- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05090423
The Effect of Additional Neurodynamic Intervention in Patients With Chronic Ankle Instability
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Taipei, Taiwan, 11221
- National Yang Ming University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental: balance training alone
The subjects will receive 12 sessions of balance training over six to eight weeks.
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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. |
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Experimental: Experimental: balance training and neurodynamic intervention for the common peroneal nerve
The subjects will receive the 12 sessions of balance training and neurodynamic intervention for the common peroneal nerve over six to eight weeks.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pressure Pain Threshold- Anterior Talofibular Ligament
Time Frame: Within one week after 12 treatment sessions
|
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.
|
Within one week after 12 treatment sessions
|
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Pressure Pain Threshold- Calcaneofibular Ligament
Time Frame: Within one week after 12 treatment sessions
|
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.
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Within one week after 12 treatment sessions
|
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Active Knee Extension Range of Motion During Slump Test in Ankle Plantar Flexion With Inversion
Time Frame: Within one week after 12 treatment session
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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.
|
Within one week after 12 treatment session
|
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Pressure Pain Threshold- Peroneal Brevis Muscle
Time Frame: Within one week after 12 treatment sessions
|
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.
|
Within one week after 12 treatment sessions
|
|
Pressure Pain Threshold- Peroneal Longus Muscle
Time Frame: Within one week after 12 treatment sessions
|
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.
|
Within one week after 12 treatment sessions
|
|
Pressure Pain Threshold- Common Peroneal Nerve
Time Frame: Within one week after 12 treatment sessions
|
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.
|
Within one week after 12 treatment sessions
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Y Balance Test- Anterior Direction
Time Frame: Within one week after 12 treatment sessions
|
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.
|
Within one week after 12 treatment sessions
|
|
The Foot and Ankle Ability Measures- Sports
Time Frame: Within one week after 12 treatment sessions
|
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. |
Within one week after 12 treatment sessions
|
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The Foot and Ankle Ability Measures- Activity of Life
Time Frame: Within one week after 12 treatment sessions
|
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. |
Within one week after 12 treatment sessions
|
|
Weight Bearing Lunge Test
Time Frame: Within one week after 12 treatment sessions
|
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. |
Within one week after 12 treatment sessions
|
|
Hamstring Flexibility
Time Frame: Within one week after 12 treatment sessions
|
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. |
Within one week after 12 treatment sessions
|
|
The Foot and Ankle Ability Measures- Activity of Life (Self- Awareness Score)
Time Frame: Within one week after 12 treatment sessions
|
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.
|
Within one week after 12 treatment sessions
|
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The Foot and Ankle Ability Measures- Sports (Self- Awareness Score)
Time Frame: Within one week after 12 treatment sessions
|
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.
|
Within one week after 12 treatment sessions
|
|
Y Balance- Posterolateral Direction
Time Frame: Within one week after 12 treatment sessions
|
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.
|
Within one week after 12 treatment sessions
|
|
Y Balance- Posteromedial Direction
Time Frame: Within one week after 12 treatment sessions
|
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.
|
Within one week after 12 treatment sessions
|
Collaborators and Investigators
Investigators
- Study Director: Shih Yi-Fen, Ph.D, Department of Physical Therapy and Assistive Technology, National Yang-Ming
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YM110112F
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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