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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT01853462
Date of registration:	09/05/2013
Prospective Registration:	Yes
Primary sponsor:	Lazaros Lazarou
Public title:	Effects of Two Supervised Training Programs for the Rehabilitation of Ankle Sprains
Scientific title:	Effects of Supervised Balance and Proprioceptive Neuromuscular Facilitation Training After Lateral Ligament Sprains of the Ankle
Date of first enrolment:	December 2014
Target sample size:	22
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT01853462
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
Phase:	N/A

Countries of recruitment
Greece

Contacts

Name:	Lazaros S Lazarou, BSc, MSc
Address:
Telephone:
Email:
Affiliation:	AristotleUniversity

Key inclusion & exclusion criteria

Inclusion Criteria:

- Individuals with a symptomatic, conventionally treated, post acute (after 14 days)
lateral ankle sprain, Grade I-II

Exclusion Criteria:

- 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

Age minimum: 18 Years
Age maximum: 40 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ankle Sprains

Intervention(s)

Other: Balance training

Other: PNF training

Primary Outcome(s)

Ankle Functional Stability, Via the Single-leg Hop for Distance Test [Time Frame: 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 [Time Frame: 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 [Time Frame: 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 [Time Frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)]

Secondary Outcome(s)

Ankle Dorsiflexion Range of Motion [Time Frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)]

Electromyographic Activity of Peroneus Longus Muscle During Ankle Plantar Flexion at 120°/Sec Speed [Time Frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)]

Pain Intensity During the Week Before Testing [Time Frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)]

Peak Torque of Foot Evertor Muscles at 30°/Sec Speed [Time Frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)]

Ankle Joint Sense for 10° Dorsiflexion [Time Frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)]

Ankle Joint Sense for 30° Plantar Flexion [Time Frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)]

Electromyographic Activity of Peroneus Longus Muscle During Foot Eversion at 120°/Sec Speed [Time Frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)]

Electromyographic Activity of Anterior Tibialis Muscle During Ankle Dorsiflexion at 30°/Sec Speed [Time Frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)]

Electromyographic Activity of Peroneus Longus Muscle During Ankle Plantar Flexion at 30°/Sec Speed [Time Frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)]

Present Pain [Time Frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)]

Electromyographic Activity of Peroneus Longus Muscle During Foot Eversion at 30°/Sec Speed [Time Frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)]

Peak Torque of Foot Invertor Muscles at 120°/Sec Speed [Time Frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)]

Anterior-posterior Stability Index [Time Frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)]

Electromyographic Activity of Tibialis Anterior Muscle During Foot Inversion at 120°/Sec Speed [Time Frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)]

Peak Torque of Ankle Dorsiflexor Muscles at 120°/Sec Speed [Time Frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)]

Medial-lateral Stability Index [Time Frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)]

Overall Stability Index [Time Frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)]

Pain Sensation [Time Frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)]

Peak Torque of Ankle Dorsiflexor Muscles at 30°/Sec Speed [Time Frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)]

Peak Torque of Foot Evertor Muscles at 120°/Sec Speed [Time Frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)]

Participants With Recurrent Ankle Sprain [Time Frame: Twelve months after the completion of training]

Peak Torque of Foot Invertor Muscles at 30°/Sec Speed [Time Frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)]

Ankle Joint Sense for 15° Plantar Flexion [Time Frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)]

Electromyographic Activity of Anterior Tibialis Muscle During Ankle Dorsiflexion at 120°/Sec Speed [Time Frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)]

Electromyographic Activity of Tibialis Anterior Muscle During Foot Inversion at 30°/Sec Speed [Time Frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)]

Peak Torque of Ankle Plantar Flexor Muscles at 120°/Sec Speed [Time Frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)]

Peak Torque of Ankle Plantar Flexor Muscles at 30°/Sec Speed [Time Frame: Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)]

Secondary ID(s)

PNF-123-BAL-SPR

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	01/11/2018
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT01853462

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