The Effect of Additional Neurodynamic Intervention in Patients With Chronic Ankle Instability
1 other identifier
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2021
CompletedFirst Posted
Study publicly available on registry
October 22, 2021
CompletedStudy Start
First participant enrolled
January 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedResults Posted
Study results publicly available
January 15, 2026
CompletedJanuary 15, 2026
December 1, 2025
2.5 years
September 27, 2021
July 22, 2024
December 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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.
Within one week after 12 treatment sessions
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.
Within one week after 12 treatment sessions
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.
Within one week after 12 treatment session
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.
Within one week after 12 treatment sessions
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.
Within one week after 12 treatment sessions
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.
Within one week after 12 treatment sessions
Secondary Outcomes (9)
Y Balance Test- Anterior Direction
Within one week after 12 treatment sessions
The Foot and Ankle Ability Measures- Sports
Within one week after 12 treatment sessions
The Foot and Ankle Ability Measures- Activity of Life
Within one week after 12 treatment sessions
Weight Bearing Lunge Test
Within one week after 12 treatment sessions
Hamstring Flexibility
Within one week after 12 treatment sessions
- +4 more secondary outcomes
Study Arms (2)
Experimental: balance training alone
EXPERIMENTALThe subjects will receive 12 sessions of balance training over six to eight weeks.
Experimental: balance training and neurodynamic intervention for the common peroneal nerve
EXPERIMENTALThe subjects will receive the 12 sessions of balance training and neurodynamic intervention for the common peroneal nerve over six to eight weeks.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Yang Ming University
Taipei, 11221, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chen Hsin-I, Physical Therapist
- Organization
- National Yang Ming Chiao Tung University
Study Officials
- STUDY DIRECTOR
Shih Yi-Fen, Ph.D
Department of Physical Therapy and Assistive Technology, National Yang-Ming
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 27, 2021
First Posted
October 22, 2021
Study Start
January 5, 2022
Primary Completion
June 30, 2024
Study Completion
June 30, 2024
Last Updated
January 15, 2026
Results First Posted
January 15, 2026
Record last verified: 2025-12