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Ankle SprainsNCT05090423

The Effect of Additional Neurodynamic Intervention in Patients With Chronic Ankle Instability

A study testing balance training alone and balance training and neurodynamic intervention for the common peroneal nerve in people with Ankle Sprains, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Approximately 40% of acute ankle sprain would develop into chronic ankle instability (CAI). Chronic ankle instability is characterized by pain, repeated sprains and giving way. Recently, the pathomechanical impairment, sensory-perceptual impairment and motor-behavioral impairment have been documented in the chronic… Read more about this study

Who is it for?
Ages 20 to 50 years
Conditions the study is for
Ankle Sprains
What is being tested?
balance training alone and balance training and neurodynamic intervention for the common peroneal nerve
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteTaiwan
Study dates
5 Jan 2022to 30 Jun 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • History of at least two ankle sprains in the same leg, of which the first sprain is more than one year
  • Leading to at least one interrupted day of desired physical activity
  • The Cumberland Ankle Instability Tool (CAIT) ≦ 24
  • Slump test in ankle plantar flexion with inversion: positive

Who cannot join

  • Pregnancy
  • Surgical treatments
  • Previous fractures in either lower extremity
  • Any concomitant lower extremity pathology, for example, vascular disease, osteoarthritis and rheumatoid arthritis
  • Significant pain or injury to the lumbar or cervical spine
  • Regular use of medication: anti-inflammatory drugs, painkiller, steroid or muscle relaxants
  • Previous manual therapy or exercise interventions received on the lower extremity within the previous 3 months

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • National Yang Ming University

    Taipei, 11221

Other trials in Taiwan

About this study

Approximately 40% of acute ankle sprain would develop into chronic ankle instability (CAI). Chronic ankle instability is characterized by pain, repeated sprains and giving way. Recently, the pathomechanical impairment, sensory-perceptual impairment and motor-behavioral impairment have been documented in the chronic ankle instability model. Previous research revealed that compared to the control subjects, people with CAI had lower pressure pain threshold (PPT). This increased mechanosensitivity of the neural tissues around the ankle might account for pain and dysfunction in people with CAI. Also, the other study indicated that in subjects following ankle inversion sprain there is greater restriction of knee extension on the injured side compared to non-injured side in the slump test with the ankle plantar flexion and inversion, which may suggest the restriction in mobility of the common peroneal tract. However, the effects of neurodynamic intervention, which addresses the mechanosensitivity problems, in people with CAI are still unclear.

Therefore, the aim of the study is to investigate the effect of additional neurodynamic intervention on the ankle range of motion, mechanosensitivity, balance performance and self-reported function.

Read the detailed description

Chronic ankle instability (CAI) is characterized by pain, repeated sprains and giving way. Approximately 40% of acute ankle sprain would develop into chronic ankle instability. Recently, the pathomechanical impairment, sensory-perceptual impairment and motor-behavioral impairment have been documented in the chronic ankle instability model. Previous research revealed that compared to the control subjects, people with CAI had lower pressure pain threshold (PPT). This increased mechanosensitivity of the neural tissues around the ankle might account for pain and dysfunction in people with CAI. Pahor et al., indicated that in subjects following ankle inversion sprain there is greater restriction of knee extension on the injured side compared to non-injured side in the slump test with the ankle plantar flexion and inversion, which may suggest the restriction in mobility of the common peroneal tract. However, the effects of neurodynamic intervention, which addresses the mechanosensitivity problems, in people with CAI are still unclear. Purpose: The aim of the study is to investigate the effects of neurodynamic intervention on the mechanosensitivity, balance performance and self-reported function in patients with CAI. Study design: A randomized controlled trial design. Single-blinded. Methods: Forty subjects between 20-50 with CAI were recruited and randomized into either the exercise only group or the neurodynamic intervention with exercise (neurodynamic) group. The sample size was calculated based on the PPT data of Lorenzo-Sanchez-Aguilera et al's, which requires 20 subjects in each group to reach a statistical power of 0.8. Both groups were receive 12 interventions within 6-8 weeks. The exercise only group performed balance training, while the neurodynamic group received balance training and neurodynamic intervention for the common peroneal nerve. Outcome measures included demographic data, pressure pain threshold, active knee extension range of motion (ROM) of the slump test with ankle plantarflexion and inversion (AKEOST), hamstrings flexibility, ankle range of motion, Y balance test and foot and ankle ability measure (FAAM).

Conditions
Ankle Sprains
Being tested
balance training alone, balance training and neurodynamic intervention for the common peroneal nerve
Keywords
Chronic ankle instability, Neurodynamics, Mechanosensitivity
Medical subject headings
Ankle Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • balance training aloneOther

    The subjects will warm up to stretch the lower extremity for 5 minutes.

    The physical therapist will instruct the patient how to use the foot tripod within 5 minutes. And then, giving him or her balance training.

    At the first, the patient double legs stand on the ground to throw and catch a ball for 30 seconds, and then one leg stand on the ground to throw and catch a ball for 30 seconds. When finished, the patient can take 1 minutes rest.

    Second, the patient will finish the prescribed the task stand on different materials, which included the exercise mat, dynair, bosu and foam roller.

  • balance training and neurodynamic intervention for the common peroneal nerveOther

    The physical therapist will give the patient neurodynamic intervention for the common peroneal nerve, which is performed slider the nerve 2 seconds.

    The slider technique is repeated 30 seconds for 4 times, each time can be take a rest 1 minutes.

    The physical therapist will instruct the patient how to use the foot tripod within 5 minutes. And then, giving him or her balance training.

    At the first, the patient double legs stand on the ground to throw and catch a ball for 30 seconds, and then one leg stand on the ground to throw and catch a ball for 30 seconds. When finished, the patient can take 1 minutes rest.

    Second, the patient will finish the prescribed the task stand on different materials, which included the exercise mat, dynair, bosu and foam roller.

Study groups in NCT05090423
Study groupRoleWhat they receive
Experimental: balance training aloneExperimentalThe subjects will receive 12 sessions of balance training over six to eight weeks.
Receives: Other: balance training alone
Experimental: balance training and neurodynamic intervention for the common peroneal nerveExperimentalThe subjects will receive the 12 sessions of balance training and neurodynamic intervention for the common peroneal nerve over six to eight weeks.
Receives: Other: balance training and neurodynamic intervention for the common peroneal nerve

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pressure Pain Threshold- Anterior Talofibular Ligament

    Using the PainTestTM FDX algometer, apply vertical contact and average force to measure pressure pain thresholds at the anterior talofibular ligament. The point is tested three times with a 30-second interval between tests, and the average of the three measurements is recorded.

    Measured: Within one week after 12 treatment sessions

  2. Pressure Pain Threshold- Calcaneofibular Ligament

    Using the PainTestTM FDX algometer, apply vertical contact and average force to measure pressure pain thresholds at the calcaneofibular ligament. The point is tested three times with a 30-second interval between tests, and the average of the three measurements is recorded.

    Measured: Within one week after 12 treatment sessions

  3. Active Knee Extension Range of Motion During Slump Test in Ankle Plantar Flexion With Inversion

    The subjects sat on the edge of the bed without touching the ground with their feet. The physical therapist assisted the subjects in maintaining a neutral pelvis position. First, the subjects were asked to flex the neck, trunk, and finally the lumbar to tighten the back. Second, while the subjects plantarflexed and inverted the ankle, they performed the knee extension movement, and the angle of knee motion was recorded. Participants performed three practice trials followed by three test trials and averaged the three tests.

    Measured: Within one week after 12 treatment session

  4. Pressure Pain Threshold- Peroneal Brevis Muscle

    Using the PainTestTM FDX algometer, apply vertical contact and average force to measure pressure pain thresholds at the peroneal brevis muscle. The point is tested three times with a 30-second interval between tests, and the average of the three measurements is recorded.

    Measured: Within one week after 12 treatment sessions

  5. Pressure Pain Threshold- Peroneal Longus Muscle

    Using the PainTestTM FDX algometer, apply vertical contact and average force to measure pressure pain thresholds at the peroneal longus muscle. The point is tested three times with a 30-second interval between tests, and the average of the three measurements is recorded.

    Measured: Within one week after 12 treatment sessions

  6. Pressure Pain Threshold- Common Peroneal Nerve

    Using the PainTestTM FDX algometer, apply vertical contact and average force to measure pressure pain thresholds at the common peroneal nerve. The point is tested three times with a 30-second interval between tests, and the average of the three measurements is recorded.

    Measured: Within one week after 12 treatment sessions

Secondary outcomes (9)
  1. Y Balance Test- Anterior Direction

    Participants stood on the Y-Balance Test device and reached with the non-stance leg in the anterior, posterolateral, and posteromedial directions, starting with the dominant leg, in sequence. Each participant performed six practice trials to become familiar with the procedure. For data collection, three final trials in each direction were recorded. Leg length was measured from the anterior superior iliac spine to the distal tip of the medial malleolus. Reach distance in centimeters was normalized to leg length by dividing the reach distance by leg length and multiplying by 100 to obtain the percentage of leg length for statistical analysis.

    Measured: Within one week after 12 treatment sessions

  2. The Foot and Ankle Ability Measures- Sports

    The Foot and Ankle Ability Measure (FAAM) Sports Subscale is a self-reported questionnaire consisting of 8 items that assess the participant's perceived ability to perform sports-related activities. Each item is rated on a 5-point scale (0 = unable to do, 1 = extreme difficulty, 2 = moderate difficulty, 3 = slight difficulty, 4 = no difficulty). If an item is not applicable, the participant marks "N/A."

    Raw scores are summed and converted to a percentage score using the following formula: (raw score ÷ maximum possible score) × 100, with higher scores indicating better functional ability.

    Measured: Within one week after 12 treatment sessions

  3. The Foot and Ankle Ability Measures- Activity of Life

    The Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) subscale is a self-reported questionnaire consisting of 21 items that assess the participant's perceived difficulty in performing activities of daily living. Each item is rated on a 5-point scale (0 = unable to do, 1 = extreme difficulty, 2 = moderate difficulty, 3 = slight difficulty, 4 = no difficulty). If an item is not applicable, the participant marks "N/A."

    Raw scores are summed and converted to a percentage score using the following formula: (raw score ÷ maximum possible score) × 100, with higher scores indicating better functional ability.

    Measured: Within one week after 12 treatment sessions

  4. Weight Bearing Lunge Test

    Asked the person to face the wall and placed the tested foot in front, with the second toe and heel in a line perpendicular to the wall. The contralateral limb was positioned behind the testing limb in a comfortable position, and hands were placed on the wall in front to maintain stability. The gravity inclinometer was placed at the tibial tuberosity to measure the angle. The subjects lunged forward, trying to touch a vertical line on the wall with their knee, while keeping their heel in contact with the ground.

    Participants performed three practice trials followed by three test trials and averaged the three tests.

    Measured: Within one week after 12 treatment sessions

  5. Hamstring Flexibility

    Measured hamstring flexibility using the 90-90 passive knee extension test. The subject lay flat on their back on the bed and straps were used to secure the pelvis. The test leg was positioned with the hip and knee at 90 degrees, while the other leg remained straight on the bed. The subject's knee was then passively extended. The goniometer's stationary arm was attached to the middle of the thigh, the axis was aligned with the lateral epicondyle of the femur, and the moving arm was positioned to the lateral malleolus. The knee extension angle was measured. The value recorded was the angle between the lower leg and the vertical line.

    Participants performed three practice trials followed by three test trials and averaged the three tests.

    Measured: Within one week after 12 treatment sessions

  6. The Foot and Ankle Ability Measures- Activity of Life (Self- Awareness Score)

    The Activities of Daily Living (self-awareness score) is a self-reported measure in which the participant rates the functional status of the involved (patient) foot relative to the uninvolved (healthy) foot. The uninvolved foot is assigned a reference value of 100 points. The participant then rates the involved foot on a scale ranging from 0 to 100, with higher scores indicating better self-perceived functional ability in daily life.

    Measured: Within one week after 12 treatment sessions

  7. The Foot and Ankle Ability Measures- Sports (Self- Awareness Score)

    The Sports (self-awareness score) is a self-reported measure in which the participant rates the perceived functional ability of the involved (patient) foot during sports-related activities relative to the uninvolved (healthy) foot. The uninvolved foot is assigned a reference value of 100 points. The participant then rates the involved foot on a scale ranging from 0 to 100, with higher scores indicating better self-perceived sports-related functional ability.

    Measured: Within one week after 12 treatment sessions

  8. Y Balance- Posterolateral Direction

    Participants stood on the Y-Balance Test device and reached with the non-stance leg in the anterior, posterolateral, and posteromedial directions, starting with the dominant leg, in sequence. Each participant performed six practice trials to become familiar with the procedure. For data collection, three final trials in each direction were recorded. Leg length was measured from the anterior superior iliac spine to the distal tip of the medial malleolus. Reach distance in centimeters was normalized to leg length by dividing the reach distance by leg length and multiplying by 100 to obtain the percentage of leg length for statistical analysis.

    Measured: Within one week after 12 treatment sessions

  9. Y Balance- Posteromedial Direction

    Participants stood on the Y-Balance Test device and reached with the non-stance leg in the anterior, posterolateral, and posteromedial directions, starting with the dominant leg, in sequence. Each participant performed six practice trials to become familiar with the procedure. For data collection, three final trials in each direction were recorded. Leg length was measured from the anterior superior iliac spine to the distal tip of the medial malleolus. Reach distance in centimeters was normalized to leg length by dividing the reach distance by leg length and multiplying by 100 to obtain the percentage of leg length for statistical analysis.

    Measured: Within one week after 12 treatment sessions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2021
  2. Study start5 Jan 2022
  3. Primary completion30 Jun 2024
  4. Study completion30 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05090423
Sponsor's protocol ID
YM110112F
Status last verified
Dec 2025
First submitted
27 Sep 2021
Last updated
15 Jan 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing balance training alone and balance training and neurodynamic intervention for the common peroneal nerve in people with Ankle Sprains, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pressure Pain Threshold- Anterior Talofibular Ligament (time frame: Within one week after 12 treatment sessions). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.

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