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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05090423

Enrollment

Registered

2021-10-22

Start date

2022-01-05

Completion date

2024-06-30

Last updated

2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Sprains

Keywords

Chronic ankle instability, Neurodynamics, Mechanosensitivity

Brief 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 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.

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).

Interventions

OTHERbalance training alone

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.

OTHERbalance training and neurodynamic intervention for the common peroneal nerve

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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to 50 Years

Healthy volunteers

Inclusion criteria

1. History of at least two ankle sprains in the same leg, of which the first sprain is more than one year 2. Leading to at least one interrupted day of desired physical activity 3. The Cumberland Ankle Instability Tool (CAIT) ≦ 24 4. Slump test in ankle plantar flexion with inversion: positive

Exclusion criteria

1. Pregnancy 2. Surgical treatments 3. Previous fractures in either lower extremity 4. Any concomitant lower extremity pathology, for example, vascular disease, osteoarthritis and rheumatoid arthritis 5. Significant pain or injury to the lumbar or cervical spine 6. Regular use of medication: anti-inflammatory drugs, painkiller, steroid or muscle relaxants 7. Previous manual therapy or exercise interventions received on the lower extremity within the previous 3 months

Design outcomes

Primary

Measure	Time frame	Description
Pressure Pain Threshold- Anterior Talofibular Ligament	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.
Pressure Pain Threshold- Calcaneofibular Ligament	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.
Active Knee Extension Range of Motion During Slump Test in Ankle Plantar Flexion With Inversion	Within one week after 12 treatment session	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.
Pressure Pain Threshold- Peroneal Brevis Muscle	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.
Pressure Pain Threshold- Peroneal Longus Muscle	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.
Pressure Pain Threshold- Common Peroneal Nerve	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.

Secondary

Measure	Time frame	Description
The Foot and Ankle Ability Measures- Sports (Self- Awareness Score)	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.
Y Balance Test- Anterior Direction	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.
Y Balance- Posteromedial Direction	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.
Y Balance- Posterolateral Direction	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.
The Foot and Ankle Ability Measures- Sports	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.
The Foot and Ankle Ability Measures- Activity of Life	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.
Weight Bearing Lunge Test	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.
Hamstring Flexibility	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.
The Foot and Ankle Ability Measures- Activity of Life (Self- Awareness Score)	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.

Countries

Taiwan

Participant flow

Recruitment details

In this study, participants with chronic ankle instability were recruited from Yang Ming Chiao Tung University and various orthopedic and rehabilitation clinics in Taipei. Potential participants were first contacted to confirm preliminary eligibility. During the initial meeting, the study process and relevant details were explained. Eligibility was further verified based on inclusion and exclusion criteria. Upon confirmation, participants provided informed consent to participate in the study.

Pre-assignment details

In this study, 59 participants were initially recruited to meet the inclusion criteria. Among them, 36 participants (14 males and 22 females) were confirmed to meet the eligibility requirements. Due to others not meeting inclusion criteria or falling under exclusion criteria.

Participants by arm

Arm	Count
Exercise Group The exercise group receives 12 treatment interventions over six to eight weeks, with each session lasting approximately 20 minutes. First, 5-minute warm-up and stretching session, followed by foot core exercises and instruction on foot stability movements. The 12 treatment sessions were divided into three stages based on difficulty.	18
Neurodynamic Group The exercise group underwent 12 treatment sessions over a period of six to eight weeks, each lasting about 20 minutes. Initially, the treatment involved peroneal nerve sliding techniques: movements were executed every two seconds for 30 seconds, repeated four times. Between each session, there was a one-minute rest, totaling five minutes. The 12 sessions of neurodynamic interventions were categorized into three progressive stages. Following this, participants engaged in foot core exercises and received instructions on foot stability movements, also organized into three stages based on difficulty.	18
Total	36

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Because of the covid-19	3	2
Overall Study	repeated ankle sprain in daily of life	0	1

Baseline characteristics

Characteristic	Neurodynamic Group	Total	Exercise Group
Active knee extension range of motion during slump test in ankle plantar flexion with inversion	36.39 degree STANDARD_DEVIATION 3.39	35.29 degree STANDARD_DEVIATION 14.22	34.19 degree STANDARD_DEVIATION 3.39
Age, Continuous	25 years STANDARD_DEVIATION 4.62	24.64 years STANDARD_DEVIATION 4.7	24 years STANDARD_DEVIATION 4.84
Foot and ankle ability measure-Activity of Life	91.6 % STANDARD_DEVIATION 7.81	92.29 % STANDARD_DEVIATION 7.47	92.99 % STANDARD_DEVIATION 7.19
Foot and ankle ability measure- Activity of Life (Self- Awareness Score)	82.5 units on a scale STANDARD_DEVIATION 15.46	83.53 units on a scale STANDARD_DEVIATION 12.05	84.56 units on a scale STANDARD_DEVIATION 7.59
Foot and ankle ability measure-sports	81.94 % STANDARD_DEVIATION 14.57	81.54 % STANDARD_DEVIATION 13.81	81.15 % STANDARD_DEVIATION 13.52
Foot and ankle ability measure- Sports (Self- Awareness Score)	72.39 units on a scale STANDARD_DEVIATION 20	73.97 units on a scale STANDARD_DEVIATION 16.28	75.56 units on a scale STANDARD_DEVIATION 11.87
Hamstring flexibility	41.02 degree STANDARD_DEVIATION 2.61	40.83 degree STANDARD_DEVIATION 10.93	40.63 degree STANDARD_DEVIATION 2.61
Pressure pain threshold-anterior talofibular ligament	3.38 kg/ cm² STANDARD_DEVIATION 0.85	3.5 kg/ cm² STANDARD_DEVIATION 1.09	3.6 kg/ cm² STANDARD_DEVIATION 1.29
Pressure pain threshold-calcaneofibular ligament	4.14 kg/ cm² STANDARD_DEVIATION 0.1	4.43 kg/ cm² STANDARD_DEVIATION 1.22	4.72 kg/ cm² STANDARD_DEVIATION 1.37
Pressure pain threshold-common peroneal nerve	4.21 kg/ cm² STANDARD_DEVIATION 1.34	4.74 kg/ cm² STANDARD_DEVIATION 1.5	5.28 kg/ cm² STANDARD_DEVIATION 1.49
Pressure pain threshold-peroneal brevis muscle	3.73 kg/ cm² STANDARD_DEVIATION 1.16	4.11 kg/ cm² STANDARD_DEVIATION 1.33	4.48 kg/ cm² STANDARD_DEVIATION 1.41
Pressure pain threshold-peroneal longus muscle	5.27 kg/ cm² STANDARD_DEVIATION 1.35	5.83 kg/ cm² STANDARD_DEVIATION 1.56	6.39 kg/ cm² STANDARD_DEVIATION 1.59
Race and Ethnicity Not Collected	—	0 Participants	—
Region of Enrollment Taiwan	18 participants	36 participants	18 participants
Sex: Female, Male Female	11 Participants	22 Participants	11 Participants
Sex: Female, Male Male	7 Participants	14 Participants	7 Participants
Weight-bearing lunge test	43.96 degree STANDARD_DEVIATION 5.36	44.42 degree STANDARD_DEVIATION 6.66	44.87 degree STANDARD_DEVIATION 7.89
Y balance test-anterior direction	53.05 % STANDARD_DEVIATION 5.79	54.09 % STANDARD_DEVIATION 5.51	55.1 % STANDARD_DEVIATION 5.28
Y balance test-posterolateral direction	88.27 % STANDARD_DEVIATION 10.75	91.22 % STANDARD_DEVIATION 10.2	94.2 % STANDARD_DEVIATION 8.86
Y balance test-posteromedial direction	84.3 % STANDARD_DEVIATION 9.67	84.71 % STANDARD_DEVIATION 8.7	85.09 % STANDARD_DEVIATION 7.94

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 18	0 / 18
other Total, other adverse events	0 / 18	0 / 18
serious Total, serious adverse events	0 / 18	0 / 18

Outcome results

Primary

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.

Time frame: Within one week after 12 treatment session

Arm	Measure	Value (MEAN)	Dispersion
Exercise Group	Active Knee Extension Range of Motion During Slump Test in Ankle Plantar Flexion With Inversion	24.53 degree	Standard Deviation 1.9
Neurodynamic Group	Active Knee Extension Range of Motion During Slump Test in Ankle Plantar Flexion With Inversion	17.8 degree	Standard Deviation 1.9

p-value: 0.018ANOVA

Primary

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.