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Comparing Two Training Frequencies of Balance Training for Chronic Ankle Instability

22 maggio 2026 aggiornato da: Xiaojing Huang, University of Utah

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.

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

57

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Cina
      • Beijing, Cina, 100084
        • Beijing Sport University

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  1. 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.
  2. At least two episodes of giving way, recurrent ankle sprains, or perceived ankle instability within 6 months prior to enrollment.
  3. Time since first ankle sprain greater than 12 months.
  4. Time since most recent ankle sprain greater than 3 months.
  5. No history of fracture or surgery in either lower extremity.
  6. No other injuries causing inability to bear weight on either lower extremity within the past 3 months.
  7. Cumberland Ankle Instability Tool (CAIT) score of 24 or below
  8. Physically active: engaging in at least 30 minutes of moderate or higher intensity physical activity on at least 3 days per week.
  9. Age 16-49 years.
  10. Willing to provide written informed consent -

Exclusion Criteria:

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 4-Week PHSB Training Group
Participants 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.
Comportamentale: PHSB Training - High Frequency Short Duration
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.
Sperimentale: 6-Week PHSB Training Group
Participants 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.
Comportamentale: PHSB Training - Low Frequency Long Duration
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.
Nessun intervento: Waitlist Control Group
Participants 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Cumberland Ankle Instability Tool (CAIT)
Lasso di tempo: Baseline (within 1 week before intervention) and post-intervention (within 1 week after completion of the training program)
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).
Baseline (within 1 week before intervention) and post-intervention (within 1 week after completion of the training program)
Y-Balance Test (YBT)
Lasso di tempo: Baseline (within 1 week before intervention) and post-intervention (within 1 week after completion of the training program)
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.
Baseline (within 1 week before intervention) and post-intervention (within 1 week after completion of the training program)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
SOT Sensory Ratios
Lasso di tempo: Baseline and post-intervention (within 1 week after completion of the training program)
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.
Baseline and post-intervention (within 1 week after completion of the training program)
SOT Balance Performance
Lasso di tempo: Baseline and post-intervention (within 1 week after completion of the training program)
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.
Baseline and post-intervention (within 1 week after completion of the training program)
Regional Plantar Pressure Distribution During Walking
Lasso di tempo: Baseline and post-intervention (within 1 week after completion of the training program)
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.
Baseline and post-intervention (within 1 week after completion of the training program)
Static Postural Stability Parameters During Single-Leg Stance
Lasso di tempo: Baseline and post-intervention (within 1 week after completion of the training program)
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.
Baseline and post-intervention (within 1 week after completion of the training program)
Romberg Index
Lasso di tempo: Baseline and post-intervention (within 1 week after completion of the training program)
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.
Baseline and post-intervention (within 1 week after completion of the training program)
Plantar Load Distribution Ratios During Walking
Lasso di tempo: Baseline and post-intervention (within 1 week after completion of the training program)
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.
Baseline and post-intervention (within 1 week after completion of the training program)
Side-Hop Test
Lasso di tempo: Baseline and post-intervention (within 1 week after completion of the training program)
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.
Baseline and post-intervention (within 1 week after completion of the training program)
Ankle Range of Motion
Lasso di tempo: Baseline and post-intervention (within 1 week after completion of the training program)
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.
Baseline and post-intervention (within 1 week after completion of the training program)
Ankle Muscle Strength
Lasso di tempo: Baseline and post-intervention (within 1 week after completion of the training program)
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.
Baseline and post-intervention (within 1 week after completion of the training program)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Utah

Collaboratori

Beijing Sport University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

8 novembre 2023

Completamento primario (Effettivo)

17 gennaio 2025

Completamento dello studio (Effettivo)

16 marzo 2025

Date di iscrizione allo studio

Primo inviato

19 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

22 maggio 2026

Primo Inserito (Effettivo)

28 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

28 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

22 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 2024034H

Piano per i dati dei singoli partecipanti (IPD)

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INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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