

Timeframe: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)

The Biodex isokinetic dynamometer was used for assessment. During isokinetic testing of the ankle joint, participants were in the seated position, with footwear on. Measurements were taken for the sprained leg, and the mean of five maximal trials was used for analysis.

Outcome measures

Outcome measures
Measure
Proprioceptive Neuromuscular Facilitation (PNF)
n=10 Participants
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Balance
n=10 Participants
Supervised Balance Training
Peak Torque of Ankle Dorsiflexor Muscles at 120°/Sec Speed
Follow-up 2
19.4 Newton metres
Standard Deviation 4.1
22.1 Newton metres
Standard Deviation 5.5
Peak Torque of Ankle Dorsiflexor Muscles at 120°/Sec Speed
Baseline
20.3 Newton metres
Standard Deviation 4.2
22.7 Newton metres
Standard Deviation 5.9
Peak Torque of Ankle Dorsiflexor Muscles at 120°/Sec Speed
Follow-up 1
19.0 Newton metres
Standard Deviation 5.4
21.4 Newton metres
Standard Deviation 5.5

SECONDARY outcome

Timeframe: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)

The Biodex isokinetic dynamometer was used for assessment. During isokinetic testing of the ankle joint, participants were in the seated position, with footwear on. Measurements were taken for the sprained leg, and the mean of five maximal trials was used for analysis.

Outcome measures

Outcome measures
Measure
Proprioceptive Neuromuscular Facilitation (PNF)
n=10 Participants
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Balance
n=10 Participants
Supervised Balance Training
Peak Torque of Ankle Plantar Flexor Muscles at 30°/Sec Speed
Follow-up 1
46.1 Newton metres
Standard Deviation 11.3
80.6 Newton metres
Standard Deviation 31.4
Peak Torque of Ankle Plantar Flexor Muscles at 30°/Sec Speed
Follow-up 2
53.5 Newton metres
Standard Deviation 14.7
65.5 Newton metres
Standard Deviation 25.5
Peak Torque of Ankle Plantar Flexor Muscles at 30°/Sec Speed
Baseline
31.5 Newton metres
Standard Deviation 13.8
47.8 Newton metres
Standard Deviation 23.6

SECONDARY outcome

Timeframe: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)

The Biodex isokinetic dynamometer was used for assessment. During isokinetic testing of the ankle joint, participants were in the seated position, with footwear on. Measurements were taken for the sprained leg, and the mean of five maximal trials was used for analysis.

Outcome measures

Outcome measures
Measure
Proprioceptive Neuromuscular Facilitation (PNF)
n=10 Participants
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Balance
n=10 Participants
Supervised Balance Training
Peak Torque of Ankle Plantar Flexor Muscles at 120°/Sec Speed
Baseline
17.4 Newton metres
Standard Deviation 4.6
26.0 Newton metres
Standard Deviation 15.5
Peak Torque of Ankle Plantar Flexor Muscles at 120°/Sec Speed
Follow up 1
25.0 Newton metres
Standard Deviation 13.4
40.2 Newton metres
Standard Deviation 12.1
Peak Torque of Ankle Plantar Flexor Muscles at 120°/Sec Speed
Follow up 2
25.0 Newton metres
Standard Deviation 8.6
38.1 Newton metres
Standard Deviation 12.4

SECONDARY outcome

Timeframe: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)

The Biodex isokinetic dynamometer was used for assessment. During isokinetic testing of the subtalar joint, participants were in the seated position, with footwear on. Measurements were taken for the sprained leg, and the mean of five maximal trials was used for analysis.

Outcome measures

Outcome measures
Measure
Proprioceptive Neuromuscular Facilitation (PNF)
n=10 Participants
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Balance
n=10 Participants
Supervised Balance Training
Peak Torque of Foot Evertor Muscles at 30°/Sec Speed
Baseline
11.9 Newton metres
Standard Deviation 1.8
13.6 Newton metres
Standard Deviation 2.5
Peak Torque of Foot Evertor Muscles at 30°/Sec Speed
Follow up 2
13.9 Newton metres
Standard Deviation 4.0
18.8 Newton metres
Standard Deviation 2.3
Peak Torque of Foot Evertor Muscles at 30°/Sec Speed
Follow up 1
13.0 Newton metres
Standard Deviation 3.8
14.5 Newton metres
Standard Deviation 2.0

SECONDARY outcome

Timeframe: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)

The Biodex isokinetic dynamometer was used for assessment. During isokinetic testing of the subtalar joint, participants were in the seated position, with footwear on. Measurements were taken for the sprained leg, and the mean of five maximal trials was used for analysis.

Outcome measures

Outcome measures
Measure
Proprioceptive Neuromuscular Facilitation (PNF)
n=10 Participants
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Balance
n=10 Participants
Supervised Balance Training
Peak Torque of Foot Evertor Muscles at 120°/Sec Speed
Baseline
8.0 Newton metres
Standard Deviation 1.4
9.1 Newton metres
Standard Deviation 1.5
Peak Torque of Foot Evertor Muscles at 120°/Sec Speed
Follow up 1
10.5 Newton metres
Standard Deviation 2.3
8.6 Newton metres
Standard Deviation 2.2
Peak Torque of Foot Evertor Muscles at 120°/Sec Speed
Follow up 2
10.5 Newton metres
Standard Deviation 3.1
13.0 Newton metres
Standard Deviation 3.0

SECONDARY outcome

Timeframe: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)

The Biodex isokinetic dynamometer was used for assessment. During isokinetic testing of the subtalar joint, participants were in the seated position, with footwear on. Measurements were taken for the sprained leg, and the mean of five maximal trials was used for analysis.

Outcome measures

Outcome measures
Measure
Proprioceptive Neuromuscular Facilitation (PNF)
n=10 Participants
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Balance
n=10 Participants
Supervised Balance Training
Peak Torque of Foot Invertor Muscles at 30°/Sec Speed
Baseline
10.1 Newton metres
Standard Deviation 3.2
12.2 Newton metres
Standard Deviation 3.8
Peak Torque of Foot Invertor Muscles at 30°/Sec Speed
Follow up 1
12.6 Newton metres
Standard Deviation 5.6
18.6 Newton metres
Standard Deviation 3.7
Peak Torque of Foot Invertor Muscles at 30°/Sec Speed
Follow up 2
26.2 Newton metres
Standard Deviation 6.5
29.6 Newton metres
Standard Deviation 9.9

SECONDARY outcome

Timeframe: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)

The Biodex isokinetic dynamometer was used for assessment. During isokinetic testing of the subtalar joint, participants were in the seated position, with footwear on. Measurements were taken for the sprained leg, and the mean of five maximal trials was used for analysis.

Outcome measures

Outcome measures
Measure
Proprioceptive Neuromuscular Facilitation (PNF)
n=10 Participants
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Balance
n=10 Participants
Supervised Balance Training
Peak Torque of Foot Invertor Muscles at 120°/Sec Speed
Follow up 2
21.6 Newton metres
Standard Deviation 5.7
27.7 Newton metres
Standard Deviation 8.9
Peak Torque of Foot Invertor Muscles at 120°/Sec Speed
Baseline
6.7 Newton metres
Standard Deviation 2.3
9.3 Newton metres
Standard Deviation 3.5
Peak Torque of Foot Invertor Muscles at 120°/Sec Speed
Follow up 1
9.5 Newton metres
Standard Deviation 3.2
12.0 Newton metres
Standard Deviation 3.7

SECONDARY outcome

Timeframe: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)

Two surface electrodes and a ground electrode were used for assessment. Measurements were taken for the sprained leg, during isokinetic testing of the ankle dorsiflexor muscles, at 30°/sec speed, with the Biodex dynamometer. Normalized values of the electromyographic (EMG) signals were used for analysis, and EMG activity during maximal voluntary isometric contraction of the anterior tibialis muscle was used as the reference value for normalization.

Outcome measures

Outcome measures
Measure
Proprioceptive Neuromuscular Facilitation (PNF)
n=10 Participants
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Balance
n=10 Participants
Supervised Balance Training
Electromyographic Activity of Anterior Tibialis Muscle During Ankle Dorsiflexion at 30°/Sec Speed
Baseline
1.02 Proportion
Standard Deviation 0.25
0.88 Proportion
Standard Deviation 0.10
Electromyographic Activity of Anterior Tibialis Muscle During Ankle Dorsiflexion at 30°/Sec Speed
Follow up 1
0.90 Proportion
Standard Deviation 0.24
1.03 Proportion
Standard Deviation 0.10
Electromyographic Activity of Anterior Tibialis Muscle During Ankle Dorsiflexion at 30°/Sec Speed
Follow up 2
1.02 Proportion
Standard Deviation 0.27
0.92 Proportion
Standard Deviation 0.13

SECONDARY outcome

Timeframe: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)

Two surface electrodes and a ground electrode were used for assessment. Measurements were taken for the sprained leg, during isokinetic testing of the ankle dorsiflexor muscles, at 120°/sec speed, with the Biodex dynamometer. Normalized values of the electromyographic (EMG) signals were used for analysis, and EMG activity during maximal voluntary isometric contraction of the anterior tibialis muscle was used as the reference value for normalization.

Outcome measures

Outcome measures
Measure
Proprioceptive Neuromuscular Facilitation (PNF)
n=10 Participants
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Balance
n=10 Participants
Supervised Balance Training
Electromyographic Activity of Anterior Tibialis Muscle During Ankle Dorsiflexion at 120°/Sec Speed
Follow up 2
1.02 Proportion
Standard Deviation 0.21
0.83 Proportion
Standard Deviation 0.13
Electromyographic Activity of Anterior Tibialis Muscle During Ankle Dorsiflexion at 120°/Sec Speed
Baseline
0.99 Proportion
Standard Deviation 0.13
0.88 Proportion
Standard Deviation 0.23
Electromyographic Activity of Anterior Tibialis Muscle During Ankle Dorsiflexion at 120°/Sec Speed
Follow up 1
0.98 Proportion
Standard Deviation 0.17
0.85 Proportion
Standard Deviation 0.15

SECONDARY outcome

Timeframe: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)

Two surface electrodes and a ground electrode were used for assessment. Measurements were taken for the sprained leg, during isokinetic testing of the ankle plantar flexor muscles, at 30°/sec speed, with the Biodex dynamometer. Normalized values of the electromyographic (EMG) signals were used for analysis, and EMG activity during maximal voluntary isometric contraction of the peroneus longus muscle was used as the reference value for normalization.

Outcome measures

Outcome measures
Measure
Proprioceptive Neuromuscular Facilitation (PNF)
n=10 Participants
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Balance
n=10 Participants
Supervised Balance Training
Electromyographic Activity of Peroneus Longus Muscle During Ankle Plantar Flexion at 30°/Sec Speed
Baseline
0.78 Proportion
Standard Deviation 0.21
0.64 Proportion
Standard Deviation 0.09
Electromyographic Activity of Peroneus Longus Muscle During Ankle Plantar Flexion at 30°/Sec Speed
Follow up 1
0.60 Proportion
Standard Deviation 0.16
0.76 Proportion
Standard Deviation 0.12
Electromyographic Activity of Peroneus Longus Muscle During Ankle Plantar Flexion at 30°/Sec Speed
Follow up 2
0.61 Proportion
Standard Deviation 0.15
0.68 Proportion
Standard Deviation 0.14

SECONDARY outcome

Timeframe: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)

Two surface electrodes and a ground electrode were used for assessment. Measurements were taken for the sprained leg, during isokinetic testing of the ankle plantar flexor muscles, at 120°/sec speed, with the Biodex dynamometer. Normalized values of the electromyographic (EMG) signals were used for analysis, and EMG activity during maximal voluntary isometric contraction of the peroneus longus muscle was used as the reference value for normalization.

Outcome measures

Outcome measures
Measure
Proprioceptive Neuromuscular Facilitation (PNF)
n=10 Participants
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Balance
n=10 Participants
Supervised Balance Training
Electromyographic Activity of Peroneus Longus Muscle During Ankle Plantar Flexion at 120°/Sec Speed
Follow up 2
0.71 Proportion
Standard Deviation 0.16
0.83 Proportion
Standard Deviation 0.12
Electromyographic Activity of Peroneus Longus Muscle During Ankle Plantar Flexion at 120°/Sec Speed
Baseline
0.82 Proportion
Standard Deviation 0.28
0.61 Proportion
Standard Deviation 0.15
Electromyographic Activity of Peroneus Longus Muscle During Ankle Plantar Flexion at 120°/Sec Speed
Follow up 1
0.68 Proportion
Standard Deviation 0.21
0.71 Proportion
Standard Deviation 0.10

SECONDARY outcome

Timeframe: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)

Two surface electrodes and a ground electrode were used for assessment. Measurements were taken for the sprained leg, during isokinetic testing of the foot evertor muscles, at 30°/sec speed, with the Biodex dynamometer. Normalized values of the electromyographic (EMG) signals were used for analysis, and EMG activity during maximal voluntary isometric contraction of the peroneus longus muscle was used as the reference value for normalization.

Outcome measures

Outcome measures
Measure
Proprioceptive Neuromuscular Facilitation (PNF)
n=10 Participants
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Balance
n=10 Participants
Supervised Balance Training
Electromyographic Activity of Peroneus Longus Muscle During Foot Eversion at 30°/Sec Speed
Baseline
0.89 Proportion
Standard Deviation 0.24
0.70 Proportion
Standard Deviation 0.22
Electromyographic Activity of Peroneus Longus Muscle During Foot Eversion at 30°/Sec Speed
Follow up 1
0.78 Proportion
Standard Deviation 0.22
0.68 Proportion
Standard Deviation 0.12
Electromyographic Activity of Peroneus Longus Muscle During Foot Eversion at 30°/Sec Speed
Follow up 2
0.92 Proportion
Standard Deviation 0.17
0.63 Proportion
Standard Deviation 0.16

SECONDARY outcome

Timeframe: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)

Two surface electrodes and a ground electrode were used for assessment. Measurements were taken for the sprained leg, during isokinetic testing of the foot evertor muscles, at 120°/sec speed, with the Biodex dynamometer. Normalized values of the electromyographic (EMG) signals were used for analysis, and EMG activity during maximal voluntary isometric contraction of the peroneus longus muscle was used as the reference value for normalization.

Outcome measures

Outcome measures
Measure
Proprioceptive Neuromuscular Facilitation (PNF)
n=10 Participants
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Balance
n=10 Participants
Supervised Balance Training
Electromyographic Activity of Peroneus Longus Muscle During Foot Eversion at 120°/Sec Speed
Baseline
0.95 Proportion
Standard Deviation 0.34
0.75 Proportion
Standard Deviation 0.15
Electromyographic Activity of Peroneus Longus Muscle During Foot Eversion at 120°/Sec Speed
Follow up 1
0.67 Proportion
Standard Deviation 0.26
0.70 Proportion
Standard Deviation 0.15
Electromyographic Activity of Peroneus Longus Muscle During Foot Eversion at 120°/Sec Speed
Follow up 2
0.87 Proportion
Standard Deviation 0.43
0.74 Proportion
Standard Deviation 0.16

SECONDARY outcome

Timeframe: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)

Two surface electrodes and a ground electrode were used for assessment. Measurements were taken for the sprained leg, during isokinetic testing of the foot invertor muscles, at 30°/sec speed, with the Biodex dynamometer. Normalized values of the electromyographic (EMG) signals were used for analysis, and EMG activity during maximal voluntary isometric contraction of the anterior tibialis muscle was used as the reference value for normalization.

Outcome measures

Outcome measures
Measure
Proprioceptive Neuromuscular Facilitation (PNF)
n=10 Participants
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Balance
n=10 Participants
Supervised Balance Training
Electromyographic Activity of Tibialis Anterior Muscle During Foot Inversion at 30°/Sec Speed
Baseline
0.40 Proportion
Standard Deviation 0.11
0.39 Proportion
Standard Deviation 0.10
Electromyographic Activity of Tibialis Anterior Muscle During Foot Inversion at 30°/Sec Speed
Follow up 1
0.32 Proportion
Standard Deviation 0.13
0.40 Proportion
Standard Deviation 0.18
Electromyographic Activity of Tibialis Anterior Muscle During Foot Inversion at 30°/Sec Speed
Follow up 2
0.54 Proportion
Standard Deviation 0.16
0.31 Proportion
Standard Deviation 0.15

SECONDARY outcome

Timeframe: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)

Two surface electrodes and a ground electrode were used for assessment. Measurements were taken for the sprained leg, during isokinetic testing of the foot invertor muscles, at 120°/sec speed, with the Biodex dynamometer. Normalized values of the electromyographic (EMG) signals were used for analysis, and EMG activity during maximal voluntary isometric contraction of the anterior tibialis muscle was used as the reference value for normalization.

Outcome measures

Outcome measures
Measure
Proprioceptive Neuromuscular Facilitation (PNF)
n=10 Participants
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Balance
n=10 Participants
Supervised Balance Training
Electromyographic Activity of Tibialis Anterior Muscle During Foot Inversion at 120°/Sec Speed
Baseline
0.43 Proportion
Standard Deviation 0.12
0.44 Proportion
Standard Deviation 0.15
Electromyographic Activity of Tibialis Anterior Muscle During Foot Inversion at 120°/Sec Speed
Follow up 1
0.45 Proportion
Standard Deviation 0.16
0.36 Proportion
Standard Deviation 0.14
Electromyographic Activity of Tibialis Anterior Muscle During Foot Inversion at 120°/Sec Speed
Follow up 2
0.38 Proportion
Standard Deviation 0.14
0.32 Proportion
Standard Deviation 0.17

SECONDARY outcome

Timeframe: Twelve months after the completion of training

Outcome measures

Outcome measures
Measure
Proprioceptive Neuromuscular Facilitation (PNF)
n=10 Participants
Supervised Proprioceptive Neuromuscular Facilitation (PNF) Training
Balance
n=10 Participants
Supervised Balance Training
Participants With Recurrent Ankle Sprain
2 Participants
0 Participants

Adverse Events

Proprioceptive Neuromuscular Facilitation (PNF)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Balance

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lazaros Lazarou

Aristotle University of Thessaloniki

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place