NCT05090423

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

January 5, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

January 15, 2026

Completed
Last Updated

January 15, 2026

Status Verified

December 1, 2025

Enrollment Period

2.5 years

First QC Date

September 27, 2021

Results QC Date

July 22, 2024

Last Update Submit

December 24, 2025

Conditions

Keywords

Chronic ankle instabilityNeurodynamicsMechanosensitivity

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

EXPERIMENTAL

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

Other: balance training alone

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

EXPERIMENTAL

The subjects will receive the 12 sessions of balance training and neurodynamic intervention for the common peroneal nerve over six to eight weeks.

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

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.

Experimental: balance training alone

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.

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

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Results Point of Contact

Title
Chen Hsin-I, Physical Therapist
Organization
National Yang Ming Chiao Tung University

Study Officials

  • Shih Yi-Fen, Ph.D

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

    STUDY DIRECTOR

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

Locations