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Chronic Ankle Instability, CAINCT07612358

Comparing Two Training Frequencies of Balance Training for Chronic Ankle Instability

A study testing PHSB Training - High Frequency Short Duration and PHSB Training - Low Frequency Long Duration in people with Chronic Ankle Instability, CAI and Chronic Ankle Instability, run by University of Utah at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study compares two progressive hop-to-stabilization balance (PHSB) training schedules with equal total training volume in people with chronic ankle instability (CAI). Current evidence supports the effectiveness of PHSB training for CAI rehabilitation, but no study has directly compared different training… Read more about this study

Who is it for?
Ages 16 to 49 years
What is being tested?
PHSB Training - High Frequency Short Duration and PHSB Training - Low Frequency Long Duration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
1 siteChina
Study dates
8 Nov 2023to 16 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 49 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • History of at least one lateral ankle sprain with inflammatory signs (swelling, pain) and inability to bear weight on the affected side for at least one day after injury, per International Ankle Consortium criteria.
  • At least two episodes of giving way, recurrent ankle sprains, or perceived ankle instability within 6 months prior to enrollment.
  • Time since first ankle sprain greater than 12 months.
  • Time since most recent ankle sprain greater than 3 months.
  • No history of fracture or surgery in either lower extremity.
  • No other injuries causing inability to bear weight on either lower extremity within the past 3 months.
Show all 10Show fewer
  • Cumberland Ankle Instability Tool (CAIT) score of 24 or below
  • Physically active: engaging in at least 30 minutes of moderate or higher intensity physical activity on at least 3 days per week.
  • Age 16-49 years.
  • Willing to provide written informed consent -

Who cannot join

  • History of lower extremity surgery or lower extremity fracture affecting lower limb function
  • Acute ankle sprain within 6 weeks prior to enrollment
  • Foot or ankle immobilization for more than 48 hours within the past 6 months
  • Neurological, vestibular, or other medical conditions affecting muscle strength or proprioceptive function
  • Currently receiving other rehabilitation treatment for the ankle -

Trial locations and contacts

1 site in 1 country.

China1 site
  • Beijing Sport University

    Beijing, 100084

Other trials in China

About this study

Official title: Comparing Two Training Frequencies of Dose-equivalent Hop-to-stabilization Balance Training on Sensorimotor Function and Plantar Biomechanics in Chronic Ankle Instability: a Randomized Controlled Trial

This study compares two progressive hop-to-stabilization balance (PHSB) training schedules with equal total training volume in people with chronic ankle instability (CAI). Current evidence supports the effectiveness of PHSB training for CAI rehabilitation, but no study has directly compared different training frequencies when total training dose is held constant.

Sixty participants with CAI were randomly assigned to three groups: a 4-week group (3 sessions per week, 12 sessions total, n=23), a 6-week group (2 sessions per week, 12 sessions total, n=22), and a waitlist control group (n=12). Each session lasted 20 minutes and followed the standardized PHSB protocol, including single-limb hops to stabilization, hops to stabilization and reach, unanticipated hop to stabilization, and single-limb stance activities with progressive difficulty. The control group received the intervention after study completion.

Read more

The primary outcomes are sensory organization measured by the Sensory Organization Test (composite score, six condition equilibrium scores, and four sensory ratios for somatosensory, visual, vestibular, and visual preference) and strategy analysis scores, and regional plantar pressure distribution during walking measured by FreeSTEP (peak force normalized to body weight across the first through fifth metatarsal heads, hallux, medial hindfoot, and lateral hindfoot).

Secondary outcomes include self-reported ankle function (Cumberland Ankle Instability Tool), dynamic balance (Y-Balance Test and side-hop test), static postural stability during single-leg stance measured by FreeSTEP (center of pressure mean velocity, confidence ellipse area, sway length, anteroposterior and mediolateral standard deviation of COP displacement, and Romberg index calculated as eyes-closed to eyes-open ratio of ellipse area), forefoot-rearfoot and medial-lateral plantar load ratios during walking, ankle range of motion measured by goniometer, and ankle muscle strength assessed by manual muscle testing.

This study aims to determine whether different training frequency schedules produce similar or distinct rehabilitation outcomes across sensorimotor, biomechanical, and patient-reported domains, providing evidence for flexible and individualized exercise prescription in CAI management.

Being tested
PHSB Training - High Frequency Short Duration, PHSB Training - Low Frequency Long Duration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PHSB Training - High Frequency Short DurationBehavioural

    Standardized progressive hop-to-stabilization balance training performed 3 times per week for 4 weeks (12 sessions, 20 minutes per session, 240 minutes total). Training sessions were scheduled with approximately equal inter-session intervals (48-72 hours). The protocol consisted of four components with progressive difficulty levels: (1) single-limb stance activities under eyes-open and eyes-closed conditions on firm and foam surfaces with 7 levels, (2) single-limb hops to stabilization in four directions at three distances (45, 68, 91 cm) with 7 levels, (3) hops to stabilization and reach with 7 levels, and (4) unanticipated hop to stabilization using a numbered 9-grid system with 7 levels. Progression occurred when participants completed a level without errors. n=23.

  • PHSB Training - Low Frequency Long DurationBehavioural

    Identical progressive hop-to-stabilization balance training protocol as Intervention 1, performed 2 times per week for 6 weeks (12 sessions, 20 minutes per session, 240 minutes total). Training sessions were scheduled with approximately equal inter-session intervals (72-96 hours). Training content, progression criteria, difficulty levels, and exercise components were the same as the 4-week protocol. The only difference was the distribution of training sessions across a longer period at a lower weekly frequency. n=22.

Study groups in NCT07612358
Study groupRoleWhat they receive
4-Week PHSB Training GroupExperimentalParticipants received progressive hop-to-stabilization balance training 3 times per week for 4 weeks (12 sessions total, 20 minutes per session). The training protocol included four components: single-limb stance activities with 7 progressive difficulty levels under eyes-open and eyes-closed conditions, single-limb hops to stabilization in four directions at three distances (45cm, 68cm, 91cm), hops to stabilization and reach with 7 progressive levels, and unanticipated hop to stabilization using a 9-grid system with 7 progressive levels. Training sessions were scheduled with approximately equal inter-session intervals (48-72 hours between sessions). n=23.
Receives: Behavioral: PHSB Training - High Frequency Short Duration
6-Week PHSB Training GroupExperimentalParticipants received the same progressive hop-to-stabilization balance training protocol as the 4-week group, but at a frequency of 2 times per week for 6 weeks (12 sessions total, 20 minutes per session). Training content, progression criteria, and difficulty levels were identical to the 4-week group. Training sessions were scheduled with approximately equal inter-session intervals (72-96 hours between sessions).n=22.
Receives: Behavioral: PHSB Training - Low Frequency Long Duration
Waitlist Control GroupNo interventionParticipants received no therapeutic intervention during the study period. Health education was provided during the waiting period. All control group participants were offered the PHSB training program upon completion of the study to ensure ethical treatment. n=12.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumberland Ankle Instability Tool (CAIT)

    Self-reported ankle function questionnaire assessing perceived ankle instability during daily and sporting activities. Total score ranges 0-30, with higher scores indicating better ankle stability. A score below 24 indicates chronic ankle instability per International Ankle Consortium criteria. The minimal clinically important difference is 3 points. The Chinese version has demonstrated high internal consistency (Cronbach alpha 0.815) and test-retest reliability (ICC 0.99).

    Measured: Baseline (within 1 week before intervention) and post-intervention (within 1 week after completion of the training program)

  2. Y-Balance Test (YBT)

    Dynamic balance assessment measuring maximum reach distance in three directions (anterior, posteromedial, posterolateral) during single-leg stance on the affected limb. Reach distances were normalized to limb length and expressed as percentage. Three trials per direction with the best value selected, and the average of three directions used as the final score. Higher scores indicate better dynamic balance.

    Measured: Baseline (within 1 week before intervention) and post-intervention (within 1 week after completion of the training program)

Secondary outcomes (9)
  1. SOT Sensory Ratios

    Four sensory ratios derived from the Sensory Organization Test: somatosensory ratio (Condition 2 / Condition 1), visual ratio (Condition 4 / Condition 1), vestibular ratio (Condition 5 / Condition 1), and visual preference ratio ((Condition 3 + Condition 6) / (Condition 2 + Condition 5)). Higher scores indicate better utilization of the corresponding sensory system for postural control. These ratios assess changes in sensory reweighting strategies following intervention.

    Measured: Baseline and post-intervention (within 1 week after completion of the training program)

  2. SOT Balance Performance

    Composite equilibrium score (overall balance, range 0-100), individual equilibrium scores for each of the six Sensory Organization Test conditions (Condition 1 through Condition 6, each range 0-100), and strategy analysis scores indicating the relative use of ankle-dominant versus hip-dominant postural control strategies. Higher equilibrium and strategy scores indicate better balance performance. Assessed using a virtual dynamic balance testing system.

    Measured: Baseline and post-intervention (within 1 week after completion of the training program)

  3. Regional Plantar Pressure Distribution During Walking

    Peak force normalized to body weight (PF/W, N/kg) at eight anatomical foot regions during level walking, measured by FreeSTEP system at 200 Hz sampling frequency: first through fifth metatarsal heads (M1-M5), hallux (T1), medial hindfoot (HM), and lateral hindfoot (HL). Data collected over 30 seconds of steady-state walking and averaged across 9 representative gait cycles. Changes in regional pressure distribution reflect altered foot loading patterns and ankle inversion tendency.

    Measured: Baseline and post-intervention (within 1 week after completion of the training program)

  4. Static Postural Stability Parameters During Single-Leg Stance

    Center of pressure parameters during 10-second single-leg stance on the affected limb, measured by FreeSTEP system under both eyes-open and eyes-closed conditions: COP mean velocity (mm/s), confidence ellipse area (mm2), sway length (mm), and standard deviation of COP displacement in anteroposterior (SD-Y) and mediolateral (SD-X) directions. Three trials per condition with 60-second rest intervals, averaged for analysis. Lower values indicate better postural stability.

    Measured: Baseline and post-intervention (within 1 week after completion of the training program)

  5. Romberg Index

    Ratio of eyes-closed to eyes-open postural stability parameters calculated from FreeSTEP single-leg stance data, including confidence ellipse area ratio, sway length ratio, and COP velocity ratio. Higher values indicate greater reliance on visual input for postural control. A decrease following intervention suggests reduced visual dependence and improved proprioceptive and vestibular contributions to balance.

    Measured: Baseline and post-intervention (within 1 week after completion of the training program)

  6. Plantar Load Distribution Ratios During Walking

    Forefoot-to-rearfoot and medial-to-lateral plantar load distribution ratios (%) during walking, measured by FreeSTEP dynamic analysis. Changes in these ratios reflect shifts in overall foot loading strategy related to ankle inversion tendency in individuals with chronic ankle instability.

    Measured: Baseline and post-intervention (within 1 week after completion of the training program)

  7. Side-Hop Test

    Timed functional performance test measuring the time required to complete 10 lateral hops over two lines spaced 30 cm apart on the affected limb, performed barefoot. Three trials with the best time recorded. Shorter completion time indicates better dynamic ankle function and neuromuscular control.

    Measured: Baseline and post-intervention (within 1 week after completion of the training program)

  8. Ankle Range of Motion

    Active ankle joint range of motion measured by goniometer, including dorsiflexion, plantarflexion, inversion, and eversion of the affected ankle, recorded in degrees. Three trials per direction will be performed, and the maximum value will be used for analysis. This measure provides information on peripheral musculoskeletal adaptations following training.

    Measured: Baseline and post-intervention (within 1 week after completion of the training program)

  9. Ankle Muscle Strength

    Isometric ankle muscle strength of dorsiflexors, plantarflexors, invertors, and evertors assessed using a hand-held dynamometer and recorded in Newtons. Three trials per direction will be performed, and the maximum value will be used for analysis. This measure provides information on peripheral musculoskeletal adaptations following training.

    Measured: Baseline and post-intervention (within 1 week after completion of the training program)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2026
  2. Study start8 Nov 2023
  3. Primary completion17 Jan 2025
  4. Study completion16 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants were randomly assigned in a 2:2:1 ratio to one of three parallel groups: a 4-week high-frequency PHSB training group, a 6-week low-frequency PHSB training group, or a waitlist control group. The two training groups received the same total training volume (12 sessions, 20 minutes each, 240 minutes total) but differed in weekly frequency and overall duration. The control group received no intervention during the study period and was offered the training upon study completion.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07612358
Sponsor's protocol ID
2024034H
Status last verified
May 2026
First submitted
19 May 2026
Last updated
28 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing PHSB Training - High Frequency Short Duration and PHSB Training - Low Frequency Long Duration in people with Chronic Ankle Instability, CAI and Chronic Ankle Instability, run by University of Utah at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumberland Ankle Instability Tool (CAIT) (time frame: Baseline (within 1 week before intervention) and post-intervention (within 1 week after completion of the training program)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.

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