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

NCT ID: NCT05090423

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-05
• Study Completion Date: 2024-06-30

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).

Conditions

Ankle Sprains

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental: balance training alone

The subjects will receive 12 sessions of balance training over six to eight weeks.

Group Type: EXPERIMENTAL

balance training alone

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

balance training and neurodynamic intervention for the common peroneal nerve

Intervention Type: OTHER

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.

Interventions

balance 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.

Intervention Type: OTHER

balance 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Yang Ming Chiao Tung University

OTHER

Sponsor Role: lead

Responsible Party

Yi-Fen Shih

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shih Yi-Fen, Ph.D

Role: STUDY_DIRECTOR

Department of Physical Therapy and Assistive Technology, National Yang-Ming

Locations

National Yang Ming University

Taipei, , Taiwan

Countries

Taiwan

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

YM110112F

Identifier Type: -

Identifier Source: org_study_id