NCT06801483

Brief Summary

Chronic ankle instability (CAI) is a common complication following an ankle sprain, affecting joint stability and leading to decreased muscle strength and poor neuromuscular control. These symptoms can significantly impact athletes' sports performance. Rehabilitation training for CAI majorly involves strengthening or balance training. Few studies have discussed treatment plans that combine the above two training, and the effectiveness of combined training is similar to that of single training content. Due to the lack of machines to train ankle strength, thera-bands were often used for ankle strengthening. However, the resistance thera-bands provide is limited and may need more for athletes requiring high-intensity training. In recent years, a local company has developed a multiaxial ankle training system for machine-based ankle strengthening. This machine allows for training the ankle joint in various directions while sitting and can provide greater training resistance. As this machine has recently been developed and there is seldom evidence for its use in training, this project aims to discuss the effectiveness of using the ankle training machine in athletes with chronic ankle instability. This study will compare the differences in muscle strength, morphology, muscle material properties, balance ability, and functional performance of athletes after a six-week combined training program with thera-band or the multiaxial ankle training system for providing resistance. Thereby establishing a training plan for athletes suffering from chronic ankle instability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2024

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

Study Start

First participant enrolled

August 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 21, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 30, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

January 21, 2025

Last Update Submit

March 19, 2026

Conditions

Keywords

progressive trainingstrengtheningbalance trainingchronic ankle instabilityankle training machine

Outcome Measures

Primary Outcomes (4)

  • Muscle Morphology

    Using ultrasound to measure the muscle morphology of the peronous longus, gastrocnemius, tibialis anterior.

    At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks

  • Y-Balance Test

    This test is divided into three directions: anterior, posteromedial, and posterolateral. Each direction has a commercial measuring tape attached at 135 degrees, 90 degrees, and 135 degrees, respectively. The subject stands in the middle of the three measuring tapes, with the test foot's toe placed at the intersection point. The subject then stands on one leg with the test foot, extends the non-weight-bearing foot to touch the measuring tape in the target direction without touching the ground, and returns to the starting position while maintaining balance.

    At enrollment (1st week), midterm of training (3rd. week) and the end of training at 6 weeks

  • Countermovement Jump

    Before the test, wireless EMG sensors are attached to the tibialis anterior, The test is performed on a force plate. The subject stands on the force plate, bends both knees to 90 degrees, and jumps as high as possible.

    At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks

  • Triple Hop Test

    The subject stands with both feet at the starting point in front of the force plate, then stands on one foot and performs three consecutive forward hops, with the first hop landing on the force plate.

    At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks

Secondary Outcomes (9)

  • Ankle muscle strength

    At enrollment (1st. week) and the end of intervention at 6 weeks

  • Muscle tension

    At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks

  • Muscle stiffness

    At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks

  • Muscle elasticity

    At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks

  • Muscle stress relaxation time

    At enrollment (1st. week), midterm of training (3rd. week) and the end of training at 6 weeks

  • +4 more secondary outcomes

Study Arms (2)

multiaxial ankle training system

EXPERIMENTAL

These subjects will train their ankle strength by the multiaxial ankle training system

Other: Strengthening

thera-band

ACTIVE COMPARATOR

These subjects will train their ankle strength by thera-band

Other: Strengthening

Interventions

All subjects will recieve an ankle muscle strenghening training program twice a week for six weeks.

multiaxial ankle training systemthera-band

Eligibility Criteria

Age18 Years - 28 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Unilateral CAI: Cumberland Ankle Instability Tool (CAIT) score ≤ 24
  • Age between 18 and 28 years
  • Engages in sports training at least 3 days a week, for more than 1 hour each session
  • Able to perform training and assessment movements

You may not qualify if:

  • Bilateral CAI
  • Less than 6 months since the first ankle sprain
  • Acute ankle sprain within the last 6 weeks
  • Foot or ankle surgery within the last 3 months
  • Neuromuscular diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University

Taichung, Taiwan

Location

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Chia-Ming Chang, Ph.D.

    China Medical University, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2025

First Posted

January 30, 2025

Study Start

August 1, 2024

Primary Completion

December 20, 2024

Study Completion

January 31, 2026

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations