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

Primary Purpose

Ankle Sprains

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
balance training alone
balance training and neurodynamic intervention for the common peroneal nerve
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Sprains focused on measuring Chronic ankle instability, Neurodynamics, Mechanosensitivity

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • National Yang Ming UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Experimental: balance training alone

Experimental: balance training and neurodynamic intervention for the common peroneal nerve

Arm Description

The subjects will receive the balance training twice a week for 6 weeks.

The subjects will receive the balance training and neurodynamic intervention for the common peroneal nerve twice a week for 6 weeks.

Outcomes

Primary Outcome Measures

Ankle range of motion
Ask the person to face the wall and the tested foot in front, then the second toe and heel in the line is perpendicular to the wall. The contralateral limb is positioned behind the testing limb in a comfortable position and hands are placed on the wall in front to maintain stability. The gravity inclinometer is placed at the tibial tuberosity to measure the angle. The subjects will lunge forward trying to touch a vertical line on the wall with their knee, at the same time keeping heel contact with ground. Participants will perform three practice trials followed by 3 test trials and average the 3 tests.
Ankle range of motion
Ask the person to face the wall and the tested foot in front, then the second toe and heel in the line is perpendicular to the wall. The contralateral limb is positioned behind the testing limb in a comfortable position and hands are placed on the wall in front to maintain stability. The gravity inclinometer is placed at the tibial tuberosity to measure the angle. The subjects will lunge forward trying to touch a vertical line on the wall with their knee, at the same time keeping heel contact with ground. Participants will perform three practice trials followed by 3 test trials and average the 3 tests.
Mechanosensitivity: Pain pressure threshold
Using the plastic universal goniometer to measure the pain pressure threshold (PPT) of the anterior talofibular ligament, calcaneofibular ligament, peroneal nerve, peroneal longus muscle and peroneal brevis muscle. Measure a total of three times, and take a 30 seconds rest interval each time. In the end, the investigators will take average of the 3 tests.
Mechanosensitivity: Pain pressure threshold
Using the plastic universal goniometer to measure the pain pressure threshold (PPT) of the anterior talofibular ligament, calcaneofibular ligament, peroneal nerve, peroneal longus muscle and peroneal brevis muscle. Measure a total of three times, and take a 30 seconds rest interval each time. In the end, the investigators will take average of the 3 tests.
Mechanosensitivity: Slump test with ankle plantar flexion and inversion to measure active knee range of motion
The subjects sit on the edge of the bed without touching ground with their feet. The physical therapist assists the subjects to maintain the neutral pelvis position. First, ask the subjects flex the neck, trunk, and finally flex the lumbar to tighten the back. Second, while the subjects plantar and invert the ankle, participants will do the knee extension movement and record the angle of knee motion. Participants will perform three practice trials followed by 3 test trials and average the 3 tests.
Mechanosensitivity: Slump test with ankle plantar flexion and inversion to measure active knee range of motion
The subjects sit on the edge of the bed without touching ground with their feet. The physical therapist assists the subjects to maintain the neutral pelvis position. First, ask the subjects flex the neck, trunk, and finally flex the lumbar to tighten the back. Second, while the subjects plantar and invert the ankle, participants will do the knee extension movement and record the angle of knee motion. Participants will perform three practice trials followed by 3 test trials and average the 3 tests.
Balance performance
The subjects will stand on Y-balance kit and reach their legs alternatively to anterior, posterolateral and posteromedial direction with dominant leg first, in sequence. The subjects will practice 6 times first to familiarize the test procedure, then the final three measurements were collected and normalized with subject's lower limb length for statistical analysis.
Balance performance
The subjects will stand on Y-balance kit and reach their legs alternatively to anterior, posterolateral and posteromedial direction with dominant leg first, in sequence. The subjects will practice 6 times first to familiarize the test procedure, then the final three measurements were collected and normalized with subject's lower limb length for statistical analysis.
Self-reported function: The Foot and Ankle Ability Measures (FAAM)
The Foot and Ankle Ability Measures (FAAM) is a self-report measure that evaluate physical function of lower extremities musculoskeletal disorders. The measurement includes two parts, activities of daily living subscale of 21 items and sports subscale of 8 items. For each question, the subjects will chose the appropriate answer that most clearly describes their condition within the past week. It is based on the 4-0 scale. (4: no difficulty, 3: slight difficulty, 2: moderate difficulty, 1: extreme difficulty, 0: unable to do) If an activity in question is limited by something other than their foot or ankle, the patient is asked to record N/A. The sum of the scores in the two parts is less than ninety points, indicating that there is ankle instability
Self-reported function: The Foot and Ankle Ability Measures (FAAM)
The Foot and Ankle Ability Measures (FAAM) is a self-report measure that evaluate physical function of lower extremities musculoskeletal disorders. The measurement includes two parts, activities of daily living subscale of 21 items and sports subscale of 8 items. For each question, the subjects will chose the appropriate answer that most clearly describes their condition within the past week. It is based on the 4-0 scale. (4: no difficulty, 3: slight difficulty, 2: moderate difficulty, 1: extreme difficulty, 0: unable to do) If an activity in question is limited by something other than their foot or ankle, the patient is asked to record N/A. The sum of the scores in the two parts is less than ninety points, indicating that there is ankle instability

Secondary Outcome Measures

Full Information

First Posted
September 27, 2021
Last Updated
October 5, 2022
Sponsor
National Yang Ming University
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1. Study Identification

Unique Protocol Identification Number
NCT05090423
Brief Title
The Effect of Additional Neurodynamic Intervention in Patients With Chronic Ankle Instability
Official Title
The Effect of Additional Neurodynamic Intervention in Patients With Chronic Ankle Instability
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 5, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Yang Ming University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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. The investigators will recruit 40 patients with chronic ankle instability and compare the effect of two intervention groups (balance training alone, combined balance training and neurodynamic intervention for the common peroneal nerve) on ankle range of motion (ROM), active knee ROM, pressure pain threshold , Y balance test and Foot and ankle ability measure (FAAM). Independent test and Chi-square test are used to examine demographic data of the groups differences. Two-way repeated measures ANOVA is used to examine the intervention effect with the alpha level set at 0.05

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprains
Keywords
Chronic ankle instability, Neurodynamics, Mechanosensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: balance training alone
Arm Type
Experimental
Arm Description
The subjects will receive the balance training twice a week for 6 weeks.
Arm Title
Experimental: balance training and neurodynamic intervention for the common peroneal nerve
Arm Type
Experimental
Arm Description
The subjects will receive the balance training and neurodynamic intervention for the common peroneal nerve twice a week for 6 weeks.
Intervention Type
Other
Intervention Name(s)
balance training alone
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
balance training and neurodynamic intervention for the common peroneal nerve
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ankle range of motion
Description
Ask the person to face the wall and the tested foot in front, then the second toe and heel in the line is perpendicular to the wall. The contralateral limb is positioned behind the testing limb in a comfortable position and hands are placed on the wall in front to maintain stability. The gravity inclinometer is placed at the tibial tuberosity to measure the angle. The subjects will lunge forward trying to touch a vertical line on the wall with their knee, at the same time keeping heel contact with ground. Participants will perform three practice trials followed by 3 test trials and average the 3 tests.
Time Frame
pre-intervention
Title
Ankle range of motion
Description
Ask the person to face the wall and the tested foot in front, then the second toe and heel in the line is perpendicular to the wall. The contralateral limb is positioned behind the testing limb in a comfortable position and hands are placed on the wall in front to maintain stability. The gravity inclinometer is placed at the tibial tuberosity to measure the angle. The subjects will lunge forward trying to touch a vertical line on the wall with their knee, at the same time keeping heel contact with ground. Participants will perform three practice trials followed by 3 test trials and average the 3 tests.
Time Frame
post 6 weeks intervention
Title
Mechanosensitivity: Pain pressure threshold
Description
Using the plastic universal goniometer to measure the pain pressure threshold (PPT) of the anterior talofibular ligament, calcaneofibular ligament, peroneal nerve, peroneal longus muscle and peroneal brevis muscle. Measure a total of three times, and take a 30 seconds rest interval each time. In the end, the investigators will take average of the 3 tests.
Time Frame
pre-intervention
Title
Mechanosensitivity: Pain pressure threshold
Description
Using the plastic universal goniometer to measure the pain pressure threshold (PPT) of the anterior talofibular ligament, calcaneofibular ligament, peroneal nerve, peroneal longus muscle and peroneal brevis muscle. Measure a total of three times, and take a 30 seconds rest interval each time. In the end, the investigators will take average of the 3 tests.
Time Frame
post 6 weeks intervention
Title
Mechanosensitivity: Slump test with ankle plantar flexion and inversion to measure active knee range of motion
Description
The subjects sit on the edge of the bed without touching ground with their feet. The physical therapist assists the subjects to maintain the neutral pelvis position. First, ask the subjects flex the neck, trunk, and finally flex the lumbar to tighten the back. Second, while the subjects plantar and invert the ankle, participants will do the knee extension movement and record the angle of knee motion. Participants will perform three practice trials followed by 3 test trials and average the 3 tests.
Time Frame
pre-intervention
Title
Mechanosensitivity: Slump test with ankle plantar flexion and inversion to measure active knee range of motion
Description
The subjects sit on the edge of the bed without touching ground with their feet. The physical therapist assists the subjects to maintain the neutral pelvis position. First, ask the subjects flex the neck, trunk, and finally flex the lumbar to tighten the back. Second, while the subjects plantar and invert the ankle, participants will do the knee extension movement and record the angle of knee motion. Participants will perform three practice trials followed by 3 test trials and average the 3 tests.
Time Frame
post 6 weeks intervention
Title
Balance performance
Description
The subjects will stand on Y-balance kit and reach their legs alternatively to anterior, posterolateral and posteromedial direction with dominant leg first, in sequence. The subjects will practice 6 times first to familiarize the test procedure, then the final three measurements were collected and normalized with subject's lower limb length for statistical analysis.
Time Frame
pre-intervention
Title
Balance performance
Description
The subjects will stand on Y-balance kit and reach their legs alternatively to anterior, posterolateral and posteromedial direction with dominant leg first, in sequence. The subjects will practice 6 times first to familiarize the test procedure, then the final three measurements were collected and normalized with subject's lower limb length for statistical analysis.
Time Frame
post 6 weeks intervention
Title
Self-reported function: The Foot and Ankle Ability Measures (FAAM)
Description
The Foot and Ankle Ability Measures (FAAM) is a self-report measure that evaluate physical function of lower extremities musculoskeletal disorders. The measurement includes two parts, activities of daily living subscale of 21 items and sports subscale of 8 items. For each question, the subjects will chose the appropriate answer that most clearly describes their condition within the past week. It is based on the 4-0 scale. (4: no difficulty, 3: slight difficulty, 2: moderate difficulty, 1: extreme difficulty, 0: unable to do) If an activity in question is limited by something other than their foot or ankle, the patient is asked to record N/A. The sum of the scores in the two parts is less than ninety points, indicating that there is ankle instability
Time Frame
pre-intervention
Title
Self-reported function: The Foot and Ankle Ability Measures (FAAM)
Description
The Foot and Ankle Ability Measures (FAAM) is a self-report measure that evaluate physical function of lower extremities musculoskeletal disorders. The measurement includes two parts, activities of daily living subscale of 21 items and sports subscale of 8 items. For each question, the subjects will chose the appropriate answer that most clearly describes their condition within the past week. It is based on the 4-0 scale. (4: no difficulty, 3: slight difficulty, 2: moderate difficulty, 1: extreme difficulty, 0: unable to do) If an activity in question is limited by something other than their foot or ankle, the patient is asked to record N/A. The sum of the scores in the two parts is less than ninety points, indicating that there is ankle instability
Time Frame
post 6 weeks intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shih Yi-Fen, Ph.D
Phone
+886-2-28267340
Email
yfshih@nycu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Chen Hsin-I, B.S.
Phone
+886-982641541
Email
hsini0329@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shih Yi-Fen, Ph.D
Organizational Affiliation
Department of Physical Therapy and Assistive Technology, National Yang-Ming
Official's Role
Study Director
Facility Information:
Facility Name
National Yang Ming University
City
Taipei
ZIP/Postal Code
11221
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shih Yi-Fen, Ph.D
Phone
+886-2-2826-7340
Email
yfshih@ym.edu.tw

12. IPD Sharing Statement

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

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